Hazard

Sterility Compromise recalls

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

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.

101–125 of 328

HighFDA (Drugs)·D-0257-2025·2025-03-19
Sodium Chloride Injection Recalled for Potential Sterility Compromise
Nephron Sterile Compounding Center is recalling Sodium Chloride Injection 9% due to potential leakage at the IV bottle port, which could compromise sterility. Affected lots were distributed nationwide.
Product
Sodium Chloride Injection 9%, USP, 500 mL, Single-Dose IV Bottle, Rx Only, nephron, 503B outsourcing facility, West Columbia, SC 29172, NDC: 69374-334-50
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1014-2025·2025-01-29
Dressing Change Kits Recalled for Potential Package Sterility Compromise
Trinity Sterile is recalling Wolf-Pak Dressing Change Kits due to a potential hole in the package that could compromise the sterility of the medical kit. Lot #600022 (3,960 units) distributed nationwide.
Product
Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Cloth Border Tegaderm Dressing & 3mL CHG One Step Applicator CS/30 Model/Catalog Number: DC3080LF Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600022, 132 cases affected. Componen
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1015-2025·2025-01-29
Dressing Change Kit Recalled Due to Package Integrity Concern
Trinity Sterile is recalling Wolf-Pak Premium Dressing Change Kits due to potential holes in packaging that could compromise sterility. The recall affects 5,940 units distributed in Maryland, Pennsylvania, Tennessee, and Texas.
Product
Brand Name: Wolf-Pak Product Name: Premium Dressing Change Kit with GuardiVa & Statlock CS/30 Model/Catalog Number: DC5090LF Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600088, 198 cases affected. Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1012-2025·2025-01-29
Dressing change kits recalled due to packaging defect compromising sterility
Trinity Sterile is recalling Dressing Change Kits with ChloraPrep and HaloGUARD due to potential holes in the package that could compromise product sterility. The recall affects 1,980 units distributed across multiple states.
Product
Brand Name: IMed Products Product Name: Dressing Change Kit with ChloraPrep 3mL & HaloGUARD Model/Catalog Number: IM46062 Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600022, 66 cases affected. Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1016-2025·2025-01-29
Dressing Change Tray Recalled Due to Potential Package Sterility Compromise
Trinity Sterile's Dressing Change Tray (Model TM6180CP, Lot 600032) is recalled because of a potential hole in the package that could compromise sterility. The recall affects 280 units distributed across Maryland, Pennsylvania, Tennessee, and Texas.
Product
Brand Name: Tacy Medical, Inc. Product Name: Dressing Change Tray CS/20 Model/Catalog Number: TM6180CP Software Version: N/A Product Description: Dressing change tray, case of 20, lot #600032, 50 cases affected. Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1013-2025·2025-01-29
Wolf-Pak Dressing Change Kits Recalled Due to Package Defects
Trinity Sterile is recalling Wolf-Pak Dressing Change Kits (lot #600018) due to potential holes in the package that could compromise product sterility. The recall affects 1,980 units distributed in Maryland, Pennsylvania, Tennessee, and Texas.
Product
Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Transparent Dressing & 3mL CHG One Step Applicator CS/30 Model/Catalog Number: DC3077LF Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600018, 66 cases affected. Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0526-2025·2024-12-04
Karl Storz surgical instruments recalled for sterility barrier defect
Karl Storz Endoscopy has recalled 105 surgical instruments with holes in their sterility barriers. The defect may compromise product sterility; affected devices were distributed nationwide and internationally.
Product
4.5 x 180 mm REF 28208BKS Aggressive Cutter, sterile, 6x 3.5 x 70 mm REF 28206CBS Full Radius Resector, sterile, 6x 5.5 x 120 mm REF 28205NDS Aggr. Pro Line Shaver Blade, sterile, 6x 5.5 x 120 mm REF 20205FDS Round Burr, sterile, 6x 6.5 x 120 mm REF 28205HES, Aggressi
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0227-2025·2024-11-13
Elekta Disposable Biopsy Needles Recalled for Internal Debris Contamination
Elekta recalls disposable biopsy needles for the Leksell Stereotactic System due to microscopic stainless steel debris found inside the needles. 111 kits (666 needles) distributed across multiple U.S. states are affected.
Product
Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, Diameter / 14 Gauge, containing 6 inner boxes labeled REF 911761, Disposable Biopsy Needle Kit for Leksell Stereotactic System. Each inner box of REF 911761 contains a Tyvek bag labeled REF 912465,
Category
Medical Device
Distribution
11 states
HighFDA (Devices)·Z-0280-2025·2024-11-06
Surgical Screwdriver Battery Pack Recalled for Foreign Material Contamination
Pro-Dex Inc is recalling KLS Martin battery packs for surgical drivers distributed in Florida because the sterile packaging may contain Tyvek shavings that could compromise device sterility.
Product
KLS Martin Battery Pack, REF: KLS BP2 001, and KLS BP2 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver 2.0 surgical driver, REF: KLS-SD-2000
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-3260-2024·2024-10-02
Biodesign Recto-Vaginal Fistula Plug Recalled for Premature Expiration
Cook Biotech is recalling 8 units of Biodesign Recto-Vaginal Fistula Plug devices because they expire before the date printed on the label. The affected products may lose sterility if used after actual expiration.
Product
Biodesign Recto-Vaginal Fistula Plug RVP-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order Number (GPN): G46603
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3258-2024·2024-10-02
Biodesign Recto-Vaginal Fistula Plug expires before labeled expiration date
Cook Biotech is recalling 3 units of Biodesign Recto-Vaginal Fistula Plug RVP-0.2 because the devices expire prior to the expiration date printed on the labeling.
Product
Biodesign Recto-Vaginal Fistula Plug RVP-0.2 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order Number (GPN): G46601
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-3084-2024·2024-09-25
Baxter pharmaceutical compounding inlets recalled for particulate matter contamination
Baxter is recalling EXACTAMIX compounding device inlets due to particulate matter observed in sterile fluid pathways before use. Approximately 5.8 million units affected worldwide.
Product
Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175, for use in a pharmaceutical compounding device
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3097-2024·2024-09-18
Smith & Nephew Tendon Staples Recalled for Compromised Packaging Sterility
Smith & Nephew is recalling 2,961 units of ROTATION MEDICAL TENDON STAPLES due to improper outer foil pouch sealing that may compromise product sterility. No injuries have been reported.
Product
ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixation of prosthetic material to soft tissues. Product Number: 72205201
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2945-2024·2024-09-11
Heparin Gore Viabahn VBX Endoprosthesis Recalled for Packaging Defects
W L Gore & Associates is recalling Heparin Gore Viabahn VBX Balloon Expandable Endoprosthesis devices due to packaging defects that may compromise sterility assurance and heparin activity.
Product
Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BXB051501A BXB051502A BXB051901A BXB051902A BXB052901A BXB052902A BXB053901A BXB053902A BXB055901A BXB055902A BXB057901A BXB057902A BXB061501A BXB061502A BXB061
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2521-2024·2024-08-14
Surgical Convenience Kits Recalled for Potential Sterilization Failure
American Contract Systems is recalling three surgical convenience kits due to potential sterilization failure from insufficient aeration time during processing.
Product
American Contract Systems Extremity convenience kit, American Contract Systems Hand Pack convenience kit, and American Contract Systems Total Knee Pack convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2520-2024·2024-08-14
Medical Procedure Kit Recalled Over Potential Sterilization Compromise
American Contract Systems is recalling Special Procedure Pack convenience kits due to insufficient aeration time during sterilization, which may have compromised sterility. Distributed in California, Kansas, Maine, Minnesota, Missouri, Nebraska, and South Dakota.
Product
American Contract Systems Special Procedure Pack convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2517-2024·2024-08-14
American Contract Systems Hand Pack Convenience Kit Sterilization Failure
American Contract Systems is recalling Hand Pack convenience kits that may not be sterile due to insufficient aeration time during sterilization. Affected devices distributed in CA, KS, ME, MN, MO, NE, and SD may pose a safety risk.
Product
American Contract Systems Hand Pack convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2519-2024·2024-08-14
American Contract Systems surgical kits recalled for sterilization defect
American Contract Systems Laparoscopy and Lap Chole surgical kits are being recalled because insufficient aeration time after sterilization may have compromised their sterility. The kits were distributed in seven U.S. states.
Product
American Contract Systems Laparoscopy Litho Std Pack convenience kit and American Contract Systems Lap Chole convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2424-2024·2024-07-31
BD Nano 2nd Gen Pen Needles recalled for post-expiration distribution
Embecta Corp. is recalling BD Nano 2nd Gen Pen Needles that were distributed at or after their February 29, 2024 expiration date. Using expired needles cannot guarantee sterility and integrity.
Product
BD Nano 2nd Gen Pen Needles 32G X 4mm (5-count sample contained in Patient Counseling Sample Toolbox -Catalog 6484755/Lot Number: 3750144)-Sterile, single use devices designed for the parenteral administration of a drug from a cartridge contained in a drug pen injector Model/C
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0587-2024·2024-07-17
Dianeal Low Calcium Dialysis Solution Recall: Sterility Risk from Connector Leaks
Baxter Healthcare recalls 6,874 bags of Dianeal Low Calcium peritoneal dialysis solution due to potential leaks in the connector assembly that could compromise product sterility.
Product
DIANEAL LOW CALCIUM WITH DEXTROSE — DIANEAL LOW CALCIUM WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2261-2024·2024-07-10
Stryker Corporation Recalls Expired Sterile Surgical Cannula Devices
Stryker Corporation has recalled expired sterile cannula devices distributed nationwide. The devices were past their expiration date, potentially compromising sterility and device safety.
Product
This product is a single use sterile device that is used to direct the lesion to the targeted site. Each cannula contains a stylet that is removed once the cannula is placed. The electrode is then inserted into the cannula. Catalog Number: 0406-630-225
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2144-2024·2024-06-26
VICRYL Sutures recalled due to packaging defect compromising sterility
Ethicon recalls 341,532 units of VICRYL surgical sutures worldwide due to holes in primary packaging that compromise sterility and could result in infection.
Product
VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissues. PRODUCT CODE: J214H J218H J258H J268H J269H J327H J344H
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2146-2024·2024-06-26
PDS II Polydioxanone Sutures Recalled Due to Compromised Sterility
Ethicon is recalling 56,952 units of PDS II polydioxanone sutures distributed worldwide because a packaging defect resulted in compromised sterility, which could lead to infection. No illnesses have been reported.
Product
PDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in ophthalmic surgery. These sutures are particularly useful where the combination of an absorbable suture and extended wo
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2148-2024·2024-06-26
MONOCRYL Surgical Sutures Recalled for Packaging Sterility Defect
Ethicon recalls 306,000 MONOCRYL surgical sutures worldwide due to holes in primary packaging from a manufacturing defect that compromises sterility and could result in infection.
Product
MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated PRODUCT CODE: Y315H Y345H Y359H Y398H Y416H Y417H Y426H Y427H Y935H Y936H Y945H
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2145-2024·2024-06-26
FDA Recalls VICRYL Plus Antibacterial Sutures Due to Packaging Defect
Ethicon is recalling VICRYL Plus Antibacterial Sutures due to a packaging machine defect that created holes in the primary packaging, potentially compromising product sterility. Affected sutures may pose an infection risk.
Product
VICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, cardiovascular and neurological tissues. PRODUCT CODE: VCP196H VCP417H VCP602H VCP603H VCP662H VCPB259H VCPB94
Category
Medical Device
Distribution
Distributed nationwide