The Recall Desk

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.

51–75 of 328

  • HighFDA (Devices)·Z-0899-2026·2025-12-17

    Medline Curad Quick Strip Bandages Recalled for Open Packaging Seals

    Medline is recalling Curad Quick Strip Fabric Bandages (18,000 units) due to open seals that may compromise sterility. Distribution affected: US, Guam, Canada, and United Arab Emirates.

    Product
    Curad Quick Strip Fabric Bandages Containing 30 Bandages of 3/4" x 3", Medline Item Number CUR1930P
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0898-2026·2025-12-17

    CURAD Germ-Shield Fabric Bandages recalled for potentially compromised sterility

    Medline is recalling CURAD Germ-Shield Touch-Free Fabric Bandages because packaging seals may be open, potentially compromising product sterility. Consumers should stop using affected units.

    Product
    CURAD Germ-Shield Touch-Free Fabric Bandages, Sterile, 0.75" x 3", 30/Box, Medline Item Number CUR1930F
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0904-2026·2025-12-17

    Medline Quick Strip Fabric Bandages recalled for potentially compromised sterility

    Medline is recalling all lots of Quick Strip Fabric Sterile Adhesive Bandages because open packaging seals may compromise product sterility. The recall affects 11,291,800 units.

    Product
    Quick Strip Fabric Sterile Adhesive Bandages, 1" x 3", Medline Item Number NON25660QS
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0482-2026·2025-11-19

    Olympus Electrosurgical Snare SD-400 Recalled for Sterility Compromise

    Olympus recalled 48,208 units of its Single-Use Electrosurgical Snare SD-400U-10 due to potential sterility compromise from small holes that may occur during packaging or transportation. Non-sterile instruments used in GI procedures could cause infection.

    Product
    Brand Name: Olympus Single Use Electrosurgical Snare SD-400 Product Name: Single Use Electrosurgical Snare Model/Catalog Number: SD-400U-10 Product Description: These instruments have been designed to be used with an Olympus endoscope for the removal and/or cauterization of di
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0483-2026·2025-11-19

    Olympus Electrosurgical Snares Recalled for Sterility Compromise

    Olympus Corporation recalls 18,174 electrosurgical snares due to sterility compromise from packaging defects. Small holes in device pouches may allow contamination of the surgical instruments.

    Product
    Brand Name: Olympus Single Use Single Use Electrosurgical Snare SD-400 Product Name: Single Use Single Use Electrosurgical Snare Model/Catalog Number: SD-U400U-15 Product Description: These instruments have been designed to be used with an Olympus endoscope for the removal and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0432-2026·2025-11-12

    Klassic BiPolar Head Hip Components Recalled for Potential Sterility Compromise

    Total Joint Orthopedics is recalling 103 Klassic BiPolar Head hip implant components distributed in five U.S. states due to potential packaging defects that could compromise device sterility and increase infection risk if implanted.

    Product
    Brand Name: Klassic BiPolar Head Model/Catalog Number: 3205.41.022 Klassic BiPolar Head, 41 mm OD, 22 mm Head; 3205.42.022 Klassic BiPolar Head, 42 mm OD, 22 mm Head; 3205.43.022 Klassic BiPolar Head, 43 mm OD, 22 mm Head; 3205.44.028 Klassic BiPolar Head, 44 mm OD, 28 mm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0326-2026·2025-11-05

    Alcon PRECISION1 Contact Lenses recalled due to weak seal defect

    Alcon is recalling PRECISION1 one-day contact lenses (Lot A8041128) because some units may have weak seals compromising sterility. The recall affects 82 units distributed across the US and Canada.

    Product
    Alcon PRECISION1 One-Day Contact Lenses, -2.25D.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0148-2026·2025-10-22

    BioPro Femoral Head recalled due to packaging sterility compromise risk

    BioPro, Inc. is recalling BioPro Femoral Head prosthetics due to a potential packaging defect that could compromise sterility. The defect may result in infection risk if the device is implanted.

    Product
    BioPro Femoral Head (Metal 22, 28, 32, 36, 40) cobalt chromium and ceramic heads Part ID/Description: 18593 HEAD FEMORAL 22MM -3 18594 HEAD FEMORAL 22MM +0 19003 HEAD FEMORAL 28MM-6 19004 HEAD FEMORAL 28MM-3 19005 HEAD FEMORAL 28MM+0 19006 HEAD FEMORAL 28MM+3 19007 HEAD
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0153-2026·2025-10-22

    BioPro Femoral Head Recall: Potential Sterile Packaging Compromise

    BioPro is recalling certain femoral head hip replacement components due to a potential packaging issue that could compromise sterility. The defect may result in loss of sterility, risking infection in implanted devices.

    Product
    BioPro Femoral Head Product ID/Description 14089 HEAD FEMORAL 28 SH LT 14090 HEAD FEMORAL 28 MD LT 14091 HEAD FEMORAL 28 LG LT 14094 HEAD FEMORAL 32 SH LT 14095 HEAD FEMORAL 32 MD LT 14096 HEAD FEMORAL 32 LG LT
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0134-2026·2025-10-22

    Cyclopen Microinterventional Cyclodialysis System Recalled for Compromised Sterile Packaging

    Iantrek Inc. is recalling 1,262 units of the Cyclopen Microinterventional Cyclodialysis System (Model CP-300) due to potential compromise of sterile packaging integrity. The devices were distributed nationwide.

    Product
    Cyclopen Microinterventional Cyclodialysis System. Model Number: CP-300. Product Description: The CycloPen Microinterventional Cyclodialysis device is a manual surgical instrument used for the ab-interno construction or modification of a cyclodialysis, followed by delivery of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0149-2026·2025-10-22

    BioPro Endo Head orthopedic implants recalled for sterile barrier packaging defect

    BioPro Endo Head orthopedic implants (147 units distributed to Texas and Michigan) are recalled due to a packaging defect that may compromise sterility, presenting a potential infection risk if implanted.

    Product
    BioPro Endo Head (Metal uni-polar, 38-55) Product Number/Description 10179 ENDO MD 38 10180 ENDO MD 41 10181 ENDO MD 43 10182 ENDO MD 45 10183 ENDO MD 47 10184 ENDO MD 49 10185 ENDO MD 51 10186 ENDO MD 53 10187 ENDO MD 55 10188 ENDO SH 38 10189 ENDO SH 41 10190 E
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0151-2026·2025-10-22

    BioPro Ceramic Femoral Head Implants Recalled for Potential Sterility Breach

    BioPro is recalling 147 ceramic femoral head implants due to a packaging defect that could compromise the sterile barrier. The defect poses a potential infection risk if the implanted device becomes contaminated.

    Product
    BioPro Femoral Head (Ceramic heads 28-30) Product ID/Description 19023 HEAD FEMORAL CERAMIC 28MM -3 19024 HEAD FEMORAL CERAMIC 28MM +0 19025 HEAD FEMORAL CERAMIC 32MM -3 19026 HEAD FEMORAL CERAMIC 32MM +0 19027 HEAD FEMORAL CERAMIC 32MM +3
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0025-2026·2025-10-08

    Laser Atherectomy Catheter Recall Due to Sterile Packaging Defects

    Northeast Scientific is recalling the NES Reprocessed Turbo Elite Laser Atherectomy Catheter due to potential breaches in sterile barrier packaging. The defect could compromise sterility assurance on 141 units distributed nationwide.

    Product
    NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-159. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cle
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2530-2025·2025-09-17

    ENT surgical kit recalled for potential sterility compromise

    AVID Medical is recalling Halyard ENT PACK convenience kits (Model JACK421-04) due to potential open header bag seals that could compromise product sterility. The recall affects 57 units distributed in Florida.

    Product
    Halyard, ENT PACK. Model Number: JACK421-04. Convenience kit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2520-2025·2025-09-10

    Surgical Drape Packs With Open Seals May Compromise Sterility

    O&M Halyard is recalling 1,316 surgical drape packs (Models 88041-12 and 77165-06) with open seals that may compromise product sterility. Products were distributed nationwide in Georgia, Alabama, Pennsylvania, and Mexico.

    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-2284-2025·2025-08-20

    Carefree Surgical Robotic Laparoscopy Kittner Gauze Recalled for Contamination

    Carefree Surgical Specialties is recalling Robotic/Laparoscopy Kittner Roll Gauze due to biological contamination that could compromise sterility and incorrect quantity in sterile packaging.

    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
  • HighFDA (Devices)·Z-2281-2025·2025-08-20

    Carefree Surgical Specialties surgical gauzes recalled due to sterility compromise

    Carefree Surgical Specialties recalls Robotic/Laparoscopy Kittner + Tail gauzes (Model 15508/25, Lot 1595) due to biological contamination that could compromise sterility and incorrect quantity 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-2283-2025·2025-08-20

    Carefree Kittner Rolls Surgical Gauze Recalled for Contamination and Incorrect Quantity

    Carefree Surgical Specialties is recalling Robotic/Laparoscopy Kittner Rolls Gauze due to biological contamination that could compromise sterility and incorrect quantities 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 (Drugs)·D-0586-2025·2025-08-20

    Intravenous Sodium Chloride Injection Recalled Due to Sterility and Leakage Risk

    B Braun Medical Inc. is recalling 23,100 containers of 0.9% Sodium Chloride Injection nationwide due to lack of sterility assurance and potential fluid leakage at weld sites. The intravenous medication may become contaminated.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2282-2025·2025-08-20

    Carefree Robotic/Laparoscopy Kittner Rolls Gauze recalled for contamination and incorrect quantity

    Carefree Surgical Specialties is recalling Robotic/Laparoscopy Kittner Rolls Gauze (Lot 1645) due to biological foreign matter contamination and incorrect quantity in sterile packaging, affecting 500 units distributed nationwide.

    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-2105-2025·2025-07-16

    Transseptal Sheath Kit sterile barrier integrity issue with infection risk

    Boston Scientific is recalling VersaCross Transseptal Sheath Kits due to potential holes in the sterile barrier pouch that could compromise device sterility and lead to infection or sepsis.

    Product
    VersaCross Transseptal Sheath Kit (VXS) Product Description/IDs VXS0201 VXS 63CM/45DEG/D0 SHEATH VXS2112 VERSACROSS SHEATH (63CM 45DEG D0)-J Used for the percutaneous introduction of various types of cardiovascular catheters and guidewires to all heart chambers, includ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2108-2025·2025-07-16

    Alcon Constellation Vitrectomy Procedure Pak Recalled for Potential Manufacturing Defect

    Alcon Laboratories is recalling specific lots of Constellation Vision System Vitrectomy Procedure Paks due to potential manufacturing damage to the lidding that could compromise sterility.

    Product
    Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Vitrectomy Procedure Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Surgical procedure pack to interface with Alcon Constella
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2110-2025·2025-07-16

    Alcon Custom Pak Surgical Packs Recalled for Potential Sterility Compromise

    Alcon Custom Pak sterile surgical procedure packs are being recalled because some units may have damage to the packaging's lid area, which could compromise sterility. No illnesses have been reported.

    Product
    Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intende
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2109-2025·2025-07-16

    Alcon Constellation Vision System Procedure Packs Recalled for Sterility Risk

    Alcon Laboratories is recalling certain Constellation Vision System Combined Procedure Paks (89,495 units) due to potential damage to the lidding that may compromise sterility. Affected products were distributed worldwide.

    Product
    Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Combined Procedure Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Surgical procedure pack to interface with Alcon Constellati
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0491-2025·2025-07-02

    Sodium Chloride Injection recalled for packaging sterility defects

    B Braun Medical is recalling 187,656 containers of 0.9% Sodium Chloride Injection USP due to pinholes in packaging that compromise sterility assurance in this intravenous product.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide