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
Mederi Therapeutics, Inc
Mederi Stretta Catheter and Accessory Kit, Sterile For Use with the MEDERI MDRF1 GENERATOR ONLY. Used in the treatment of gastroesopha...
Surgical Devices·1,458 affected·Apr 3, 2017
High RiskFDA
Breg Inc
Dressing Shldr XL, P/N 04918 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care...
Medical Devices·2,609 affected·Mar 30, 2017
High RiskFDA
Breg Inc
Dressing M/U XL, P/N 02344 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care c...
Medical Devices·2,609 affected·Mar 30, 2017
High RiskFDA
Breg Inc
Dressing, Knee L/XL, P/N 04708 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Ca...
Medical Devices·2,609 affected·Mar 30, 2017
High RiskFDA
Breg Inc
Dressing Back, P/N 09810 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care col...
Medical Devices·2,609 affected·Mar 30, 2017
High RiskFDA
Breg Inc
Dressing Knee/Shldr, P/N 02328 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Ca...
Medical Devices·0 affected·Mar 30, 2017
High RiskFDA
Breg Inc
Dressing Shldr, P/N 04908 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care co...
Medical Devices·2,609 affected·Mar 30, 2017
High RiskFDA
Breg Inc
Dressing Rect L, P/N 02428 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care c...
Medical Devices·2,609 affected·Mar 30, 2017
High RiskFDA
Arrow International Inc
Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The ArrowEVOLUTIONTM Pressure Injectable P1CC with Chlorag+ard An...
Surgical Devices·43,394 affected·Mar 20, 2017
High RiskFDA
Akorn, Inc.
LATANOPROST OPHTHALMIC SOLUTION, 0.005%, 125 ug/2.5 mL, packaged in 2.5 mL bottle, Rx only, Manufactured for: Akorn, Inc., Lake Forest,...
Ophthalmic Drugs·107,940 affected·Mar 17, 2017
High RiskFDA
Smiths Medical Asd Inc.
CADD¿ Administration Set, 21-7339-24, Rx Only, Sterile EO.
Medical Devices·38,415 affected·Mar 17, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
Cataract Pack, part numbers 008886-1, AMS2806, PSS3442, PSS3442(A, WAL1155, and WAL1155(A. Product packaged in a convenient manner for u...
Medical Devices·7,508 affected·Mar 16, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
Dicken Eye Pack, part number CPA-3202-2. Product packaged in a convenient manner for use in a general clinical procedure
Medical Devices·172 affected·Mar 16, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
PRK Tray, part number DDS1044 Product packaged in a convenient manner for use in a general clinical procedure
Medical Devices·20 affected·Mar 16, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
Vitrectomy Kit, part number CMP1016(A. Product packaged in a convenient manner for use in a general clinical procedure
Medical Devices·440 affected·Mar 16, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
Ophthalmic Pack, Part number WAL1107(A and WAL1190 Product packaged in a convenient manner for use in a general clinical procedure
Medical Devices·169 affected·Mar 16, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
Vitrectomy Pack, part number AMS4952 Product packaged in a convenient manner for use in a general clinical procedure
Medical Devices·100 affected·Mar 16, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
Setup Pack, part number AMS3112(A Product packaged in a convenient manner for use in a general clinical procedure
Medical Devices·500 affected·Mar 16, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
Dr. Wischmeier Pack, part numbers: AMS3509 and AMS3509(A Product packaged in a convenient manner for use in a general clinical procedure
Medical Devices·1,170 affected·Mar 16, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
Lasik Tray, part number DDS1045-2 Product packaged in a convenient manner for use in a general clinical procedure
Medical Devices·260 affected·Mar 16, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
ENT Pack, part number AMS2727 Product packaged in a convenient manner for use in a general clinical procedure
Medical Devices·16 affected·Mar 16, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
Cataract Kit - Dr. Slingsby, part number CMP1017(B. Product packaged in a convenient manner for use in a general clinical procedure
Medical Devices·990 affected·Mar 16, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
Cataract Kit, part numbers CAT1467AM and CAT1538(B. Product packaged in a convenient manner for use in a general clinical procedure
Medical Devices·4,065 affected·Mar 16, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
Eye Cataract Pack, part numbers AMS1359 and AMS1359-1 Product packaged in a convenient manner for use in a general clinical procedure
Medical Devices·1,520 affected·Mar 16, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
Minor Operation Kit, part number AMS1530 Product packaged in a convenient manner for use in a general clinical procedure
Medical Devices·700 affected·Mar 16, 2017
High RiskFDA
Measurement Specialties Inc
Measurement Specialties Reusable Temperature Probe Autoclavable. Sold as Esophageal/Rectal (Adult), Esophageal/Rectal (Pediatric), and S...
Medical Devices·6,076 affected·Mar 13, 2017
High RiskFDA
Smith & Nephew, Inc.
D-RAD, S.T. LOCKING SCREWS, T7, QTY: (1), STERILE R, in the following sizes: (a) 2.4MM X 10MM, RES 74692410 (b) 2.4MM X 12MM, RES 74692...
Medical Devices·197 affected·Mar 9, 2017
High RiskFDA
Centurion Medical Products Corporation
CUSTOM CADAVER KIT The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer; they are then placed ...
Medical Devices·540 affected·Mar 9, 2017
High RiskFDA
Smith & Nephew, Inc.
Peri-Loc(R) VLP 3.5 MM X 6 MM SELF-TAPPING CORTEX SCREW, QTY: (1), STERILE R, REF 71801306 Orthopedic
Medical Devices·1 affected·Mar 9, 2017
High RiskFDA
Smith & Nephew, Inc.
D-RAD, 1.8MM X 16MM, LOCKING PEG, QTY: (1), STERILE R, RES 74671816 Orthopedic
Medical Devices·19 affected·Mar 9, 2017
High RiskFDA
Smith & Nephew, Inc.
D-RAD, 2.4MMX 20MM, S.T. CORTEX SCREW, QTY: (1), STERILE R, RES 74682420 Orthopedic
Medical Devices·100 affected·Mar 9, 2017
High RiskFDA
Centurion Medical Products Corporation
OPHTHALMIC DRESSING TRAY The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer; they are then p...
Medical Devices·1,692 affected·Mar 9, 2017
High RiskFDA
Centurion Medical Products Corporation
OPHTHALMIC DRS TRAY The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer; they are then plac...
Medical Devices·588 affected·Mar 9, 2017
High RiskFDA
Biomet 3i, Llc
BIOMET 3i LTX DENTAL IMPLANTS Model LTX610 (6x10mm) - Plastic tray within Tyvek tray within cardboard box; one (1) unit per box. Labe...
Medical Implants·5 affected·Mar 8, 2017
High RiskFDA
Covidien Llc
Covidien Curity Wet Dressing 8 x 4 (20.3 cm x 10.2 cm), Sterile Item Code: 3337 Curity sodium chloride dressing is saturated in a 2...
Medical Devices·104,688 affected·Mar 3, 2017
High RiskFDA
Covidien Llc
Covidien Curity Eye Pad Item Code: 91650 The sterile eye pad is a device that consists of a pad made of various materials, such as gau...
Medical Devices·1,659,500 affected·Mar 3, 2017
High RiskFDA
Integra Lifesciences Corp.
Panta Nail, Rx only, Sterile,
Medical Devices·4,449 affected·Mar 3, 2017
High RiskFDA
Covidien Llc
Covidien Curity Eye Pad Item Code: 03201 The sterile eye pad is a device that consists of a pad made of various materials, such as gau...
Medical Devices·7,168,000 affected·Mar 3, 2017
High RiskFDA
Covidien Llc
Covidien Curity Saline Dressing 8' x 4 (20.3cm x10.2 cm), Sterile Item Code: 3606 Curity sodium chloride dressing is saturated in a 20...
Medical Devices·1,222,080 affected·Mar 3, 2017
High RiskFDA
Merit Medical Systems, Inc.
The PreludeSYNC Radial Compression Device is a sterile, single use disposable device used to assist in gaining and maintaining hemostasis...
Surgical Devices·1,940 affected·Mar 3, 2017
High RiskFDA
Inion Ltd.
Inion GRT Tack, drill bit and tack appl., 4x, Sterile. Is indicated for the surgical treatment of periodontal defects to aid in the r...
Medical Implants·36 affected·Mar 1, 2017
High RiskFDA
Zimmer Biomet, Inc.
Por fullct fem st 17x200mm, Sterile,
Medical Devices·9,867 affected·Feb 28, 2017
High RiskFDA
Zimmer Biomet, Inc.
Segmental fluted stem, 17x190mm str, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip ...
Medical Implants·9,867 affected·Feb 28, 2017
High RiskFDA
Conmed Corporation
HYFRECATOR 2000 HANDPIECE SHEATH, REF/Part Number 7-796-19, Rx ONLY, STERILE, Single Patient Use -- CONMED CORPORATION, 525 FRENCH ROAD U...
Surgical Devices·0 affected·Feb 28, 2017
High RiskFDA
Zimmer Biomet, Inc.
Fem IM Nail 14mmdx48cm left, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Medical Implants·9,867 affected·Feb 28, 2017
High RiskFDA
Zimmer Biomet, Inc.
Fem IM Nail 16mmdx38cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Medical Implants·9,867 affected·Feb 28, 2017
High RiskFDA
Zimmer Biomet, Inc.
Segmental malefemale taper, 220mm, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip an...
Medical Implants·9,867 affected·Feb 28, 2017
High RiskFDA
Zimmer Biomet, Inc.
Xl por st 24.0x220mm, bowed, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Medical Implants·9,867 affected·Feb 28, 2017