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
Custom Healthcare Systems, Inc.
CHS Custom Convenience (1) 1231-150L GOWN, RAGLAN, LG, NONREINF (2) 1231-150XL GOWN, RAGLAN, XL, NONREINF (3) 1231-140XL GOWN, SPECI...
Medical Devices·72,832 affected·Aug 13, 2018
High RiskFDA
Custom Healthcare Systems, Inc.
CHS Custom Convenience Kit-SUTURE REMOVAL KIT (W.ADSON SERR)Product Number:UNC-9481B
Medical Devices·1,250 affected·Aug 13, 2018
High RiskFDA
Custom Healthcare Systems, Inc.
CHS Custom Convenience Kit-GENERAL UTILITY TRAY Product Number:S1528-02
Medical Devices·630 affected·Aug 13, 2018
High RiskFDA
Custom Healthcare Systems, Inc.
CHS Custom Convenience Kit- COBAN¿, LF (1"X5 YDS) Product Number:D5-14591
Medical Devices·150 affected·Aug 13, 2018
High RiskFDA
Custom Healthcare Systems, Inc.
CHS Custom Convenience Kit-MOSQUITO FORCEPS 5 STR Product Number:B9-18914
Surgical Devices·50 affected·Aug 13, 2018
High RiskFDA
Custom Healthcare Systems, Inc.
CHS Custom Convenience Kit-ROCHESTER PEAN, CURVED (8") Product Number:D36-16669
Medical Devices·50 affected·Aug 13, 2018
High RiskFDA
Custom Healthcare Systems, Inc.
CHS Custom Convenience Kit-SPECIALIST¿ CAST PADDING 3" X 4 YDS) Product Number:D4-324SCP
Medical Devices·30 affected·Aug 13, 2018
High RiskFDA
Custom Healthcare Systems, Inc.
CHS Custom Convenience Kit-LP NEEDLE, 22G X 1 Product Number:NC401000
Medical Devices·250 affected·Aug 13, 2018
High RiskFDA
Custom Healthcare Systems, Inc.
CHS Custom Convenience Kit- (1) DT SCATPAD, DBL. TAPE, 12.5 X 16.5 Product Number: SEPA 402 (2) SCATPAD, 11 X 34 Product Number...
Medical Devices·1 affected·Aug 13, 2018
High RiskFDA
Custom Healthcare Systems, Inc.
CHS Custom Convenience Kit-TOENAIL REMOVAL TRAY Product Number: (1) ZZ-0956; (2) ZZ-0685
Medical Devices·80 affected·Aug 13, 2018
High RiskFDA
A M Systems Inc
Disposable Smooth Interior Tubing Material: Polyethylene EVA copolymer. This tubing is supplied non-sterile P/N: 1024920 Rev. 01 L...
Respiratory Devices·610 affected·Aug 10, 2018
High RiskFDA
Besmed Health Business Corporation
Ambu Aura40 Standard, Reusable Laryngeal Mask Catalog Number: 340300000
Medical Devices·267 affected·Aug 9, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 130 11 mm x 340 mm, Item Number 814511340 Product Usage: Intended for the fixation of fractures
Medical Devices·24 affected·Aug 8, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 125 13 mm x 400 mm, Item Number 814313400 Product Usage: Intended for the fixation of fractures
Medical Devices·10 affected·Aug 8, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Left 125 13 mm x 260 mm, Item Number 814413260 Product Usage: Intended for the fixation of fractures
Medical Devices·16 affected·Aug 8, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 125 11 mm x 440 mm, Item Number 814311440 Product Usage: Intended for the fixation of fractures
Medical Devices·20 affected·Aug 8, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 125 11 mm x 460 mm, Item Number 814311460 Product Usage: Intended for the fixation of fractures
Medical Devices·18 affected·Aug 8, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 125 13 mm x 180 mm, Item Number 814313180 Product Usage: Intended for the fixation of fractures
Medical Devices·34 affected·Aug 8, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Left 130 11 mm x 360 mm, Item Number 814611360 Product Usage: Intended for the fixation of fractures
Medical Devices·14 affected·Aug 8, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Left 125 9 mm x 440 mm, Item Number 814409440 Product Usage: Intended for the fixation of fractures
Medical Devices·29 affected·Aug 8, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Left 125 11 mm x 360 mm, Item Number 814411360 Product Usage: Intended for the fixation of fractures
Medical Devices·68 affected·Aug 8, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 125 9 mm x 320 mm, Item Number 814309320 Product Usage: Intended for the fixation of fractures
Medical Devices·38 affected·Aug 8, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 125 9 mm x 360 mm, Item Number 814309360 Product Usage: Intended for the fixation of fractures
Medical Devices·24 affected·Aug 8, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 125 9 mm x 460 mm, Item Number 814311460 Product Usage: Intended for the fixation of fractures
Medical Devices·20 affected·Aug 8, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail 130 11 mm x 180 mm, Item Number 814511180 Product Usage: Intended for the fixation of fractures
Medical Devices·85 affected·Aug 8, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 130 13 mm x 360 mm, Item Number 814513360 Product Usage: Intended for the fixation of fractures
Medical Devices·50 affected·Aug 8, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Left 125 9 mm x 460 mm, Item Number 814409460 Product Usage: Intended for the fixation of fractures
Medical Devices·30 affected·Aug 8, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 125 9 mm x 260 mm, Item Number 814309260 Product Usage: Intended for the fixation of fractures
Medical Devices·24 affected·Aug 8, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 130 11 mm x 320 mm, Item Number 814511320 Product Usage: Intended for the fixation of fractures
Medical Devices·39 affected·Aug 8, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Left 125 13 mm x 360 mm, Item Number 814413360 Product Usage: Intended for the fixation of fractures
Medical Devices·32 affected·Aug 8, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 130 9 mm x 320 mm, Item Number 814509320 Product Usage: Intended for the fixation of fractures
Medical Devices·22 affected·Aug 8, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail 125 9 mm x 180 mm, Item Number 814309180 Product Usage: Intended for the fixation of fractures
Medical Devices·153 affected·Aug 8, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 125 11 mm x 380 mm, Item Number 814311380 Product Usage: Intended for the fixation of fractures
Medical Devices·20 affected·Aug 8, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 125 11 mm x 360 mm, Item Number 814311360 Product Usage: Intended for the fixation of fractures
Medical Devices·12 affected·Aug 8, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 125 11 mm x 340 mm, Item Number 814311340 Product Usage: Intended for the fixation of fractures
Medical Devices·27 affected·Aug 8, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 125 9 mm x 380 mm, Item Number 814309380 Product Usage: Intended for the fixation of fractures
Medical Devices·19 affected·Aug 8, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Left 125 11 mm x 320 mm, Item Number 814411320 Product Usage: Intended for the fixation of fractures
Medical Devices·15 affected·Aug 8, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Left 125 13 mm x 340 mm, Item Number 814413340 Product Usage: Intended for the fixation of fractures
Medical Devices·31 affected·Aug 8, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 125 13 mm x 440 mm, Item Number 814313440 Product Usage: Intended for the fixation of fractures
Medical Devices·25 affected·Aug 8, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Left 130 11 mm x 400 mm, Item Number 814611400 Product Usage: Intended for the fixation of fractures
Medical Devices·16 affected·Aug 8, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail 125 11mm x 180mm, Item Number 814311180 Product Usage: Intended for the fixation of fractures
Medical Devices·153 affected·Aug 8, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 130 11 mm x 400 mm, Item Number 814511400 Product Usage: Intended for the fixation of fractures
Medical Devices·20 affected·Aug 8, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 125 13 mm x 280 mm, Item Number 814313280 Product Usage: Intended for the fixation of fractures
Medical Devices·22 affected·Aug 8, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Left 130 11 mm x 380 mm, Item Number 814611380 Product Usage: Intended for the fixation of fractures
Medical Devices·41 affected·Aug 8, 2018
High RiskFDA
Implant Direct Sybron Manufacturing, Llc
ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Impl...
Medical Implants·158 affected·Aug 7, 2018
High RiskFDA
Pharmcore Inc.
Ipamorelin 3 mg Lyophilized 1 vial 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
Drugs·6 affected·Aug 2, 2018
High RiskFDA
Pharmcore Inc.
Human Chorionic Gonadotropin 6000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
Drugs·3,351 affected·Aug 2, 2018
High RiskFDA
Pharmcore Inc.
Human Chorionic Gonadotropin 20000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
Drugs·355 affected·Aug 2, 2018