Hazard

Sterility Compromise recalls

2,228 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 2,228
Critical: 3
Severe: 255
Most recent: 2026-08-19

Of the 2,228 sterility compromise recalls we have scored against our rubric, 3 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 255 (11%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all sterility compromise recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1051–1075 of 2228

HighFDA (Devices)·Z-2137-2017·2017-05-31
Cardinal Health Recalls Jackson-Pratt Hemaduct Silicone Round Drains
Cardinal Health is recalling Jackson-Pratt Hemaduct Silicone Round Drains because the product seal may be compromised, potentially compromising sterility and increasing the risk of infection.
Product
Jackson-Pratt Hemaduct Silicone Round Drain, 19FR W/15FR Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain i
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2136-2017·2017-05-31
Cardinal Health Recalls Jackson-Pratt Hemaduct Silicone Round Drains
Cardinal Health is recalling Jackson-Pratt Hemaduct Silicone Round Drains because the product seal may be compromised, potentially compromising sterility and increasing infection risk.
Product
Jackson-Pratt Hemaduct Silicone Round Drain, 19FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2050-2017·2017-05-17
Mederi Stretta Catheter Recalled Due to Sterility Compromise
Mederi Therapeutics is recalling 1,458 Stretta Catheter kits because a breach in the sterile barrier package compromised sterility.
Product
Mederi Stretta Catheter and Accessory Kit, Sterile For Use with the MEDERI MDRF1 GENERATOR ONLY. Used in the treatment of gastroesophageal reflux disease (GERD). REF 175-5580
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1837-2017·2017-04-26
Alcon Recalls Patient Care Kits Due to Sterile Packaging Concerns
Alcon is voluntarily removing 561,702 Patient Care Kits from the US market because the supplier reported potential sterile packaging compromise.
Product
Alcon Patient Care Kits Product Usage: A Patient Care Kit is an assemblage of single-use medical devices and accessories designed by medical professionals for specific procedures. The Patient Care kits are configured with customer-specific components
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1796-2017·2017-04-19
Windstone Medical Packaging Recalls Plastic Packs with Compromised Sterile Eye Pads
Windstone Medical Packaging is recalling 376 plastic kits containing Medtronic Curity Eye Pads because the sterile packaging may be compromised.
Product
Plastic Pack, part numbers AMS1028, AMS1028(A, and WAL1189. Product packaged in a convenient manner for use in a general clinical procedure
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1784-2017·2017-04-19
Windstone Medical Recalls Cataract Kits Due to Sterile Packaging Concerns
Windstone Medical Packaging is recalling 990 cataract kits because the sterile packaging of the included eye pads may be compromised.
Product
Cataract Kit - Dr. Slingsby, part number CMP1017(B. Product packaged in a convenient manner for use in a general clinical procedure
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1783-2017·2017-04-19
Windstone Medical Packaging Recalls Cataract Kits Due to Sterility Concerns
Windstone Medical Packaging is recalling 4,065 cataract kits because the sterile packaging of the included eye pads may be compromised.
Product
Cataract Kit, part numbers CAT1467AM and CAT1538(B. Product packaged in a convenient manner for use in a general clinical procedure
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1798-2017·2017-04-19
Windstone Medical Setup Packs Recalled for Potential Sterility Compromise
Windstone Medical Packaging is recalling 500 Setup Packs containing Medtronic Curity Eye Pads due to potential sterile packaging compromise.
Product
Setup Pack, part number AMS3112(A Product packaged in a convenient manner for use in a general clinical procedure
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1799-2017·2017-04-19
Windstone Medical Vitrectomy Kits Recalled for Sterile Packaging Compromise
Windstone Medical Packaging is recalling Vitrectomy Kits because the sterile packaging of the included Medtronic Curity Eye Pad may be compromised.
Product
Vitrectomy Kit, part number CMP1016(A. Product packaged in a convenient manner for use in a general clinical procedure
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1794-2017·2017-04-19
Windstone Medical Ophthalmic Packs Recalled for Sterile Packaging Compromise
Windstone Medical Packaging is recalling 169 ophthalmic packs containing Medtronic Curity Eye Pads because the sterile packaging may be compromised.
Product
Ophthalmic Pack, Part number WAL1107(A and WAL1190 Product packaged in a convenient manner for use in a general clinical procedure
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1786-2017·2017-04-19
Windstone Medical Recalls Custom Kits with Compromised Sterile Eye Pad Packaging
Windstone Medical Packaging is recalling 164 custom kits containing Medtronic Curity Eye Pads due to potential sterile packaging compromise.
Product
Custom Tray, part numbers PSS1111 and PSS1111(A. Product packaged in a convenient manner for use in a general clinical procedure
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1791-2017·2017-04-19
Windstone Medical Eye Pack Recall Due to Sterile Packaging Compromise
Windstone Medical Packaging is recalling 1,330 Eye Packs because the sterile packaging of the included eye pads may be compromised.
Product
Eye Pack, part numbers WAL1085(B and WAL1085(C\ Product packaged in a convenient manner for use in a general clinical procedure
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1817-2017·2017-04-19
Micromedics FibriJet Endoscopic Catheter Introducer Recalled for Packaging Seal Defects
Micromedics, Inc. is recalling 273 units of FibriJet Endoscopic Catheter Introducers because small channels in the sterile packaging seal may compromise package integrity and sterility assurance.
Product
Nordson Micromedics FibriJet Endoscopic Catheter Introducer, Catalog Number SA-3445. Sterilized using Ethylene Oxide
Category
Medical Device
Distribution
9 states
HighFDA (Devices)·Z-1788-2017·2017-04-19
Windstone Medical Recalls Dr. Wischmeier Packs Due to Sterility Concerns
Windstone Medical Packaging is recalling 1,170 Dr. Wischmeier Packs because the sterile packaging of the included eye pads may be compromised.
Product
Dr. Wischmeier Pack, part numbers: AMS3509 and AMS3509(A Product packaged in a convenient manner for use in a general clinical procedure
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1787-2017·2017-04-19
Windstone Medical Recalls Dicken Eye Packs Due to Sterility Concerns
Windstone Medical Packaging is recalling 172 Dicken Eye Packs because the sterile packaging of the eye pads may be compromised.
Product
Dicken Eye Pack, part number CPA-3202-2. Product packaged in a convenient manner for use in a general clinical procedure
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1795-2017·2017-04-19
Windstone Medical Recalls Ortho Basic Packs Due to Sterility Concerns
Windstone Medical Packaging is recalling 12 Ortho Basic Packs because the sterile packaging of the included eye pads may be compromised.
Product
Ortho Basic Pack, part number AMS6459 Product packaged in a convenient manner for use in a general clinical procedure
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1793-2017·2017-04-19
Windstone Medical Minor Operation Kit Recall Due to Sterile Packaging Concerns
Windstone Medical Packaging is recalling 700 Minor Operation Kits because the sterile packaging of the included Medtronic Curity Eye Pad may be compromised.
Product
Minor Operation Kit, part number AMS1530 Product packaged in a convenient manner for use in a general clinical procedure
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1745-2017·2017-04-12
Recall of Curity Saline Dressings Due to Compromised Sterility
Covidien LLC is recalling Curity Saline Dressings because the sterile barrier was breached, compromising sterility. The recall covers lots with expiration dates from February 2017 through November 2019.
Product
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% hypertonic saline solution. The dressing is designed to help promote biological cleansing within the wound and aid in the autolytic debrideme
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1744-2017·2017-04-12
Recall of Curity Sodium Chloride Dressings Due to Sterility Compromise
Covidien LLC is recalling Curity Sodium Chloride Dressings because the sterile barrier is breached, compromising sterility. The recall affects lots with expiration dates from February 2017 through November 2019.
Product
Covidien Curity Sodium Chloride Dressing , 6 x 6-3/4 (15.2 cm x 17.1 cm), Sterile Item Code: 3339 Curity Sodium Chloride Dressing is indicated for use on exudating and/or infected wounds
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1743-2017·2017-04-12
Sterile Saline Dressing Recalled Due to Compromised Sterility Barrier
FDA is recalling Kerlix Super Sponge Saline Dressings because the sterile barrier is breached, potentially compromising sterility.
Product
Covidien Kerlix Super Sponge Saline Dressing, Sterile Item Code: 3338 Curity sodium chloride dressing is saturated in a 20% hypertonic saline solution. The dressing is designed to help promote biological cleansing within the wound and aid in the autolytic debridement process.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1742-2017·2017-04-12
Recall of Sterile Wound Dressings Due to Compromised Sterility Barrier
Covidien is recalling Curity Wet Dressings because the sterile barrier was breached, potentially compromising sterility. The recall affects units distributed worldwide.
Product
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 20% hypertonic saline solution. The dressing is designed to help promote biological cleansing within the wound and aid in the autolytic debridem
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1740-2017·2017-04-12
Recall of Sterile Eye Pads Due to Compromised Sterility Barrier
Covidien LLC is recalling Curity Eye Pads because the sterile barrier was breached, potentially compromising sterility.
Product
Covidien Curity Eye Pad Oval, 1-5/8 x 2-5/8 (4.2 cm x 6.7 cm), Sterile Item Code: 2841 The sterile eye pad is a device that consists of a pad made of various materials, such as gauze and cotton, intended for use as a bandage over the eye for protection or absorption of secr
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1741-2017·2017-04-12
Recall of Sterile Eye Pads Due to Compromised Sterility Barrier
Covidien is recalling Curity Eye Pads because the sterile barrier was breached, potentially compromising sterility. The recall affects units distributed worldwide.
Product
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 gauze and cotton, intended for use as a bandage over the eye for protection or absorption of secretions. It is supplied sterile to allow for use i
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1669-2017·2017-04-05
Recall of Regard Sterile Custom Procedure Trays Due to Glove Splitting
Resource Optimization & Innovation LLC is recalling 32 kits of Regard sterile custom procedure trays because a light glove component can split during application, breaking the sterile field.
Product
Regard, Item Number: 800508004, Sterile, LD0586D - C Section - Jasper
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1667-2017·2017-04-05
Recall of Regard Sterile Procedure Trays Due to Splitting Glove Component
Resource Optimization & Innovation LLC is recalling 126 kits of Regard sterile procedure trays because a light glove component can split, breaking the sterile field.
Product
Regard, Item Number: 800508002, Sterile, LD0586B - C Section - Jasper
Category
Medical Device
Distribution
2 states