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
Customed, Inc
LAPAROTOMY PACK 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture...
Surgical Devices·243 affected·Jul 10, 2015
High RiskFDA
Customed, Inc
ORTHOPEDIC PACK BASIC 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healin...
Surgical Devices·90 affected·Jul 10, 2015
High RiskFDA
Customed, Inc
LAPAROSCOPY CHOLE 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture r...
Surgical Devices·0 affected·Jul 10, 2015
High RiskFDA
Customed, Inc
LAPAROSCOPY PACK 2/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, sutur...
Surgical Devices·32 affected·Jul 10, 2015
High RiskFDA
Customed, Inc
FOLEY CATHETER KIT II 18 FR 20/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound heal...
Surgical Devices·280 affected·Jul 10, 2015
High RiskFDA
Customed, Inc
PREMIUM LAPAROTOMY PK CUSTOMED 6/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound he...
Surgical Devices·508 affected·Jul 10, 2015
High RiskFDA
Customed, Inc
OBSTETRICAL SURGICAL PACK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound heal...
Surgical Devices·0 affected·Jul 10, 2015
High RiskFDA
Customed, Inc
KNEE ARTHROSCOPY PK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, sutu...
Surgical Devices·188 affected·Jul 10, 2015
High RiskFDA
Customed, Inc
GOWN SURG. POLY REINF. XL XLONG 40/CS CUSTOMED Used by medical staff to perform surgical procedures and patient care procedures such...
Surgical Devices·40 affected·Jul 10, 2015
High RiskFDA
Customed, Inc
HIP ORTHO. PACK 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture...
Surgical Devices·3 affected·Jul 10, 2015
High RiskFDA
Customed, Inc
DRESSING CHANGE CUSTOMED 50/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing...
Surgical Devices·1,050 affected·Jul 10, 2015
High RiskFDA
Customed, Inc
CESAREAN PACK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture remov...
Surgical Devices·525 affected·Jul 10, 2015
High RiskFDA
Customed, Inc
MAYO STAND COVER W/CSR WRAP 30/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound heali...
Surgical Devices·540 affected·Jul 10, 2015
High RiskFDA
Customed, Inc
C-SECTION SURGICAL PACK 2/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound heali...
Surgical Devices·874 affected·Jul 10, 2015
High RiskFDA
Customed, Inc
LAPAROTOMY BASIC PACK 10/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, s...
Surgical Devices·30 affected·Jul 10, 2015
High RiskFDA
Customed, Inc
EXTREMITY PACK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture r...
Surgical Devices·285 affected·Jul 10, 2015
High RiskFDA
Customed, Inc
O.B. PK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removal...
Surgical Devices·48 affected·Jul 10, 2015
High RiskFDA
Customed, Inc
ANGIOGRAPHY PACK CUSTOMED 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound heali...
Surgical Devices·1,128 affected·Jul 10, 2015
High RiskFDA
Customed, Inc
LAPAROSCOPY PK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture remo...
Surgical Devices·244 affected·Jul 10, 2015
High RiskFDA
Customed, Inc
FANFOLD DRAPE 44"X58 60/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing,...
Surgical Devices·3,180 affected·Jul 10, 2015
High RiskFDA
Customed, Inc
SHOULDER PACK (I) (2) 6/CS CUSTOMED Used by medical staff to perform surgical procedures and patient care procedures such as wound ...
Surgical Devices·12 affected·Jul 10, 2015
High RiskFDA
Customed, Inc
BASIC PACK W/OUT GOWN 11/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, s...
Surgical Devices·77 affected·Jul 10, 2015
High RiskFDA
Customed, Inc
CESAREAN PACK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture remov...
Surgical Devices·104 affected·Jul 10, 2015
High RiskFDA
Customed, Inc
MINOR LAPAROTOMY PK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture...
Surgical Devices·675 affected·Jul 10, 2015
High RiskFDA
Customed, Inc
URETHRAL CATHETER TRAY CUSTOMED 50/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound he...
Surgical Devices·5,500 affected·Jul 10, 2015
High RiskFDA
Customed, Inc
ENDOVENOUS CUSTOM PACK 5/CS CUSTOMED Used by medical staff to perform surgical procedures and patient care procedures such as wound he...
Surgical Devices·20 affected·Jul 10, 2015
High RiskFDA
Customed, Inc
UNIVERSAL PACK 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture r...
Surgical Devices·27 affected·Jul 10, 2015
High RiskFDA
Customed, Inc
CYSTO TUR PACK CUSTOMED 10/CS REV. C 10/13 NON STERILE Used by medical staff to perform surgical procedures and patient care procedures...
Surgical Devices·290 affected·Jul 10, 2015
High RiskFDA
Customed, Inc
GOWN IMPERVIOUS EXTRA LONG 24/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healin...
Surgical Devices·144 affected·Jul 10, 2015
High RiskFDA
Customed, Inc
NEURO SPINE PACK 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, sutur...
Surgical Devices·123 affected·Jul 10, 2015
High RiskFDA
Customed, Inc
FOLEY CATH KIT 16FR. W/FOLEY S SENSOR 20/CS Used by medical staff to perform surgical procedures and patient care procedures such as...
Surgical Devices·160 affected·Jul 10, 2015
High RiskFDA
Customed, Inc
LAPAROSCOPY-GYN SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, s...
Surgical Devices·84 affected·Jul 10, 2015
High RiskFDA
Customed, Inc
GAUZE SPONGE 4"X4" 16 PLY SOFT 1280/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound ...
Surgical Devices·19,328 affected·Jul 10, 2015
High RiskFDA
Customed, Inc
ARTHROSCOPY PACK 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, sutu...
Surgical Devices·45 affected·Jul 10, 2015
High RiskFDA
Customed, Inc
IRRIGATION TRAY W/BULB SYRINGE CUSTOMED 50/CS Used by medical staff to perform patient care procedures such as wound healing, suture rem...
Medical Devices·4,800 affected·Jul 10, 2015
High RiskFDA
Customed, Inc
TUMMY TUCK & BREAST PACK-RFMHI 6/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound...
Surgical Devices·24 affected·Jul 10, 2015
High RiskFDA
Customed, Inc
INCISION AND DRAINAGE TRAY 50/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound heal...
Surgical Devices·1,050 affected·Jul 10, 2015
High RiskFDA
Customed, Inc
SHOULDER ARTHROSCOPY PACK 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing,...
Surgical Devices·327 affected·Jul 10, 2015
High RiskFDA
Customed, Inc
GAUZE 2" X 2" PRODUCTION ONLY 1500PK/CS CUSTOMED Used by medical staff to perform surgical procedures and patient care procedures such...
Surgical Devices·162,000 affected·Jul 10, 2015
High RiskFDA
Customed, Inc
SHOULDER ARTHROSCOPY PACK 2/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healin...
Surgical Devices·10 affected·Jul 10, 2015
High RiskFDA
Customed, Inc
FEMORAL PACK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture rem...
Surgical Devices·320 affected·Jul 10, 2015
High RiskFDA
Customed, Inc
WOUND MANAG.TRAY 24/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture...
Surgical Devices·1,248 affected·Jul 10, 2015
High RiskFDA
Customed, Inc
SHOULDER PACK 6/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture remo...
Surgical Devices·413 affected·Jul 10, 2015
High RiskFDA
Customed, Inc
OPEN HEART TRAY 1/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture ...
Cardiac Devices·56 affected·Jul 10, 2015
High RiskFDA
Customed, Inc
LAPAROSCOPY PACK 6/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, sutu...
Surgical Devices·138 affected·Jul 10, 2015
High RiskFDA
Customed, Inc
ARTHROSCOPY PK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture rem...
Surgical Devices·320 affected·Jul 10, 2015
High RiskFDA
C.r. Bard, Inc.
Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 12 Fr, (30/box), Product Code 51612. Intermittent catheter.
Surgical Devices·91,140 affected·Jul 7, 2015
High RiskFDA
C.r. Bard, Inc.
Magic3 Hydrophilic-coated Female Intermittent Urinary Catheter 14 Fr in the Insertion Supply Kit, Product Code 51614S. Intermittent ca...
Surgical Devices·534,972 affected·Jul 7, 2015