The Recall Desk

Hazard

Sterility Assurance recalls

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

What the numbers show

Total
663
Critical
0
Severe
261
Most recent
2026-08-26

Of the 663 sterility assurance recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 261 (39%) 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 assurance 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.

201–225 of 663

  • HighFDA (Drugs)·D-0079-2026·2025-10-15

    Proline injection recalled across all lots for lack of sterility assurance

    GenoGenix is recalling Proline for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.

    Product
    Proline for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0073-2026·2025-10-15

    EDTA for injection recalled across all lots over sterility assurance

    GenoGenix is recalling EDTA for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.

    Product
    EDTA for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0084-2026·2025-10-15

    Zinc chloride injection recalled across all lots for lack of sterility

    GenoGenix is recalling Zinc Chloride for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.

    Product
    Zinc Chloride for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0080-2026·2025-10-15

    Buffered reconstitution solution recalled across all lots over sterility assurance

    GenoGenix is recalling pH Buffered Reconstitution Solution for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.

    Product
    pH Buffered Reconstitution Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Medical Health Institute (MHI), 10mL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0072-2026·2025-10-15

    CoQ10 for injection recalled across all lots over sterility assurance

    GenoGenix is recalling CoQ10 for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.

    Product
    CoQ10 for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0041-2026·2025-10-15

    Preserved ascorbic acid injection recalled across all lots over sterility assurance

    GenoGenix is recalling preserved Ascorbic Acid (Vitamin C) for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.

    Product
    Ascorbic Acid (Vitamin C) for Injection, Preserved, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0003-2026·2025-10-15

    Bevacizumab intravitreal syringes recalled for lack of sterility assurance

    RC Outsourcing is recalling 2,669 prefilled Bevacizumab 1.75 mg/0.07 mL intravitreal syringes for lack of assurance of sterility.

    Product
    Bevacizumab 1.75 mg/0.07 mL - 0.25 mL syringe, Intravitreal, 0.07 mL Total Volume, Rx Only, Hospital/Office Use Only, Refrigerate, RC Outsourcing LLC, Lowellville, OH 44436.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0053-2026·2025-10-15

    Preserved glutathione injection recalled across all lots for sterility assurance

    GenoGenix is recalling Glutathione Preserved for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.

    Product
    Glutathione Preserved for Injection, all strengths and presentations, GenoGenix LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0038-2026·2025-10-15

    Alpha lipoic acid injection recalled across all lots over sterility assurance

    GenoGenix is recalling Alpha Lipoic Acid for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.

    Product
    Alpha Lipoic Acid for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0047-2026·2025-10-15

    B-Complex injection recalled across all lots over lack of sterility assurance

    GenoGenix is recalling B-Complex for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.

    Product
    B-Complex for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. B-Complex with B12 also labeled as manufactured for Synergy Wellness.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0044-2026·2025-10-15

    Dexpanthenol B5 injection recalled across all lots over sterility assurance

    GenoGenix is recalling B5 Dexpanthenol for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.

    Product
    B5 Dexpanthenol for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0093-2026·2025-10-15

    Retatrutide injection recalled from one lot for lack of sterility assurance

    GenoGenix is recalling Retatrutide for Injection, 60mg/10mL vial, from a single lot for lack of assurance of sterility.

    Product
    Retatrutide for Injection, 60mg / 10mL vial, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0075-2026·2025-10-15

    Elite Stack reconstitution solution recalled across all lots over sterility assurance

    GenoGenix is recalling Elite Stack Reconstitution Solution for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.

    Product
    Elite Stack Reconstitution Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Extension Health and Medical Health Institute (MHI).
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0024-2026·2025-10-08

    Reprocessed 1.7mm laser atherectomy catheters recalled over sterile barrier breaches

    Northeast Scientific is recalling 616 reprocessed 1.7mm RX Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.

    Product
    NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-156. 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-0025-2026·2025-10-08

    Reprocessed 2.0mm laser atherectomy catheters recalled for sterile packaging breaches

    Northeast Scientific is recalling 141 reprocessed 2.0mm RX Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.

    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-0022-2026·2025-10-08

    Reprocessed 0.9mm rapid exchange atherectomy catheters recalled for sterile barrier breaches

    Northeast Scientific is recalling 795 reprocessed 0.9mm RX Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.

    Product
    NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter. Model/Catalog Number: R-410-154. 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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0021-2026·2025-10-08

    Reprocessed 2.0mm over the wire atherectomy catheters recalled for packaging breaches

    Northeast Scientific is recalling 199 reprocessed 2.0mm OTW Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.

    Product
    NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-006. 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 cl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0676-2025·2025-10-08

    Glaucoma eye drops recalled over sterility assurance and bottle sealing concerns

    Apotex is recalling 151,034 bottles of Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution because atypical weight loss from improper bottle sealing raises sterility concerns.

    Product
    BRIMONIDINE TARTRATE/TIMOLOL MALEATE OPHTHALMIC SOLUTION — BRIMONIDINE TARTRATE/TIMOLOL MALEATE OPHTHALMIC SOLUTION (BRIMONIDINE TARTRATE AND TIMOLOL MALEATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0018-2026·2025-10-08

    Reprocessed 0.9mm over the wire atherectomy catheters recalled for packaging breaches

    Northeast Scientific is recalling 561 reprocessed 0.9mm OTW Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.

    Product
    NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-410-152. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0023-2026·2025-10-08

    Reprocessed 1.4mm rapid exchange atherectomy catheters recalled for packaging breaches

    Northeast Scientific is recalling 1,019 reprocessed 1.4mm RX Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.

    Product
    NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-159. 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-0019-2026·2025-10-08

    Reprocessed 1.4mm over the wire atherectomy catheters recalled for sterility breaches

    Northeast Scientific is recalling 173 reprocessed 1.4mm OTW Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.

    Product
    NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-151. 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 no
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0020-2026·2025-10-08

    Reprocessed 1.7mm over the wire atherectomy catheters recalled for sterility breaches

    Northeast Scientific is recalling 165 reprocessed 1.7mm OTW Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.

    Product
    NES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-152. 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 cl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0653-2025·2025-09-24

    Sodium chloride irrigation bags recalled over port misalignment allowing fluid leakage

    B. Braun 0.9% Sodium Chloride Irrigation USP, 3000 mL bags, is recalled for lack of assurance of sterility because port misalignment may allow fluid leakage. 16,228 bags are affected.

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