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.

151–175 of 663

  • HighFDA (Devices)·Z-0173-2026·2025-10-22

    Labor and delivery packs recalled after being sterilized more than once

    American Contract Systems is recalling labor, delivery and birthing room convenience kits that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.

    Product
    Medical convenience kits Item number/ Product description AHLD15X LABOR DELIVERY PACK - 213387 AKDV96B VAGINAL DELIVERY AKDV96B VAGINAL DELIVERY EVBH28D BIRTHING ROOM PACK UPVD01K VAGINAL DELIVERY PACK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0186-2026·2025-10-22

    PICC and gastrostomy tube packs recalled after being sterilized more than once

    American Contract Systems is recalling PICC G-Tube convenience packs that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.

    Product
    Medical convenience kits UDPG88W PICC G-TUBE PACK-230209
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0177-2026·2025-10-22

    Central line insertion kits recalled after being sterilized more than once

    American Contract Systems is recalling 32,433 adult central line insertion supply kits that were re-gassed after a nonconformance, without validation for multiple sterilization cycles.

    Product
    Medical convenience kits Item Number/Description UICL44P ADULT CENTRAL LINE INSERTION SUPPLY KIT UICL44R ADULT CENTRAL LINE INSERTION SUPPLY KIT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0182-2026·2025-10-22

    Radiology procedure packs recalled after being sterilized more than once

    American Contract Systems is recalling radiology convenience packs that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.

    Product
    Medical convenience kits Item Number/Description LKRA40G RADIOLOGY PACK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0187-2026·2025-10-22

    Dilation and curettage packs recalled after being sterilized more than once

    American Contract Systems is recalling D and C convenience packs that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.

    Product
    Medical convenience kits IHDC30R D AND C PACK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0185-2026·2025-10-22

    Eye and cataract packs recalled after being sterilized more than once

    American Contract Systems is recalling cataract, eye, retinal and vitrectomy convenience packs that were re-gassed after a sterilization nonconformance.

    Product
    Medical convenience kits Item Number/Description BFCT04X CATARACT PACK - 205986 CMEY17AI EYE PACK - 213187 CMEY17AI EYE PACK - 213187 CMEY17AI EYE PACK - 213187 PERP25AQ PEI RETINAL PACK-206025 RFEY50AC EYE PACK-206026 UIVT47AS VITRECTOMY SUPPLY
    Category
    Medical Device
    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-0092-2026·2025-10-15

    Tirzepatide injection recalled from two lots over lack of sterility assurance

    GenoGenix is recalling Tirzepatide 60mg/10 mL for Injection from two lots for lack of assurance of sterility.

    Product
    Tirzepatide, 60mg/10 mL for Injection, 10mL vial lyophilized, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Extension Health and Synergy Wellness 60mg, 10mL vial lyophilized.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0070-2026·2025-10-15

    Zinc sulfate injection recalled across all lots for sterility assurance concerns

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

    Product
    Zinc Sulfate 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-0059-2026·2025-10-15

    Lipo MIC with L-Carnitine injection recalled over lack of sterility assurance

    GenoGenix is recalling Lipo MIC + L-Carnitine for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.

    Product
    Lipo MIC + L-Carnitine 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-0039-2026·2025-10-15

    Amino blend for injection recalled across all lots over sterility assurance

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

    Product
    Amino Blend 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-0081-2026·2025-10-15

    Reconstitution XO solution recalled across all lots over sterility assurance

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

    Product
    Reconstitution XO 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 CELIA Health a) 5% Exosomes, 10 mL vial and b) 10% Exosomes, 5 mL vial, Extension Health a) 20% Exosomes,
    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-0042-2026·2025-10-15

    Hydroxocobalamin B12 injection recalled across all lots for sterility assurance

    GenoGenix is recalling B12 Hydroxocobalamin for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.

    Product
    B12 Hydroxocobalamin 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-0054-2026·2025-10-15

    Glycine for injection recalled across all lots over sterility assurance

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

    Product
    Glycine 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-0046-2026·2025-10-15

    Bacteriostatic water for injection recalled over lack of sterility assurance

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

    Product
    Bacteriostatic Water for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for CELIA Health, Extension Health and Medical Health Institute
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0048-2026·2025-10-15

    Biotin for injection recalled across all lots over sterility assurance

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

    Product
    Biotin 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-0052-2026·2025-10-15

    Glutathione magnesium injection recalled across all lots over sterility assurance

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

    Product
    Glutathione Magnesium for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for CELIA Health.
    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-0069-2026·2025-10-15

    Vitamin D3 for injection recalled across all lots over sterility assurance

    GenoGenix is recalling Vitamin D3 for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.

    Product
    Vitamin D3 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-0060-2026·2025-10-15

    Lipo MIC with B12 injection recalled across all lots over sterility

    GenoGenix is recalling Lipo MIC + B12 Methylcobalamin for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.

    Product
    Lipo MIC +B12 Methylcobalamin 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-0066-2026·2025-10-15

    Taurine for injection recalled across all lots over sterility assurance

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

    Product
    Taurine 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-0061-2026·2025-10-15

    Lysine for injection recalled across all lots over sterility assurance

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

    Product
    Lysine 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-0062-2026·2025-10-15

    Magnesium chloride injection recalled across all lots over sterility assurance

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

    Product
    Magnesium 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-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