Hazard Type
Sterility Issue Recalls
10,814 product recalls involving sterility issue. Search official CPSC, FDA, and USDA datasets for every recall issued due to this hazard.
10,814Total Recalls
297Critical
67933.1MUnits Affected
All Recalls
Every Sterility Issue Recall
Sorted by most recent. Click any recall for full details and safety information.
10,814 recalls
High RiskFDA
Baptist Health Medical Towers Pharmacy And Infusion Services
Vancomycin 500 mg in 250 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Injectable Drugs1 affectedApr 18, 2016
High RiskFDA
Baptist Health Medical Towers Pharmacy And Infusion Services
Clindamycin 900 mg in 100 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Injectable Drugs16 affectedApr 18, 2016
High RiskFDA
Baptist Health Medical Towers Pharmacy And Infusion Services
Deferoxamine 4 grams/NS 101 mL Cassette, FOR SUBCUTANEOUS USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Drugs3 affectedApr 18, 2016
High RiskFDA
Baptist Health Medical Towers Pharmacy And Infusion Services
Invanz 1 gram Add-Vantage in 100 mL 0.45% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Injectable Drugs24 affectedApr 18, 2016
High RiskFDA
Baptist Health Medical Towers Pharmacy And Infusion Services
Vancomycin 1 grams in 250 mL 0.9% NS bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Injectable Drugs2 affectedApr 18, 2016
High RiskFDA
Baptist Health Medical Towers Pharmacy And Infusion Services
Nafcillin 12 grams in 322 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Injectable Drugs11 affectedApr 18, 2016
High RiskFDA
Baptist Health Medical Towers Pharmacy And Infusion Services
Dobutamine 2000 mcg/mL in a) D5W-500 mL, b) D5W-750 mL, c) D5W-1000 mL, d) D5W-1750 mL Bags, FOR IV USE ONLY, Baptist Health Medical Towe...
Injectable Drugs10 affectedApr 18, 2016
High RiskFDA
Baptist Health Medical Towers Pharmacy And Infusion Services
Ceftriaxone 2 gram in 100 mL 0.9% NS bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Injectable Drugs32 affectedApr 18, 2016
High RiskFDA
Baptist Health Medical Towers Pharmacy And Infusion Services
D5 1/2 NS 1000 mL with Electrolytes bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Injectable Drugs6 affectedApr 18, 2016
High RiskFDA
Baptist Health Medical Towers Pharmacy And Infusion Services
Deferoxamine 3300 mg/20 mL Sterile Water for Injection syringe, FOR SUBCUTANEOUS USE ONLY, Baptist Health Medical Towers Pharmacy & Infus...
Injectable Drugs5 affectedApr 18, 2016
High RiskFDA
Baptist Health Medical Towers Pharmacy And Infusion Services
Vancomycin 2 grams in 540 mL 0.9% NS bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Injectable Drugs11 affectedApr 18, 2016
High RiskFDA
Synthes (usa) Products Llc
3.2 mm Three-fluted drill bit, sterile, Catalog ID # 03.010.060S Product Usage: Usage: The 3.2 mm Three-fluted Drill Bits are instru...
Medical Devices7,363 affectedApr 18, 2016
High RiskFDA
Zimmer Trabecular Metal Technology, Inc.
TM LPS TIB SZ 3 C/D, 10MM - 00588605310 TM LPS TIB SZ 3 C/D, 12MM - 00588605312 TM LPS TIB SZ 3 C/D, 14MM - 00588605314 TM LPS T...
Medical Devices19,884 affectedApr 15, 2016
High RiskFDA
Zimmer Trabecular Metal Technology, Inc.
TM MONO TIB STR GRN SZ 5 - 00588606510 TM MONO TIB STR GRN SZ 5 12MM - 00588606512 TM MONO TIB STR GRN SZ 5 14MM - 00588606514 TM MON...
Medical Devices19,884 affectedApr 15, 2016
High RiskFDA
Zimmer Trabecular Metal Technology, Inc.
TM CR TIB SZ 3 C-H, 10MM- 00588604310 TM CR TIB SZ 3 C-H, 12 mm - 00588604312 TM CR TIB SZ 3 C-H, 14MM - 00588604314 TM CR TIB...
Medical Devices19,884 affectedApr 15, 2016
High RiskFDA
Ceg Enterprises Llc
Germ Terminator, Toothbrush Steam Sterilization for Oral Health. Model GT100. The Germ Terminator uses steam heat to sanitize two manua...
Medical Devices100,548 affectedApr 5, 2016
High RiskFDA
Synthes (usa) Products Llc
5.0 mm Periprosthetic Locking Screw Self-tapping 12 mm Sterile; Catalog ID # 02.221.462S Indicated for fixation of various long bones.
Medical Implants15 affectedApr 4, 2016
CriticalFDA
Complete Pharmacy And Medical Solutions Llc
Human Chorionic Gonadotropin, 15,000 IU per vial, lyophilized for injection, Rx only, Complete Pharmacy & Medical Solutions, Miami Lakes...
Injectable Drugs49 affectedApr 2, 2016
High RiskFDA
Biomet, Inc.
Various trauma and sports medicine instruments and implants. Rod, fixation, intramedullary and accessories.
Medical Implants0 affectedApr 1, 2016
High RiskFDA
Biomet, Inc.
Various trauma and sports medicine instruments and implants. Spinal interlaminal fixation orthosis.
Medical Implants0 affectedApr 1, 2016
High RiskFDA
Biomet, Inc.
Various trauma and sports medicine instruments and implants. Screw, fixation, bone.
Medical Implants0 affectedApr 1, 2016
High RiskFDA
Biomet, Inc.
Various trauma and sports medicine instruments and implants. Arthroscope.
Medical Implants0 affectedApr 1, 2016
High RiskFDA
Biomet, Inc.
Various trauma and sports medicine instruments and implants. Orthopedic manual surgical instrument.
Medical Implants0 affectedApr 1, 2016
High RiskFDA
Biomet, Inc.
Various trauma and sports medicine instruments and implants. cannula, surgical, general & plastic surgery and accessories
Medical Implants0 affectedApr 1, 2016
High RiskFDA
Biomet, Inc.
Various trauma and sports medicine instruments and implants. Reamer.
Medical Implants0 affectedApr 1, 2016
High RiskFDA
Biomet, Inc.
Various trauma and sports medicine instruments and implants. Plate, fixation, bone.
Medical Implants0 affectedApr 1, 2016
High RiskFDA
Biomet, Inc.
Various trauma and sports medicine instruments and implants. Fastener, fixation, nondegradable, soft tissue.
Medical Implants0 affectedApr 1, 2016
High RiskFDA
American Surgical Company
American Surgical Cotton Balls-Strung 1/2" Ref Number: 30-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices182 affectedMar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Policot 1/2" x 1/2" Ref Number: 90-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices5 affectedMar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Ultracot 15 mm x 15 mm (Glassine) Ref Number: 23-12G Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices6 affectedMar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Ray-Cot 1/2" x 3" Ref Number: 60-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices449 affectedMar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Ultracot 70 mm x 10090 mm Ref Number: 23-24 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices27 affectedMar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Americot Blue 1/2" x 1/2" Ref Number: 20-04S Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices262 affectedMar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Americot Blue 3/8" x 2" Ref Number: 20-26S Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices15 affectedMar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Uniqcot 1/2" x 1/2" Ref Number: 67-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices7 affectedMar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Ultracot 5 mm x 13 mm (Glassine) Ref Number: 23-02G Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices15 affectedMar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Ultracot 10 mm x 13 mm (Glassine) Ref Number: 23-03G Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices41 affectedMar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Delicot X 9 mm x 50 mm Ref Number: 63x07 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices1 affectedMar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Delicot 10 mm x 13 mm Ref Number: 63-03 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices442 affectedMar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Delicot non-xray 10 mm x 13 mm Ref Number: 63-03 non-xray Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices4 affectedMar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Americot Blue 1/4" x 1.5" Ref Number: 20-30S Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices22 affectedMar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Americot Blue 1" x 3" Ref Number: 20-10S Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices103 affectedMar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Delicot non-xray 5 mm x 13 mm Ref Number: 63-02 non-xray Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices21 affectedMar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Telfa 3/8" x 3" Ref Number: 80-05 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices11 affectedMar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Delicot 6 mm x 50 mm Ref Number: 63-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices113 affectedMar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Telfa 3/4" x 3" Ref Number: 80-11 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices7 affectedMar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Uniqcot 1/4" x 1/4" Ref Number: 67-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices39 affectedMar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Delicot 5 mm x 8 mm Ref Number: 63-01 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices287 affectedMar 31, 2016