The Recall Desk

Hazard

Non Sterile recalls

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

What the numbers show

Total
137
Critical
3
Severe
21
Most recent
2026-06-17

Of the 137 non sterile recalls we have scored against our rubric, 3 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 21 (15%) 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 non sterile 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.

126–137 of 137

  • ModerateFDA (Devices)·Z-1907-2017·2017-05-10

    Breg Inc Recalls Dressing Back P/N 09810 Due to Unsealed Pouches

    Breg Inc is recalling 2,609 units of Dressing Back P/N 09810 because approximately 0.22% may have unsealed pouches, rendering them non-sterile.

    Product
    Dressing Back, P/N 09810 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2830-2016·2016-09-21

    C.R. Bard Recalls Option-vf Urinary Catheters Due to Sterility Concerns

    C.R. Bard is recalling 274 units of Option-vf Urinary Catheters because an FDA inspection found them to be potentially nonsterile.

    Product
    Option-vf Urinary Catheter. Female use only. Latex Free. Sterile, Rx only.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-2831-2016·2016-09-21

    C.R. Bard Recalls Option-vm Urinary Catheters Due to Sterility Concerns

    C.R. Bard is recalling 274 units of Option-vm Urinary Catheters because an FDA inspection found them potentially nonsterile. The devices were distributed to 15 states.

    Product
    Option-vm Urinary Catheter. Male use only. Latex Free. Sterile, Rx only.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1360-2016·2016-04-20

    Arthrex Deltoid Ligament Implant Recalled for Potential Sterility Issue

    Arthrex is recalling 117 Deltoid Ligament Reconstruction Implant Systems because a component may not be sterile.

    Product
    Arthrex Deltoid Ligament Reconstruction Implant System. Intended as a fixation post, a distribution bridge or for distributing suture tension over areas of ligament or tendon repair utilizing titanium buttons.
    Category
    Medical Device
    Distribution
    22 states
  • HighFDA (Devices)·Z-0493-2015·2014-12-10

    Bard Access Systems Recalls Non-Sterile GuardIVa Antimicrobial Hemostatic IV Dressing

    Bard Access Systems is recalling non-sterile GuardIVa Antimicrobial Hemostatic IV Dressing units that could potentially be used clinically.

    Product
    GuardIVa Antimicrobial Hemostatic IV Dressing, REF FP-23-AD008, Manufacturer: Bard Access Systems, Inc. USA. Product Code FP23AD006.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1649-2014·2014-05-28

    Medline Esmark Elastic Bandages Recalled for Sterilization Failure

    Medline Industries is recalling 2,860 Esmark Elastic Bandages because they may not have been properly sterilized.

    Product
    Esmark Elastic Bandage (Sterile), 4" x 9'. Item DYNJ05116A, Individually wrapped, 20 bandages per case. Packaged by Medline Industries Inc. This product is used as an elastic bandage to support and compress a part of a patient's body. It is also used as a tourniquet to restrict b
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1526-2013·2013-06-19

    Bard UltraClip Breast Tissue Markers Recalled for Lack of Sterilization

    Bard Peripheral Vascular is recalling 815 UltraClip breast tissue markers because they were distributed without completing the sterilization process.

    Product
    BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), UltraClip¿ Dual Trigger Breast Tissue Marker 17g X 10cm needle, Ultrasound Enhanced Coil Marker 5 Pack; Sterilize, Non-pyrogenic, Rx only, Single Use; Bard Peripheral Vascular, Inc., 1625 West 3rd Street, Te
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1529-2013·2013-06-19

    Bard Usher Support Catheters Recalled for Incomplete Sterilization

    Bard Peripheral Vascular is recalling 223 Usher Support Catheters that were distributed without completing the sterilization process.

    Product
    USHER¿ Support Catheter- Angled Tip WL130cm, RI 7F; REF USH07AT; PK1022-01A; Rx only, Non-Pyrogenic, Sterile; Bard Peripheral Vascular; Manuf: FlowCardia, Inc., a Subsidiary of C. R. Bard, Inc., 745 North Pastoria Ave, Sunnyvale CA 95085. The Usher¿ Peripheral is a single lu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1527-2013·2013-06-19

    Bard UltraClip Breast Tissue Markers Recalled for Lack of Sterilization

    Bard Peripheral Vascular is recalling 315 UltraClip breast tissue markers that were distributed without completing the sterilization process.

    Product
    BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), UltraClip¿ Dual Trigger Breast Tissue Marker 17g X 10cm needle, Ultrasound Enhanced Ribbon Marker 5 Pack, Sterile, Single Use, Non-pyrogenic, Rx only; Bard Peripheral Vascular, Inc., 1625 West 3rd Street, Te
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1528-2013·2013-06-19

    Bard MicroSheath and Usher Catheters Recalled for Lack of Sterilization

    Bard Peripheral Vascular is recalling 17 MicroSheath and Usher support catheters because they were distributed without completing the sterilization process.

    Product
    MICROSHEATH¿ - 0.066 (1.7mm) proximal, 0.064 (1.6mm); WL 123cm, RGC 8F Guide; minimum ID: 0.086"/ (2.2mm);distal, straight non-tapered tip; PK1018-03A; Bard Peripheral Vascular; Manuf: Flow Cardia, Inc., a Subsidiary of C.R. Bard, Inc. 745 North Pastoria Ave., Sunnyvale, CA 94085
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2362-2012·2012-09-19

    Exactech Recalls Novation Modular Drill Bits for Non-Sterile Condition

    Exactech is recalling two Novation Modular Drill Bits after they were reported to have been used in a non-sterile condition.

    Product
    REF 101-05-30***NOVATION MODULAR DRILL BIT LENGTH: 30mm, DIAMETER 3.2mm***Use with 30mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantation of Novation Hip system components in according to a conventional technique
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1897-2012·2012-07-04

    Ethicon Surgiflo Hemostatic Matrix Kit Recalled for Potential Non-Sterility

    Ethicon is recalling Surgiflo Hemostatic Matrix Kits with Thrombin because an undetected air leak during manufacturing may have compromised the sterility of the thrombin component.

    Product
    Ethicon Surgiflo Hemostatic Matrix Kit with Thrombin Plus Flex Tip Distributed by Ethicon Ethicon Inc., Somerville, NJ 08876 USA Manufactured by Ferrosan Medical Devices Ferrosan Medical Devices A/S Sydmarken 5, DK-2860 Soeberg, Denmark Mixed with sterile saline or thromb
    Category
    Medical Device
    Distribution
    Distributed nationwide