Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
Community Blood Centers of South Florida, Inc.
Blood products, labeled leukoreduced which did not meet the requirements for leukoreduced products, were distributed.
Blood products, which did not meet the specified pH for platelets, were distributed.
Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.
Blood and Blood Products for Reprocessing
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Blood products, which did not meet the acceptable product specifications, were distributed.
Blood products, which were labeled as leukoreduced, but were not tested to verify the White Blood Cell count, were distributed.
Blood products, collected from a donor who was permanently deferred after testing reactive for Hepatitis B surface antigen (HbSAg), were distributed.
Blood product, manufactured from Whole Blood units that may have had an extended collection time, was distributed.
Red Blood Cells Leukocytes Reduced Irradiated
Blood product, which was not manufactured in accordance to acceptable product specifications, was distributed.
Blood products, collected from a donor whose temperature was not documented, were distributed.
Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.
Blood products, with unacceptable, undocumented, or incomplete product QC, were distributed.
Hoxworth Blood Center University of Cincinnati Medical Center
Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Blood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed.
Switzerland, ID, Alaska, HI, CA, FL, TN, OR, NY
Blood products, collected from a donor who emigrated from an area considered at risk for human immunodeficiency virus (HIV) Group O, were distributed.
Blood products, which were not screened for antibodies according to the reagent manufacturer's instructions, were distributed.
Red Blood Cells (Apheresis) Leukocytes Reduced
Red Blood Cells Leukocytes Removed Washed
Blood products, collected from a donor whose close contact with partner who emigrated from an area at risk for HIV-Group O, were distributed.
Blood products, which may have been exposed to unacceptable temperature during storage, were distributed.
Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
Worldwide distribution: USA (nationwide) and countries of: Canada, Japan, and Taiwan.
Fisher & Paykel  Healthcare ICON CPAP (continuous positive airway pressure).     Models:     ICON Auto:  ICONAAN, ICONAAN-HT, ICONAAJ.   ICON Novo:  ICONNAN, ICONNAN-HT, ICONNAJ.   ICON Premo:  ICONPBN, ICONPBN-HT, ICONPBN-HTC.      The ICON CPAP unit is for use on adult patients for the treatment of Obstructive Sleep Apnea (OSA). The device is for use in the home or sleep laboratory. The device is not intended to be used as a life supporting device.
Fisher and Paykel Healthcare is recalling the ICON CPAP units because there is a potential power issue on certain ICON CPAP.  These ICON CPAP units could potentially become inoperable, which would result in a lack of treatment to the patient's obstructive sleep apnea symptoms until a replacement unit is obtained.
Blood product, which may have been contaminated during collection, was distributed.
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Blood products, collected using a copper sulfate solution which had unacceptable specific gravity QC results were distributed.
Blood products, collected using a copper sulfate solution which had unacceptable specific gravity QC results, were distributed.
Blood products, labeled 'leukocytes reduced' which did not meet the QC requirements for leukoreduced products, were distributed.
Blood products, collected from a donor who received a tattoo within 12 months of donating, were distributed.
Blood products, collected from a donor who was previously deferred for possibly exposure to vCJD, were distributed.
Platelets Pheresis Leukocytes Reduced Irradiated
Blood products, collected using equipment that had not been validated, were distributed.
Blood products, collected from a donor who was previously deferred after receiving a tattoo within a year of donating, were distributed.
Preserved Apricots -- NET WEIGHT 300gr (10.6oz) -- Ingredient: Salt, apricot, refined sugar.  Firm on label: packed for Hong Lee Trading Inc., 225 Johnson Ave., Brooklyn, NY 11203.  Product of Vietnam.
The product contained undeclared sulfites (108.8 ppm)  and undeclared Yellow #5 based on sampling and analysis by New York State Department of Agriculture and Markets.
Orthovita, Inc., dBA Stryker Orthobiologics.
USA Nationwide Distribution in the states of AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KS, KY, LA, MD, ME, MI, MO, NC, ND, NH, NJ, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, and WI.
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System, 4'', Part Number 2090-0502        Product Usage:   Facilitate placement of bone cement in weakened or diminished bone
Manufacturer Part Number 2090-0502, Lot Number Q1006003
There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures.  This has been attributed to bending of the catheter during the retraction from the needle.  It was determined to be use errors.  The correction is limited to a revision of the Directions for Use.
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System, 6'', Part Number 2090-0505     Product Usage:   Facilitate placement of bone cement in weakened or diminished bone
Manufacturer Part Number 2090-0505, Lot Number A1006027
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System, 4'', Part Number 2090-0501     Product Usage:   Facilitate placement of bone cement in weakened or diminished bone
Manufacturer Part Number 2090-0501, Lot Numbers A1109035 and Q1006002
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Syringe Delivery System, 6'', Part Number 2090-0504     Product Usage:   Facilitate placement of bone cement in weakened or diminished bone
Manufacturer Part Number 2090-0504, Lot Numbers A1006026 and A1111020
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Beveled Needle, 4'', Part Number 2110-0505       Product Usage:   Facilitate placement of bone cement in weakened or diminished bone
Manufacturer Part Number 2110-0505, Lot Numbers E909002 and E909002R
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Catheter, 8'', Part Number 2110-0526     Product Usage:   Facilitate placement of bone cement in weakened or diminished bone
Manufacturer Part Number 2110-0526, Lot Numbers E908004R and E908004
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger, 6'', Part Number 2110-0501     Product Usage:   Facilitate placement of bone cement in weakened or diminished bone
Manufacturer Part Number 2110-0501, Lot Numbers E909004R and E909004
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Diamond Needle, 4'', Part Number 2110-0506     Product Usage:   Facilitate placement of bone cement in weakened or diminished bone
Manufacturer Part Number 2110-0506, Lot Number E909005R
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Reamer, 8'', Part Number 2110-0525     Product Usage:   Facilitate placement of bone cement in weakened or diminished bone
Manufacturer Part Number 2110-0525, Lot Numbers E909006R
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Reamer, 6'', Part Number 2110-0504     Product Usage:   Facilitate placement of bone cement in weakened or diminished bone
Manufacturer Part Number 2110-0504, Lot Number E909007R
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger, 8'', Part Number 2110-0502      Product Usage:   Facilitate placement of bone cement in weakened or diminished bone
Manufacturer Part Number 2110-0502, Lot Number E909008R
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Beveled Needle, 6'', Part Number 2110-0524     Product Usage:   Facilitate placement of bone cement in weakened or diminished bone
Manufacturer Part Number 2110-0524, Lot Number E909009R and E909009R
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Catheter, 6'', Part Number 2110-0503     Product Usage:   Facilitate placement of bone cement in weakened or diminished bone
Manufacturer Part Number 2110-0503, Lot Numbers E908003R and E908002
Whole Foods Mini Peanut Butter Cookies 12 pack sold in small, plain brown bags featuring a cellophane window on the front with an oval Whole Foods Market sticker that reads ''mini peanut butter cookies - OLD-FASHIONED TREATS FROM WHOLE FOOD MARKET-''  PLU 22096100000
All cookies sold before September 29, 2012, manufactured from May 1, 2012 to September 24, 2012
The cookies were manufactured using peanut butter recalled by Sunland, Inc. for salmonella
Whole Foods 3 oz Peanut Butter Cookies sold under PLU 47963 from the retail store self-serve pastry case.
All cookies sold before September 29, 2012, manufactured from May 1, 2012 to September 24, 2012,
The cookies were manufactured using peanut butter recalled by Sunland, Inc. for salmonella.
Whole Foods 3 oz  Peanut Butter Chocolate Chunk Cookies sold under PLU 47963 from the retail store self-serve pastry case.
All cookies sold before September 29, 2012, manufactured from May 1, 2012 to September 24, 2012.
CA, IA, MI, MO, NC, NV, NY, OH, PA, TX, UT, WI and Canada
Peanut Butter Ribbon, 40 lb Pail, Item Numbers 07-012-40, 07-212-40, and 49-00100-40, Manufactured by Pecan Deluxe Candy Company, 2570 Lone Star Drive, Dallas, TX 75212
The Peanut Butter products were manufactured using peanut butter recalled by Sunland, Inc. for salmonella.
Peanut Butter Crunch, 45 lb Case, Item Number 01-326-45, Manufactured by Pecan Deluxe Candy Company, 2570 Lone Star Drive, Dallas, TX 75212
Peanut Butter Fudge Ribbon, 50 lb Pail, Item Number 07-094-50, Manufactured by Pecan Deluxe Candy Company, 2570 Lone Star Drive, Dallas, TX 75212
The Peanut Butter Ribbon and Chunky Peanut Butter Ribbon were manufactured using peanut butter recalled by Sunland, Inc. for salmonella.
Chunky Peanut Butter Ribbon, 40 lb Pail, Item Number 07-712-40, Manufactured by Pecan Deluxe Candy Company, 2570 Lone Star Drive, Dallas, TX 75212
Peanut Butter Base, 30 lb Pail, Item Numbers 08-010-30, 08-310-30, and 08-810-30, Manufactured by Pecan Deluxe Candy Company, 2570 Lone Star Drive, Dallas, TX 75212
The macadamia nuts have the potential to be contaminated with Salmonella.
Worldwide Distribution - USA Nationwide and the countries of Canada, Australia, Belgium, Czech Republic, France, French Polynesia, Germany, Greece, Hong Kong, Ireland, Italy, Japan, Jordon, Kuwait, Lebanon, Malawi, Morocco, Namibia, Netherlands, oman, Panama, Paraguay, Qatar, Reunion, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom
Synchron LX System(s) and UniCel DxC 600/800 System(s) Lactate Reagent, Part Number: A95550     Product Usage:  Lactate (LACT) reagent, when used in conjunction with Synchron LX System(s), UniCel DxC 600/800 System(s) and Synchron Systems Multi Calibrator, is intended for the quantitative determination of lactate concentration in human plasma and cerebrospinal fluid (CSF).
Beckman Coulter initiated the recall for the Lactate Assay (LACT) Lot M206209 as they received a customer complaint of error message (RXN RATE HI), i.e. no numerical values reported for samples containing Lactate concentration greater than 6.5 mmol/L.
USA Nationwide Distribution in the states of MS: TX, NV, CA, MD, and WI.
45 mm Screw, Item #BG7045     Product Usage:   Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.
The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
50 mm Screw, Item #BG7050     Product Usage:   Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.
Set Screw, Item #BG3010     Product Usage:   Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.
40 mm Rod, Item #BG1640     Product Usage:   Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.
50 mm Rod, Item #BG1650     Product Usage:   Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.
60 mm Rod, Item #BG1660     Product Usage:   Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.
12mm x 27mm x 8mm   12mm x 27mm x 9mm    12mm x 27mm x 10mm    12mm x 27mm x 11mm    12mm x 27mm x 12mm    12mm x 27mm x 13mm    12mm x 27mm x 14mm      Product Usage:   Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.
14 x 11 x 6mm 7 deg   14 x 11 x 7mm 7 deg    14 x 11 x 8mm 7 deg    14 x 11 x 9mm 7 deg    14 x 11 x 10mm 7 deg    14 x 11 x 11mm 7 deg    14 x 11 x 12mm 7 deg       Product Usage:   Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.
Copperhead IBFD, Large Neutral, 6mm   Copperhead IBFD, Large Neutral, 7mm    Copperhead IBFD, Large Neutral, 8mm    Copperhead IBFD, Large Neutral, 9mm    Copperhead IBFD, Large Neutral, 10mm    Copperhead IBFD, Large Neutral, 11mm      Product Usage:   Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.
Fang Screw 20mm   Fang Plate 21mm      Product Usage:   Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.
Nationwide Distribution including the states of CA, MD, TX, NV, and WI.
Femoral component, CR, cemented, #1, left 2103-1310  Femoral component, CR, cemented, #2, left 2103-1320   Femoral component, CR, cemented, #3, left 2103-1330   Femoral component, CR, cemented, #4, left 2103-1340   Femoral component, CR, cemented, #5, left 2103-1350   Femoral component, CR, cemented, #6, left 2103-1360   Femoral component, CR, cemented, #1, right 2103-1410   Femoral component, CR, cemented, #2, right 2103-1420   Femoral component, CR, cemented, #3, right 2103-1430   Femoral component, CR, cemented, #4, right 2103-1440   Femoral component, CR, cemented, #5, right 2103-1450   Femoral component, CR, cemented, #6, right 2103-1460   Femoral component, PS, #1, left 2103-3110   Femoral component, PS, #2, left 2103-3120   Femoral component, PS, #3, left 2103-3130   Femoral component, PS, #4, left 2103-3140   Femoral component, PS, #5, left 2103-3150   Femoral component, PS, #6, left 2103-3160   Femoral component,PS, #1, right 2103-3210   Femoral component,PS, #2, right 2103-3220   Femoral component,PS, #3, right 2103-3230   Femoral component,PS, #4, right 2103-3240   Femoral component,PS, #5, right 2103-3250   Femoral component,PS, #6, right 2103-3260      Variety of hip and knee implants and instruments, multiple uses.
The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician  and for every surgery.
Tibial baseplate,cemented,#1 2203-3010  Tibial baseplate,cemented,#2 2203-3020   Tibial baseplate,cemented,#3 2203-3030   Tibial baseplate,cemented,#4 2203-3040   Tibial baseplate, cemented, #5 2203-3050   Tibial baseplate, cemented, #6 2203-3060   Tibial insert,CR,plained,#1,9mm 2303-1211   Tibial insert,CR,plained,#1,11mm 2303-1212   Tibial insert,CR,plained,#1,13mm 2303-1213   Tibial insert,CR,plained,#1,15mm 2303-1214   Tibial insert,CR,plained,#1,18mm 2303-1215   Tibial insert,CR,plained,#2,9mm 2303-1221   Tibial insert,CR,plained,#2,11mm 2303-1222   Tibial insert,CR,plained,#2,13mm 2303-1223   Tibial insert,CR,plained,#2,15mm 2303-1224   Tibial insert,CR,plained,#2,18mm 2303-1225   Tibial insert,CR,plained,#3,9mm 2303-1231   Tibial insert,CR,plained,#3,11mm 2303-1232   Tibial insert,CR,plained,#3,13mm 2303-1233   Tibial insert,CR,plained,#3,15mm 2303-1234   Tibial insert,CR,plained,#3,18mm 2303-1235   Tibial insert,CR,plained,#4,9mm 2303-1241   Tibial insert,CR,plained,#4,11mm 2303-1242   Tibial insert,CR,plained,#4,13mm 2303-1243   Tibial insert,CR,plained,#4,15mm 2303-1244   Tibial insert,CR,plained,#4,18mm 2303-1245   Tibial insert,CR,plained,#5,9mm 2303-1251   Tibial insert,CR,plained,#5,11mm 2303-1252   Tibial insert,CR,plained,#5,13mm 2303-1253   Tibial insert,CR,plained,#5,15mm 2303-1254   Tibial insert,CR,plained,#5,18mm 2303-1255   Tibial insert,CR,plained,#6,9mm 2303-1261   Tibial insert,CR,plained,#6,11mm 2303-1262   Tibial insert,CR,plained,#6,13mm 2303-1263   Tibial insert,CR,plained,#6,15mm 2303-1264   Tibial insert,CR,plained,#6,18mm 2303-1265   Tibial insert, PS , #1, 9mm 2303-3011   Tibial insert, PS , #1, 11mm 2303-3012   Tibial insert, PS , #1, 13mm 2303-3013   Tibial insert, PS , #1, 15mm 2303-3014   Tibial insert, PS , #1, 18mm 2303-3015   Tibial insert, PS , #2, 9mm 2303-3021   Tibial insert, PS , #2, 11mm 2303-3022   Tibial insert, PS , #2, 13mm 2303-3023   Tibial insert, PS , #2, 15mm 2303-3024   Tibial insert, PS , #2, 18mm 2303-3025   Tibial insert, PS , #3, 9mm 2303-3031   Tibi
UKNEE Patella,small 2401-1010  UKNEE Patella,medium 2401-1020   UKNEE Patella,large 2401-1030   UKNEE Patella,X-large 2401-1040   UKNEE Onset Patella, 3 pegs, x-small  2403-1010    UKNEE Onset Patella, 3 pegs, small  2403-1020    UKNEE Onset Patella, 3 pegs, medium  2403-1030    UKNEE Onset Patella, 3 pegs, large  2403-1040    UKNEE Onset Patella, 3 pegs,X-large  2403-1050       Variety of hip and knee implants and instruments, multiple uses.
U2 Acetabular cup, Ti beads porous coated, 44mm  U2 Acetabular cup, Ti beads porous coated, 46mm   U2 Acetabular cup, Ti beads porous coated, 48mm   U2 Acetabular cup, Ti beads porous coated, 50mm   U2 Acetabular cup, Ti beads porous coated, 52mm   U2 Acetabular cup, Ti beads porous coated, 54mm   U2 Acetabular cup, Ti beads porous coated, 56mm   U2 Acetabular cup, Ti beads porous coated, 58mm   U2 Acetabular cup, Ti beads porous coated, 60mm   U2 Acetabular cup, Ti beads porous coated, 62mm   U2 Acetabular cup liner assembly, 10hooded,44mm   U2 Acetabular cup liner assembly, 10hooded,46mm   U2 Acetabular cup liner assembly, 10hooded,48mm   U2 Acetabular cup liner assembly, 10hooded,50mm   U2 Acetabular cup liner assembly, 10hooded,52mm   U2 Acetabular cup liner assembly, 10hooded,54mm   U2 Acetabular cup liner assembly, 10hooded,56mm   U2 Acetabular cup liner assembly, 10hooded,58mm   U2 Acetabular cup liner assembly, 10hooded,60mm   U2 Acetabular cup liner assembly, 10hooded,62mm      Variety of hip and knee implants and instruments, multiple uses.
Femoral head, standard, 26mm, +0mm  Femoral head,medium, 26mm,+3mm   Femoral head, long, 26mm, +6mm   Femoral head, X-long, 26mm, +9mm   Femoral head, 28mm, -3mm   Femoral head, 28mm, +0mm   Femoral head, 28mm, +5mm   Femoral head, 28mm, +10mm   Femoral head, 32mm, -3mm   Femoral head, 32mm, +0mm   Femoral head, 32mm, +5mm   Femoral head, 32mm, +10mm   Femoral head, 36mm, -3mm   Femoral head, 36mm, +0mm   Femoral head, 36mm, +5mm   Femoral head, 36mm, +10mm      Variety of hip and knee implants and instruments, multiple uses.
Bipolar Cap, ID26mm, OD42mm  Bipolar Cap, ID28mm, OD44mm   Bipolar Cap, ID28mm, OD46mm   Bipolar Cap, ID28mm, OD48mm   Bipolar Cap, ID28mm, OD50mm   Bipolar Cap, ID28mm, OD52mm   Bipolar Cap, ID28mm, OD54mm   Bipolar Cap, ID28mm, OD56mm
Co-Cr cancellous bone screw,15mm  Co-Cr cancellous bone screw,20mm   Co-Cr cancellous bone screw,25mm   Co-Cr cancellous bone screw,30mm   Co-Cr cancellous bone screw,35mm   Co-Cr cancellous bone screw,40mm      Variety of hip and knee implants and instruments, multiple uses.
Zweimueller Type Stem SCS-Standard Sz 01  Zweimueller Type Stem SCS-Standard Sz 00   Zweimueller Type Stem SCS-Standard Sz 1   Zweimueller Type Stem SCS-Standard Sz 2   Zweimueller Type Stem SCS-Standard Sz 3   Zweimueller Type Stem SCS-Standard Sz 4   Zweimueller Type Stem SCS-Standard Sz 5   Zweimueller Type Stem SCS-Standard Sz 6   Zweimueller Type Stem SCS-Standard Sz 7   Zweimueller Type Stem SCS-Standard Sz 8   Zweimueller Type Stem SCS-Standard Sz 9   Zweimueller Type Stem SCS-Standard Sz 10   Zweimueller Type Stem SCL-Lateralized Sz 3   Zweimueller Type Stem SCL-Lateralized Sz 4   Zweimueller Type Stem SCL-Lateralized Sz 5   Zweimueller Type Stem SCL-Lateralized Sz 6   Zweimueller Type Stem SCL-Lateralized Sz 7   Zweimueller Type Stem SCL-Lateralized Sz 8   Zweimueller Type Stem SCL-Lateralized Sz 9   Zweimueller Type Stem SCR-Revision Sz 3   Zweimueller Type Stem SCR-Revision Sz 4   Zweimueller Type Stem SCR-Revision Sz 5   Zweimueller Type Stem SCR-Revision Sz 6   Zweimueller Type Stem SCR-Revision Sz 7   Zweimueller Type Stem SCR-Revision Sz 8   Zweimueller Type Stem SCR-Revision Sz 9   Zweimueller Type Stem SCR-Revision Sz 10   Zweimueller Type Stem SCR-Revision Sz 11      Variety of hip and knee implants and instruments, multiple uses.
Ball Head, 28 Short CERAMIC  Ball Head, 28 Medium CERAMIC   Ball Head, 28 Long CERAMIC   Ball Head, 32 Short CERAMIC   Ball Head, 32 Medium CERAMIC   Ball Head, 32 Long CERAMIC   Ball Head, 28 Short CoCr   Ball Head, 28 Medium CoCr   Ball Head, 28 Long CoCr   Ball Head, 28 X-Long CoCr   Ball Head, 28 XX-Long CoCr   Ball Head, 32 Short   Ball Head, 32 Medium   Ball Head, 32 Long
Seasonale(R) (Levonorgestrel/Ethinyl Estradiol Tablets), 0.15 mg/0.03 mg, 3 extended-cycle tablet dispensers, 91 tablets each, Rx only, TEVA Women Health, Inc., Subsidiary of TEVA Pharmaceuticals USA, Inc., Sellersville, PA  NDC 51285-058-66
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) detected during impurity testing
Camrese(TM) (Levonorgestrel/Ethinyl Estradiol Tablets), 0.15 mg/0.03 mg and Ethinyl Estradiol 0.01 Tablets, 2 Extended-Cycle Tablet Dispensers (NDC 0093-3134-82) and 1 Extended-Cycle Tablet Dispenser NDC 0093-3134-91), 91 Tablets Each, Rx only, TEVA Womens Health Inc., Subsidiary of TEVA Pharmaceuticals, Inc., Sellersville, PA
Failed Impurity/Degradation Specifications; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) detected during impurity testing
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
Community Blood Bank of Lancaster County Medical Society
Blood product, which was collected from a donor who traveled to malarial endemic areas, was distributed.
Blood products, which were collected from a donor who traveled to malarial endemic areas, were distributed.
Blood Bank Of San Bernardino And Riverside Counties
Blood products, collected from a donor with a history of Hepatitis A, were distributed.
Worldwide Distribution-USA (nationwide) including DC and the states of OH, TX, IL, CA, GA, KY, FL, WI, NC, VA, WI, MN, MD, KS, OK, PA, OR ,HI, AZ, WA, TN, AR, IA, MI, CO, LA, NJ, IN, WV, MO, AL, NY, VT, and SC and the countries of France, Canada, Great Britain, Mexico, Australia, Sweden and Netherlands.
***REF S-3D*** 3mm Diamond Ball.     Used for cutting and shaping bone.
Due to three batches of product may have diamond grit size larger than intended applied to the head of the cutting burr.
Camila 0.35 mg Tablets, 6 cards of 28 pills, Dist. By: Physicians Total Care, Tulsa, OK --- NDC 54868-4814-0, MFG By TEVA Pharmaceuticals USA, Sellersville, PA
Physicians Total Care Lots: 6Z4C Exp. 10/31/2013
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
7th Heaven Bakeries Oatmeal Raisin Cookie, 7th Heaven Bakeries, Oklahoma City, OK
Ropinirole hydrochloride tablets, USP 4 mg, 100-count bottle (NDC 0378-5504-01), Rx only, Manufactured for:  Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A.  Made in India
Labeling: Label Error on Declared Strength- Unopened bottles of Ropinirole USP 3 mg tablets was found to be incorrectly labeled as Ropinirole USP 4 mg tablets..
Nora Apothecary and Alternative Therapies, Inc.
Bimix Inj 30 :1 Syr, 12x1.5 ml syr, 10x1.2 ml syr, 2x2 ml syr, 2x1 ml syr, 12x.05 ml syr  Penile Injection,30 and 90 day expiration,
All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Bimix Inj 30:0.5 MDV, 5 ml syr  Penile Injection, 90 day expiration,
Bimix Inj 30:1 MDV: 5ml, 10 ml, 3x10ml, 2x10ml  Penile Injection, 30 and 90 day expiration,
Papaverine Inj 30mg/ml Syr, 5mlsyr, 10mlsyr,10x0.95mlsyr  Penile Injection, 90 day expiration,
PGE-1 Inj 10mcg/ml MDV, 5ml  Penile Injection, 90 day expiration,
PGE-1 Inj 20mcg/ml MDV: 5ml, 7ml, 10ml, 20ml  Penile Injection, 90 day expiration,
PGE-1 Inj 30mcg/ml MDV, 7 ml  Penile Injection, 90 day expiration,
PGE-1 Inj 40mcg/ml MDV, 5 ml  Penile Injection, 90 day expiration,
Trimix Inj 30:1:10 MDV, 5 ml  Penile Injection, 30 and 90 day expiration,
Trimix Inj 30:1:20 MDV: 5 ml, 10 ml, 2x5 ml  Penile Injection, 30 and 90 day expiration,
Trimix Inj 30:1:40 MDV, 5 ml  Penile Injection, 30 and 90 day expiration,
Trimix Inj 30:3:5 MDV, 10ml  Penile Injection, 90 day expiration,
Trimix Inj 4.25ml Form MDV   Penile Injection, 90 day expiration,
Super Trimix #1 Inj MDV, 12 ml  Penile Injection, 90 day expiration,
Vancomycin Opth Soln 25mg/ml PF, 10ml  Opthalmic Soln, 10 day expiration,
Vancomycin Opth Soln 30mg/ml PRES, 10ml  Opthalmic Soln, 30 day expiration,
Vancomycin Opth Soln14mg/ml PF, 10ml  Opthalmic Soln, 30 day expiration,
Tobramycin Opth Soln 14mg/ml, 7ml  Opthalmic Soln, 10 day expiration,
Tobramycin Opth Soln 13mg/ml, 7ml  Opthalmic Soln, 10 day expiration,
Chlorhexidine Opth Soln 0.02%, 10 ml  Opthalmic Soln, 30 day expiration,
Dexamethasone Opth Soln 0.1% PF, 10 ml  Opthalmic Soln, 30 day expiration,
PHMB Opth Soln 0.02%, 10 ml  Opthalmic Soln, 30 day expiration,
Folic Acid Inj 5mg/ml MDV, 10 ml  Subcutaneous, 90 day expiration,
HCG Inj 1000un/ml MDV: 4ml, 8 ml  Subcutaneous, 30 day expiration,
HCG Inj 1200un/ml MDV, 10 ml  Subcutaneous, 30 day expiration,
HCG Inj 1250 un/ml MDV, 4 ml  Subcutaneous, 30 day expiration,
HCG Inj 500un/ml MDV, 5 ml  Subcutaneous, 30 day expiration,
Hydroxycobalamin Inj 1000mcg/ml MDV: 10 ml, 15 ml, 20 ml, 30 ml  Subcutaneous, 90 day expiration,
Hydroxycobalamin Inj  1 mcg/ml MDV, 2x30ml  Subcutaneous, 90 day expiration,
Hydroxycobalamin Inj 2500 mcg/ml MDV, 2x30ml  Subcutaneous, 90 day expiration,
Methylcobalamin Inj 1mg/ml MDV, 10 ml, 15 ml, 20 ml, 30 ml, 4x30 ml  Subcutaneous, 90 day expiration,
Methylcobalamin Inj 5mg/ml MDV: 5 ml, 10 ml, 12 ml, 20 ml  Subcutaneous, 90 day expiration,
Methylcobalamin 5mg/ml Inj Syr, 10x0.4syr   Subcutaneous, 90 day expiration,
Methylcobalamin Inj 2.5mg/ml MDV, 10 ml   Subcutaneous, 90 day expiration,
Methylcobalamin Inj 25mg/ml Syr: 8x0.06mlsyr, 10x0.06 ml syr, 12x0.06 ml syr      Subcutaneous, 30 and 90 day expiration,
Hydroxyprogesterone Inj 250mg/ml MDV, 5 ml  Intramuscular, 30 day expiration,
Renacidin Irrigation: 1000 ml,1120ml   Bladder Irrigation, 30 day expiration,
Gentamicin 24mg/60ml Irrigation, 15x60ml Syr   Irrigation, 14 day expiration,
Glutathione 200mg/ml Inj SDV: 3x50ml   14 day expiration, 1x50ml 21 day expiration
M.I.C.+B12 Inj MDV: 3x50ml, 4x50 ml  90 day expiration,
Lidocaine 2% Inj MDV, 20 ml   30 day expiration,
Meperidine 100mg/ml MDV, 5ml  90 day expiration,
Pyridoxine 100mg/ml Inj MDV, 1X30 ml  30 day expiration,
QuietCare-Networked.     Intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community.
Customers at 4 facilities reported receiving duplicate alerts using the QuietCare-Networked product.
QuietCare.     Intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community.
NEXGEN Complete Knee Solution Monoblock Tibial Drill with stop 10.7 mm.      Used to prepare cylindrical holes in the native tibia.
Zimmer is initiating a lot specific recall of the Trabecular Metal'' Tibia Stop Drill due to the potential of the outside diameter being oversized. As a result, there is a potential for the drill to not pass through the applicable drill guide.
Alere'' hCG Combo Cassette (20/10 mIU/mL) Kit.        Product Usage:  The AlereTM hCG Combo (20/10 mIU/mL) test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine, as an aid in the early detection of pregnancy. It is for healthcare professionals only.
Lot/Unit Codes: hCG1110133 & hCG1110135     Part Number: 92215      Expiration date, or Expected shelf life: 9/30/13 & 10/31/13
The firm initiated recall of Alere'' hCG Combo Cassette (20/10 mIU/mL) kit PN 92215, lots hCG1110133 and hCG1110135, because an investigation has indicated a portion of these Alere'' hCG Combo Cassette (20/10 mIU/mL) PN 92215 kit lots were incorrectly packaged with the Alere'' hCG Cassette (20 mIU/mL) PN 92210 Product Insert. The Alere'' hCG Cassette (20 mIU/mL) Product Insert contains information for hCG urine testing but lacks information for performing the hCG serum testing using the Alere'' hCG Combo Cassette product.
USA Nationwide including the states of CA, FL, IL, MD, MA, NJ, NY, NC, ND, OH, OR, PA, TN, TX, VA, WA, DC and Puerto Rico
Integrity 3.0     Product Usage:   The Agility multileaf collimator is indicated for use when additional flexibility is required in conforming the radiation beam to the anatomy to be exposed.
Unexpected movement during beam delivery may not be detected if there are incorrect static tolerances for Linac Geometric Axes loaded in Integrity R3.0.
Worldwide Distribution - USA Nationwide including Puerto Rico and countries of: UK, CHL, ENG, BEL, ITA, TKY, BEL, LIT, LTV, EGY, SPG, HOK, SWE, MEX, UAE, COR, ISR,  MAL, AUS, POR, POL, SLN and STQ.
PTS PANELS, Glucose Test Strips for use with CardioChek Brand Analyzers     Product Usage:  used by healthcare professionals and individuals with diabetes to measure glucose in whole blood
Internal investigation demonstrated under-recovery for glucose when tested against a reference method.  This could result in a low to moderate health risk.
Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AL, AZ, CA, CO, CT, FL, IL, IN, IO, GA, KS, KY, LA, MD, MN, MS, MO, NK, NV, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN , TX, VT, VA, WA, and WV, and  the countries of Guatemala, Poland, Panama, and United Kingdom.
EZ Breathe Atomizer  Model # EZ-100.     For the delivery of liquid medications for respiratory usage.
Possible dislodgement of the ''Plate A'', if this instance occurs, it presents a potential choking hazard.
Asthmanefrin Starter Kit contains ten (10) Asthmanefrin vials and one (1) EZ Breathe Atomizer.     For the delivery of liquid medications for respiratory usage.
EZ Breathe Medication Cup.     For the delivery of liquid medications for respiratory usage.
Lisinopril Tablets, USP, 30 mg, Rx only, 100 tablets, NDC 65862-041-01 Manufactured for: Aurobindo Pharma USA Inc. 2400 Route 130 North, Dayton, NJ 08810  Manufactured by: Aurobindo Pharma Limited Hyderabad- 500 072 India
Labeling: Label Error on Declared Strength: Incorrect strength on side display panel of label
Thyroidectomy Indication for the da Vinci Surgical Systems;     Product Usage:   da Vinci Thyroidectomy offers a minimally invasive surgery for both partial and total thyroidectomy procedures, including endoscopic and video assisted procedure that are preferable to conventional (open) procedures that utilize a cervical incision because they leave no visible neck scar.
Promotional literature for use of the da Vinci system for thyroidectomy, which had not been approved with a change to the 510(k).
Worldwide distribution - USA Nationwide and the countries of  Australia, Austria, Belgium, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, New Zealand, Norway, Pakistan, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom.
Tip Cover Accessory, 8 MM, MCS, box of 10     Product Usage:   The disposable Tip cover accessory is used in conjunction with the 8mm Monopolar Curved Scissors Instruments to cut and coagulate tissue. The tip cover is intended to provide electrical insulation over a section of the Monopolar Curved Scissors instrument so that FR energy is only available at the scissors blades.
Clarification of existing labeling and related cautions for the tip cover accessory of the da Vinci Surgical System.
Meijer stores (201) located in Illinois, Indiana, Kentucky, Michigan, and Ohio may have received product from Meijer distribution centers.
Meijer Diced Pears in Fruit Juice 8oz cup
UPC: 71373337044 and All lots produced from November 29, 2012 through January 2, 2013.
Meijer Diced Pears in Fruit Juice, Meijer Diced Peaches in Fruit Juice, and  Meijer Mandarin Oranges in Fruit Juice 8 oz (226g) labels were developed, the Serving Size was updated to 1 cup (226g) but  the nutrition facts still reflect the 4 oz (113g) information.
Meijer Diced Peaches in Fruit Juice 8oz cup
UPC: 71373337017 and All lots produced from November 29, 2012 through January 2, 2013.
Meijer Mandarin Oranges in Fruit Juice  8oz cup
UPC: 88692601216 and All lots produced from November 29, 2012 through January 2, 2013.
Worldwide Distribution - USA Nationwide and countries of: Australia, Japan, Korea, Singapore and United Kingdom.
Canon Full Auto Ref-Keratometer RK-F2, Catalog Number 6937B002AA.     Product Usage:  This device is intended to be used to measure the refractive power and the radius of corneal curvature of the human eye.
Catalog Number 6937B002AA.  All serial numbers from the first unit onward.
Canon Inc. had received 17 claims from our foreign  sales companies between October to November   2012 that measurement value of RK-F2s refractive   power (SPH value) sometimes indicated abnormal   value which occurs approximately 5% in probability.
Worldwide Distribution- USA Nationwide and countries of: Argentina, Australia,Canada, Chile, China, Czech Republic, Egypt, India, Israel, Italy,Korea-Republic of, Poland, Qatar, Romania, Saudi Arabia, Singapore, Spain, Thailand, Turkey, and Venezuela.
Cannula 8MM Regular.     Provides the means of introduction and placement of an instrument or accessory into the human body.
Clarification of existing labeling information and operating procedures.
Flush Port (used in almost all da Vinci instruments)     Assists in cleaning the instrument.
da Vinci Si Surgeon Console.     Intended to assist in the accurate Control of Intuitive Surgical Endoscopic Instruments.
Worldwide Distribution - USA including AL, GA, MI, MN, NC, ND, OH, PA, SD, VA, VT, OH, TX, MA,  and Internationally to Korea.
Heart Sync C100-Physio Radiotransparent Defibrillation Electrodes Monophasic or biphasic compatible pacing/ cardioversion Defibrillation /ECG Monitoring electrodes     Used in connection with a defibrillator to deliver an electrical current (shock) to the patient's heart during cardiac emergencies.
On 4/18/13 HEARTSYNC became aware of a recall from their wire/connector sub-assembly supplier which is used in the C100-Physio Electrodes. There were reports of equipment damage due to misalignment from tooling installed in August 2012. The result of this damage could render the device incapable of delivering the appropriate energy or shock to the patient.
Vermed, Inc Radiotransparent Defibrillation Electrodes  Monophasic or biphasic compatible defibrillation/cardioversion/pacing/ECG Monitoring electrodes.      Used in connection with a defibrillator to deliver an electrical current (shock) to the patient's heart during cardiac emergencies.
Worldwide Distribution - USA Nationwide and tthe countries of Australia, Canada, Europe, Hong Kong, Mexico, New Zealand, Singapore, and Taiwan.
BBL DrySlide PYR Kit, catalog number 231747     Product Usage:   Presumptive diagnostic aid for group A streptococci and group D enterococci bacteria.
PYR kit - lot 2276481 with expiration date 09/30/13
In-vitro diagnostic agents were placed into incorrect packaging for distribution to microbiological laboratories.
BBL DrySlide Oxidase Kit, catalog number 231746     Product Usage:   Presumptive diagnostic aid for gram-negative bacteria.
Oxidase kit - lot 2222008 with expiration date 08/31/13
User Manual  addendum, TORS for da Vinci Surgical System IS 1200, IS 2000 and IS 3000.     Product Usage:   The user manual for Transoral Surgery (TORS) provided information to update and replace the Indications for Use and Representative uses section and add the section Warnings for Transoral Otolaryngology Surgery.
Change to User Manual to remove one indication for use and amend warnings to emphasize restrictions for use.
Red Bone Alley Restaurant Wasabi All Natural Sauce for all Seafood & Chicken, Net Wt. 12 fl oz.  Distributed by:  Red Bone Alley Foods, LLC, 1903 W. Palmetto Street, Florence, SC 29501.  Clear Plastic (Pet) Ring Neck Round bottle with neck band with white screw top cap.  6/12oz bottles= 1 case.
Worldwide Distribution-USA Nationwide and countries of: AU, CA, DE, ES, GB, IT, PT,  and JP.
AU2700 Clinical Chemistry Analyzer  AU5400 Clinical Chemistry Analyzer      Perform automated analysis of serum, urine, and other body fluids, including whole blood.
Beckman Coulter is recalling AU2700/AU2700 Plus & AU5400 Clinical Chemistry Analyzers becuase it was determined that the tubing/joint connections associated with these MODs may leak concentrated detergent. Beckman Coulter has received complaints that the joint connecting the tubing appears to disintegrate over time, causing a leak.
USA Nationwide Distribution including the states of:  IL, GA, CA, NY OH, AZ, TX, NE, FL, PA, NC, WI, AL, IN, CO, MO, MT, NE, MA, VA, AK, IN, MI, NJ, MD, TN, CT, WA, MN
AngioDynamics Micro Introducer Kits under the following labeling:   1) AngioDynamics 4F Standard Micro-Introducer Kit, Sterile, Catalog Number: 06597005, 2) AngioDynamics 5F Standard Micro-Introducer Kit, Sterile,   Catalog number: 06597012; 3) AngioDynamics 4F Standard Micro-Introducer Kit, Sterile, Catalog Number: 06597013; 4) AngioDynamics 5F Standard Micro- Introducer Kit, Sterile, Catalog Number: 06597018;  and 5) AngioDynamics 4F Standard Micro-Introducer Kit, Sterile, Catalog Number: 06597019.  Product kits are individually wrapped in plastic, 10 units included per box.      Product Usage:   This device is intended to be used to measure the refractive power and the radius of corneal curvature of the human eye.
Corresponding Lot numbers: 1) 588918 (Expiration date 01/2016), 2) 588927 (Expiration date 12/2015), 3) 588915 (Expiration date 01/2016), 4) 588913 (Expiration date 12/2015) and  5) 588930 (Expiration date 01/2016).
Domestic(1,760 units): 1)260 units/26 boxes, 2)310 units/31 boxes,3)260 units/26 boxes,4)880 units/88 boxes,5)60 units/6 boxes,Foreign:10 units/1 box
AngioDynamics Inc., is recalling Micro Introducer Kits and VenaCure EVLT NeverTouch Procedure Kits, because the potential exists that the micro Introducer (sheath/dilator) packaged within the kit could be the incorrect French size.
AngioDynamics VenaCure EVLT NeverTouch-FRS PROCEDURE KIT under the following labeling:   1) Gold-Tipped Fiber 45cm Kit, Catalog Number: 11403301;  2)  Gold-Tipped Fiber 65cm Kit, Catalog Number: 11403302; 3)  Gold-Tipped Fiber 90cm Kit, Catalog Number: 11403304.      Product Usage:   This device is intended to be used to measure the refractive power and the radius of corneal curvature of the human eye.
Corresponding Lot numbers: 1) 588948,  2) 588495 and 3)588480.  Expiration date for these lot numbers: 12/2013.
Domestic Only: 1) 300 units, 2) 300 units, 3) 151 units.
AngioDynamics Inc., is recalling Micro Introducer Kits and VenaCure EVLT NeverTouch Procedure Kits, because the potential exists that the micro Introducer (sheath/dilator) packaged within the kit could be the wrong French size.
Worldwide distribution - USA (nationwide) and Chile.
adult defibrillation, cardioversion, pacing, monitoring Disposable Electrodes, Model P-211-M1 and P-214-M1.     Product Usage:   Used by trained professionals in hospitals, doctors offices, and Emergency Medical Services for adult low-energy defibrillation, transcutaneous pacing, cardioversion and monitoring.
US: 10,410 pieces; Outside US: 100 pieces
TZ Medical Inc is recalling its P-211-M1 and P-214-M1 Medtronic / Physio Control Compatible transparent defibrillation electrodes because it may contain a defective white wire on the connector assembly.     If a failure were to occur, the end user would be able to identify the failure by inspecting the white wire 1/4 inch from the Gray Medtronic / Physio adapter. The consignees will notice discoloration in the protective plastic jacket.
Talenti Roman Raspberry Sorbetto, 16fl oz, Crafted by Talenti, Marietta, GA 30062
Worldwide Distribution - USA including Connecticut, Florida, Massachusetts, Missouri, New York, Ohio, and foreign distribution to(Canada, Italy, Australia, Germany, Netherlands, and Switzerland.
RayStation Therapy Treatment Planning System, Model Numbers 2.0, 2.5, and 3.0; CLASSIFICATION NAME: System, Planning, Radiation Therapy Treatment.     RayStation is a software system designed for treatment planning and analysis of radiation therapy.
Software version and build numbers 2.0.0.15, 2.5.1.89, and 3.0.0.251 (to determine if the version used is affected, bring up the About box in the RayStation application and check the build number reported0.
Under some circumstances, imported CT, MR and PET images are offset from their true positions by one pixel in one or two directions.  Users must be aware of this information to avoid incorrect dose calculations during treatment planning.
Merit Medical PerfOrma Anglographic Catheter 5F Multipack     Product Usage:   Angiographic catheters are designed to be used for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures.
Merit Medical Systems is recalling various lots of Performa Cardiac Multipacks containing a JR4.0 catheter due to a slight variation in tip shape.
Leucadia Autolok'' Polyaxial Pedicle Screw System.     Intended to help provide correction, immobilization and stabilization of spinal segments.
Alphatec Spine initiated this medical device recall for the following reason: due to tolerancing, the flange of the Phygen Leucadia'' Autolok set screw may interfere with the top of the screw head prior to fully locking the rod. If this condition occurs, the polyaxial  screw head and rod may fail to provide a rigid construct under loading. To date there have been   no reports of patient injury, adverse events or complaints received for this issue.
Worldwide Distribution - US Nationwide and the countries of:   Germany, France, Bulgaria, India, Colombia, Tunisia, Saudi Arabia, Finland, Denmark, Brasil, Italy, Estonia, South Korea, Russia, Greece, Thailand, Israel, Poland, Turkey, Slovakia, Portugal, Switzerland, Hungary, Great Britain, Netherlands, China, Indonesia, Australia, Sweden, Spain, Iran, Singapore, Norway, Austria and Czech Republic.
Alpine Biomed ApS is recalling Natus neurology Dantec KEYPOINT.NET ver. 2.20 Software due to the presence of a software bug.
Worldwide Distribution-USA (nationwide) including the states of AL, CA, CO, FL, IL, KY, MI, MS, NJ, NY, PA, TX, UT, VA, WA, and WI, and the countries of Austria, Australia, Belgium, Canada, Czech Republic, Denmark, France, Germany, Italy, Netherlands, Norway, Qatar, Romania, Spain, Sweden, Switzerland, Taiwan, United Kingdom, Saudi Arabia, Singapore, and Venezuela.
8mm Precise Bipolar Forceps used in conjunction with the da Vinci S Surgical System, Model IS1200.     Multiple use electrosurgical endoscopic instruments.
Reports of dislodging of the Cautery Plug Insert from the Cautery Plug Riser,  preventing a bipolar cautery cable from being properly connected which results in loss of cautery function of Bipolar Instruments.
8mm Maryland Bipolar Forceps used in conjunction with the da Vinci S Surgical System, Model IS1200.     Multiple use electrosurgical endoscopic instruments.
8mm Fenestrated Bipolar Forceps used in conjunction with the da Vinci S Surgical System, Model IS1200.     Multiple use electrosurgical endoscopic instruments.
Michigan, Oregon, Colorado, and New Jersey
next by Nature brand DARK CHOCOLATE BANANAS, NET WT. 3 Oz. (85g),  UPC 8 17582 25600 4, Produced by Tropical Valley Foods
The product contains the undeclared allergens walnuts and milk.
GRATED 2/25 GRANA PADANO; Lot Code: 313701A01; Pack Size: 2/25#; Net Pounds: 50; PACK DATE: 05/18/13; ITEM#DGP03; arthur schuman inc, 40 new dutch lane fairfield nj 07004 U.S.A.; 937-227-0030 www.arthurschuman.com;
Product Code: ARG07146JP;   Lot No.: 311501A01
Grated Grana Padano Hard Italian Cheese was tested and found to be positive for Listeria monocytogenes.