The Recall Desk

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.

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.

51–75 of 2228

  • HighFDA (Devices)·Z-1417-2026·2026-02-25

    Medline C-Section Surgical Kits Recalled Over Sterilization Calibration

    Medline is recalling 4,525 C-section convenience kits worldwide due to calibration issues with sterilization and packaging equipment that could affect sterility assurance.

    Product
    Medline Convenience Kits: 1) C-SECTION PACK, Model Number: CDS820080N; 2) C-SECTION CDS, Model Number: CDS983523G; 3) C-SECTION, Model Number: CDSCCR611O; 4) C-SECTION, Model Number: CDSCCR611P; 5) LUD C-SECTION-LF, Model Number: DYNJ0101616I; 6) C-SECTION TRAY, Model
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0939-2026·2025-12-31

    Ophthalmic surgical packs recalled over incomplete seals affecting sterility

    Alcon Research is recalling 151 Custom Pak ophthalmic procedure packs because the packs may have incomplete seals affecting sterility. The FDA has classified the action as Class I.

    Product
    Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Numbers: 9903-20, 17188-04, 19762-03, 19203-04, 19203-04, 17957-10 Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience k
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0921-2026·2025-12-24

    Sterile operating room scissors recalled over weak seals affecting sterility

    Medline is recalling 56 sterile operating room scissors because weak packaging seals may result in a breach of sterility and an increased risk of infection if the product is used.

    Product
    SCISSORS, OR, SHARP/BLUNT, 5.5", STERILE, Item Number DYND04000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0922-2026·2025-12-24

    Sterile Kelly forceps recalled over weak seals that may breach sterility

    Medline is recalling 53 sterile Kelly forceps because weak packaging seals may result in a breach of sterility and an increased risk of infection if the product is used.

    Product
    FORCEP, STD STR, STERILE KELLY, 5.5 IN, Item Number DYNJ04048
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0898-2026·2025-12-17

    Fabric bandages recalled over open package seals affecting product sterility

    Medline is recalling 182,526 CURAD Germ-Shield Touch-Free Fabric Bandages because packaging may exhibit open seals that could compromise the sterility of the product.

    Product
    CURAD Germ-Shield Touch-Free Fabric Bandages, Sterile, 0.75" x 3", 30/Box, Medline Item Number CUR1930F
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0900-2026·2025-12-17

    Quick Strip plastic bandages, three quarter inch, recalled over open seals

    Medline is recalling 1,725,600 Quick Strip Plastic Sterile Adhesive Bandages, 0.75" x 3", because packaging may exhibit open seals that could compromise the sterility of the product.

    Product
    Quick Strip Plastic Sterile Adhesive Bandages, 0.75" x 3", Medline Item Number NON25500QS
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0890-2026·2025-12-17

    Adhesive bandages recalled over open package seals that may compromise sterility

    Medline is recalling 1,566,500 Fur Friends Plastic Sterile Adhesive Bandages because packaging may exhibit open seals that could compromise the sterility of the product.

    Product
    Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L= 68 mm, Taper 10/12. Knee component of limb salvage replacement devices.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Food)·H-0268-2026·2025-12-17

    Curad Quick Strip fabric bandages recalled over compromised package seals

    Medline is recalling 18,000 units of Curad Quick Strip Fabric Bandages because packaging may exhibit open seals that could compromise the sterility of the product.

    Product
    Deep-brand Select Arvi Net Wt. 12 oz. (340 g) KEEP FROZEN
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0901-2026·2025-12-17

    Quick Strip plastic bandages recalled over open seals affecting sterility

    Medline is recalling 4,381,400 Quick Strip Plastic Sterile Adhesive Bandages because packaging may exhibit open seals that could compromise the sterility of the product.

    Product
    Quick Strip Plastic Sterile Adhesive Bandages, 1" x 3", Medline Item Number NON25600QS
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·H-0281-2026·2025-12-17

    Quick Strip fabric bandages, 1 by 3 inch, recalled over open seals

    Medline is recalling 11,291,800 Quick Strip Fabric Sterile Adhesive Bandages, 1" x 3", because packaging may exhibit open seals that could compromise the sterility of the product.

    Product
    Deep-brand PREMIUM Select Garlic Cloves Net Wt. 12 oz. (340 g) KEEP FROZEN
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0903-2026·2025-12-17

    Quick Strip fabric bandages recalled over open seals affecting sterility

    Medline is recalling 6,989,900 Quick Strip Fabric Sterile Adhesive Bandages because packaging may exhibit open seals that could compromise the sterility of the product.

    Product
    Quick Strip Fabric Sterile Adhesive Bandages, 0.75" x 3", Medline Item Number NON25650QS
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2530-2025·2025-09-17

    ENT convenience packs recalled over open header bag seals compromising sterility

    Halyard ENT Packs, model JACK421-04, lot 1647218, are recalled because of the potential for open header bag seals, compromising sterility. 57 units are affected.

    Product
    Halyard, ENT PACK. Model Number: JACK421-04. Convenience kit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2511-2025·2025-09-10

    MediHoney surgical adhesive sheets recalled over sterile barrier packaging failures

    MediHoney HCS Surgical Adhesive Sheet dressings, catalog number 31738, lot 53824, are recalled after packaging failures were identified that could breach the sterile barrier. 4 units are affected.

    Product
    Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Surgical Adhesive Sheet Model/Catalog Number: 31738 Product Description: MEDIHONEY¿ HCS SURGICAL ADHESIVE SHEET DRESSINGS with LEPTOSPERMUM HONEY is a moist wound dressing made of Leptospermum Honey (+15) in combination with
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2506-2025·2025-09-10

    MediHoney paste tubes recalled over packaging failures breaching the sterile barrier

    MediHoney Paste tubes, catalog numbers 31515 and 31535, are recalled after packaging failures were identified that could lead to a breach in the sterile barrier. 141,620 units are affected.

    Product
    Brand Name: MediHoney ¿ Product Name: MediHoney ¿ Tube Model/Catalog Number: 31515 and 31535 Product Description: MediHoney¿ Paste with Active Leptospermum Honey is a moist dressing made of 100% Active Leptospermum medical grade Honey. The dressing helps maintain a moist envir
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2509-2025·2025-09-10

    MediHoney non-adhesive hydrogel dressings recalled over sterile barrier packaging failures

    MediHoney Non-Adhesive Hydrogel Sheet Dressings, catalog numbers 31620 and 31640, are recalled after packaging failures were identified that could breach the sterile barrier. 5,374 units are affected.

    Product
    Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Model/Catalog Number: 31620, 31640 Product Description: MEDIHONEY¿ Non-Adhesive Hydrogel Sheet Dressing with Leptospermum Honey is a moist wound dressing made of Leptospermum Honey (+15) in combination with a hydrogel ge
    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-2512-2025·2025-09-10

    CVS honey wound pads recalled over packaging failures breaching sterile barrier

    CVS Honey Pads, catalog numbers 9370613 and 937404, are recalled after packaging failures were identified that could lead to a breach in the sterile barrier. 111,492 units are affected.

    Product
    Brand Name: CVS Honey Pad Product Name: CVS Honey Pad Model/Catalog Number: 9370613, 937404 Product Description: Infused with natural medical-grade honey Manuka (Leptospermum) honey is a medical-grade honey that is harvested from bees in New Zealand. Researchers have found
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2520-2025·2025-09-10

    Surgical drape packs recalled because open seals may compromise sterility

    Orthopedic Pack model 88041-12 and Universal Pack model 77165-06 are recalled because the surgical drape packs may have open seals that could compromise sterility. 1,316 units are affected.

    Product
    Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC2424902B 09/05/2029
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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