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.

76–100 of 2228

HighFDA (Devices)·Z-2507-2025·2025-09-10
MediHoney HCS sheet dressings recalled over packaging failures breaching sterility
MediHoney HCS Sheet Dressings, catalog numbers 31612, 31622 and 31644, are recalled after packaging failures were identified that could breach the sterile barrier. 3,583 units are affected.
Product
Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Sheet Dressing with Leptospermum Model/Catalog Number: 31612, 31622, 31644 Product Description: MEDIHONEY¿ HCS SHEET DRESSING with LEPTOSPERMUM HONEY is a moist wound dressing made of Leptospermum Honey (+15) in combination w
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2510-2025·2025-09-10
MediHoney hydrogel adhesive sheets recalled over sterile barrier packaging failures
MediHoney Hydrogel Adhesive Sheet dressings, catalog numbers 31722 and 31744, are recalled after packaging failures were identified that could breach the sterile barrier. 1,147 units are affected.
Product
Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Adhesive Sheet Model/Catalog Number: 31722, 31744 Product Description: MEDIHONEY¿ HCS ADHESIVE SHEET DRESSING with LEPTOSPERMUM HONEY is a moist wound dressing made of Leptospermum Honey (+15) in combination with a hydro
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2344-2025·2025-08-27
OtoLase starter kits recalled over potentially unsterilized product labeled as sterile
OtoLase Starter Kits, UPN AC-2003748, batches 32644549 and 32769567, are recalled because finished product labeled as sterile may not have been sterilized. 13 units are affected.
Product
OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablation, coagulation, incision, excision, and vaporization of soft tissue.
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2283-2025·2025-08-20
Kittner gauze rolls had biological foreign matter and wrong pack quantity
Carefree Surgical Specialties Robotic/Laparoscopy Kittner Rolls Gauze is being recalled for product contamination with biological foreign matter that could compromise sterility, and an incorrect quantity of gauze in sterile packaging.
Product
Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray Detectable 5/pk 25pk/CS Model/Catalog Number: 15505/25 Product Description: Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray Detectable 5/pk 25pk/
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2281-2025·2025-08-20
Kittner and tail gauze rolls had biological foreign matter inside packaging
Carefree Surgical Specialties Kittner + Tail Large roll gauzes are being recalled for product contamination with biological foreign matter that could compromise sterility, and an incorrect quantity of gauze in sterile packaging.
Product
Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner + Tail Large 4 Long X-Ray Detectable 5pk 25pk/CS Roll Gauzes Model/Catalog Number: 15508/25 Product Description: Robotic/Laparoscopy Kittner + Tail Large 4 Long X-Ray Detectable 5pk 25pk/CS R
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2282-2025·2025-08-20
Surgical gauze rolls recalled over biological foreign matter and miscounted packs
Carefree Surgical Specialties Robotic/Laparoscopy Kittner Rolls Gauze, catalog 15505/25 lot 1645, is recalled for biological foreign matter that could compromise sterility and for incorrect gauze counts. 500 units are affected.
Product
Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray Detectable 5/pk 25pk/CS Model/Catalog Number: 15505/25 Product Description: Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray Detectable 5/pk 25pk/
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2284-2025·2025-08-20
Kittner roll gauze with tail recalled over contamination and incorrect pack quantity
Carefree Surgical Specialties Kittner Roll Gauze + Tail, catalog 15506/25 lot 1607, is recalled for biological foreign matter that could compromise sterility and for incorrect gauze counts. 65 units are affected.
Product
Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Roll Gauze + Tail Medium 4 Long X-Ray Detectable 5pk 25pk/CS Roll Gauzes Model/Catalog Number: 15506/25 Product Description: Robotic/Laparoscopy Kittner Roll Gauze + Tail Medium 4 Long X-Ray
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0495-2025·2025-07-02
Azelastine Hydrochloride Ophthalmic Solution Recalled Due to Sterility
Apotex Corp. is recalling Azelastine Hydrochloride Ophthalmic Solution, USP 0.05% due to lack of assurance of sterility. The affected batch was distributed nationwide.
Product
AZELASTINE HYDROCHLORIDE — AZELASTINE HYDROCHLORIDE (AZELASTINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1995-2025·2025-07-02
Medline Umbilical Tray sterile packaging defect recall
Medline is recalling umbilical trays due to a possible packaging defect in the outer Tyvec pouch that protects the sterile product. The defect may compromise sterility.
Product
Medline UMBILICAL TRAY W/3.5&5FR CATH, REF UVT1250
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1875-2025·2025-06-04
Umbilical Vessel Catheter 5 French Triple Lumen Recall
Cardinal Health is recalling Umbilical Vessel Catheter 5 French triple lumen devices due to a packaging defect that may compromise sterility. Non-sterile catheters could lead to infection in neonates.
Product
Catalog No. 8888160648; Umbilical Vessel Catheter 5 French triple lumen
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1870-2025·2025-06-04
Cardinal Health Umbilical Vessel Catheter Insertion Tray Recall
Cardinal Health is recalling one lot of umbilical vessel catheter insertion trays due to a packaging defect that may compromise sterility. Use of a non-sterile product on neonates could lead to infection.
Product
Catalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5 and 5 French UVCs
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1873-2025·2025-06-04
Umbilical Vessel Catheter 5 French Single Lumen Packaging Defect Recall
Cardinal Health is recalling umbilical vessel catheters due to a packaging defect that may compromise sterility, risking infection in newborns if non-sterile products are used.
Product
Catalog No. 8888160341; Umbilical Vessel Catheter 5 French single lumen
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1880-2025·2025-06-04
Segmental Stem Components Recalled for Potential Tyvek Seal Breach
Onkos Surgical is recalling Segmental Stem components of the ELEOS Limb Salvage System due to potential breach of Tyvek seals. The defect could compromise sterility.
Product
Segmental Stem, Cemented, Bowed, 152MM, 1 EACH. Model Numbers: CB-11152-03M, CB-13152-03M, CB-15152-03M, CB-17152-03M. Component of ELEOS LIMB SALVAGE SYSTEM
Category
Medical Device
Distribution
18 states
ModerateFDA (Devices)·Z-1884-2025·2025-06-04
Male-Female Midsection components from ELEOS Segmental Limb Salvage System
Onkos Surgical is recalling Male-Female Midsection components used in the ELEOS Segmental Limb Salvage System due to potential for breach of Tyvek seals. The recall affects 99 units distributed across 18 states.
Product
Male-Female Midsection with the following sizes and model numbers. a. Male-Female Midsection, 40mm, 1 EACH; Model Number: 25001040E b. Male-Female Midsection, 50mm, 1 EACH; Model Number: 25001050E c. Male-Female Midsection, 60mm, 1 EACH; Model Number: 25001060E d. Mal
Category
Medical Device
Distribution
18 states
ModerateFDA (Devices)·Z-1765-2025·2025-05-21
Centurion Sterile Weitlaner Retractor recalled for packaging puncture risk
Medline Industries is recalling Centurion Sterile Weitlaner Retractors (2,100 units) due to potential puncture damage to sterile packaging. The defect could compromise the sterility of the surgical instrument.
Product
Centurion Sterile Weitlaner Retractor, Reorder: 67315
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1737-2025·2025-05-14
Introducer Kit-Tearaway MicroSlide Medical Device Recall
Galt Medical Corporation is recalling Introducer Kit-Tearaway MicroSlide devices used to introduce catheters into blood vessels due to a potential open seal in the sterile barrier packaging. The affected units may not maintain sterility, creating a risk of infection.
Product
Introducer Kit- Tearaway MicroSlide REF KIT-051-01, 00841268106130 INT-101-15, 00841268107380 These introducers are used for the procedures to introduce catheters and other intravascular devices into the coronary and peripheral vasculature of adult and pediatric patients of
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1731-2025·2025-05-14
GALT Centeze Catheter recalled due to potential sterile packaging seal failure
Galt Medical Corporation is recalling 2,881 GALT Centeze Catheters due to a potential open seal in the sterile barrier packaging. The open seal could compromise sterility of the device.
Product
GALT Centeze Catheter REF: DRC-002-05 DRC-002-06 The Centeze is intended for use in percutaneous fluid aspirations and small volume drainage procedures. For both adult and adolescent groups.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1734-2025·2025-05-14
GALT Guidewire SGW-051-07 Sterile Packaging Seal Defect Recall
Galt Medical Corporation is recalling GALT Guidewire model SGW-051-07 due to a potential open seal in the sterile barrier packaging. The defect may compromise the sterility of the device.
Product
GALT Guidewire REF SGW-051-07 Guidewires are intended for use in percutaneous procedures, to introduce and position catheters and other interventional devices within the Coronary and peripheral vasculature.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1711-2025·2025-05-07
Medline Wound Care and Laceration Procedure Kits Recalled for Leaking Bottles
Medline is recalling Sterile Water and Sterile 0.9% Normal Saline bottles in wound care and laceration procedure kits due to leaking at the peel-foil and bottle opening interface.
Product
Medline procedure kits, labeled as: 1) WOUND CARE TRAY, REF DYNDA1412A; 2) LACERATION TRAY, REF DYNDL1263A.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1705-2025·2025-05-07
Medline Sterile Water USP bottles recalled for leaking at peel-foil interface
Medline Sterile Water, USP 100mL bottles are being recalled because they leak at the interface between the peel-foil and bottle opening, posing a contamination risk.
Product
Medline Sterile Water, USP, 100mL, REF RDI30295
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1710-2025·2025-05-07
Medline Plastics Suture Tray recalled due to leaking sterile liquid bottles
Medline is recalling Plastics Suture Tray kits (Ref SUT13535) because the included Sterile Water and Sterile 0.9% Normal Saline bottles leak at the peel-foil and bottle opening interface.
Product
Medline procedure kits, labeled as: PLASTICS SUTURE TRAY, REF SUT13535
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1713-2025·2025-05-07
Medline Sterile Water and Saline Bottles Recalled for Leaking
Medline Industries is recalling Sterile Water and Sterile 0.9% Normal Saline bottles due to leaking at the peel-foil and bottle opening interface. The affected kits were distributed nationwide and internationally.
Product
Medline procedure kits, labeled as: OL OCULAR, REF DYNJ906183K
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0374-2025·2025-04-30
Rocuronium Bromide Syringes Recalled Due to Sterility Assurance Risk
Denver Solutions, LLC DBA Leiters Health is recalling Rocuronium Bromide 50 mg per 5mL syringes due to potential leaking or damage that may compromise sterility assurance.
Product
Rocuronium Bromide 50 mg per 5mL (10mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC: 71449-004-11
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1604-2025·2025-04-23
Medline Convenience Kits Recalled for Potential Breather Pouch Seal Defects
Medline is recalling select IV convenience kits due to potential open or weak seals on breather pouches used for packaging. The defective seals may compromise sterility of the medical devices.
Product
Medline Convenience kits used for various procedures: 1) IV PACK SOUTH, Model Number: DYNJ88422
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1596-2025·2025-04-23
Medline Rhinoplasty Pack kits recalled for potential breather pouch seal failures
Medline is recalling Rhinoplasty Pack convenience kits (Model DYNJ27333F) due to potential open or weak seals on breather pouches used to package the sterile kits.
Product
Medline Convenience kits used for various procedures: 1) RHINOPLASTY PACK, Model Number: DYNJ27333F
Category
Medical Device
Distribution
Distributed nationwide