The Recall Desk

Hazard

Infection Risk recalls

3,438 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
3,438
Critical
25
Severe
993
Most recent
2026-10-14

Of the 3,438 infection risk recalls we have scored against our rubric, 25 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 993 (29%) 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 infection risk 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 3438

  • HighFDA (Drugs)·D-0120-2026·2025-11-05

    Compounded tirzepatide vials recalled for lack of sterility assurance

    ProRx is recalling 2,761 vials of Tirzepatide Injection 27 mg/3 mL from one lot for lack of assurance of sterility.

    Product
    Tirzepatide Injection, 27 mg/3 mL (9 mg/mL), 3mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-209-03
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-0114-2026·2025-11-05

    Compounded semaglutide vials recalled for lack of sterility assurance

    ProRx is recalling 2,809 vials of Semaglutide Injection 12.5 mg/5 mL from one lot for lack of assurance of sterility.

    Product
    Semaglutide Injection, 12.5/5mL (2.5 mg/mL), 5mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-09
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Devices)·Z-0304-2026·2025-11-05

    Vitrectomy probe accessories recalled over incomplete seals in sterile pouches

    Alcon Research is recalling 577 accessory devices for Unity and Constellation surgical consoles because of incomplete seals in the pouch that provides the sterile barrier.

    Product
    Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000250 UNITY 27+DS HYPERVIT 30K VIT PROBE 8065753168 UNITY 25+ 7.5K ANTERIOR VIT…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0097-2026·2025-10-29

    Opdualag injection vials recalled from one lot over sterility assurance

    Bristol-Myers Squibb is recalling 12,778 vials of Opdualag (nivolumab and relatlimab-rmbw) injection from one lot for lack of assurance of sterility.

    Product
    OPDUALAG — OPDUALAG (NIVOLUMAB AND RELATLIMAB-RMBW)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0035-2026·2025-10-29

    Alcohol prep pads recalled from one lot as a subpotent drug

    Medline is recalling 222,800 alcohol prep pads from one lot because the product is subpotent.

    Product
    Medline, Alcohol Prep Pads (2-Ply Pad, 70% Isopropyl Alcohol), 100 eaches per box, 10 boxes per case (1,000 eaches per case), Single Use Only, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL, 60093 USA, NDC 55329-811-30.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0153-2026·2025-10-22

    Femoral head implants recalled over packaging that may compromise sterile barrier

    BioPro is recalling 147 femoral head implants over a potential packaging issue that could compromise the sterile barrier and present a risk of infection if implanted.

    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
    2 states
  • HighFDA (Devices)·Z-0149-2026·2025-10-22

    Uni-polar endo heads recalled over packaging that may compromise sterility

    BioPro is recalling 147 metal uni-polar Endo Heads over a potential packaging issue that could compromise the sterile barrier and risk infection 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…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0150-2026·2025-10-22

    Bipolar femoral heads recalled over packaging that may compromise sterility

    BioPro is recalling 147 bipolar heads over a potential packaging issue that could compromise the sterile barrier and risk infection if implanted.

    Product
    BioPro Bipolar Head Product ID/Description 18130 BIPOLAR HEAD 38MM 18131 BIPOLAR HEAD 39MM 18132 BIPOLAR HEAD 40MM 18133 BIPOLAR HEAD 41MM 18134 BIPOLAR HEAD 42MM 18135 BIPOLAR HEAD 43MM 18136 BIPOLAR HEAD 44MM 18137 BIPOLAR HEAD 45MM 18138 BIPOLAR HEAD 46MM 18139…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0151-2026·2025-10-22

    Ceramic femoral heads recalled over packaging that may compromise sterile barrier

    BioPro is recalling 147 ceramic femoral heads over a potential packaging issue that could compromise the sterile barrier and present a risk of infection if implanted.

    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
    2 states
  • HighFDA (Devices)·Z-0152-2026·2025-10-22

    Ceramic endo modular heads recalled over sterile barrier packaging defect

    BioPro is recalling 147 ceramic Endo Modular Heads over a potential packaging issue that could compromise the sterile barrier and risk infection if implanted.

    Product
    BioPro Endo Head (Ceramic) Product ID/Description 13006 ENDO MODULAR CERAMIC SH 38 13012 ENDO MODULAR CERAMIC SH 51 13013 ENDO MODULAR CERAMIC MD 38 13019 ENDO MODULAR CERAMIC MD 51 13007 ENDO MODULAR CERAMIC SH 41 13008 ENDO MODULAR CERAMIC SH 43 13009 ENDO MODULAR…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0147-2026·2025-10-22

    Linear cutter reloads recalled after devices were shipped unsterilized

    Ethicon Endo-Surgery is recalling three ECHELON LINEAR Cutter Reload 80 mm Blue units because the devices were shipped unsterilized.

    Product
    ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product Number GLC80
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0135-2026·2025-10-22

    Goniotomy instruments recalled over compromised sterile packaging integrity

    Iantrek is recalling 198 C-Rex UNO Microinterventional Goniotomy Instruments over the potential for compromised integrity of the sterile packaging.

    Product
    C-Rex UNO Microinterventional Goniotomy Instrument. Model Number: CRX-120. Product Description: The C-Rex UNO Microinterventional Goniotomy Instrument is a sterile single use disposable manual surgical instrument used in ophthalmic procedures for ab interno goniotomy and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0148-2026·2025-10-22

    Metal and ceramic femoral heads recalled over sterile barrier packaging defect

    BioPro is recalling 147 cobalt chromium and ceramic femoral heads over a potential packaging issue that could compromise the sterile barrier and risk infection if 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…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0134-2026·2025-10-22

    Cyclodialysis surgical instruments recalled over compromised sterile packaging integrity

    Iantrek is recalling 1,262 CycloPen Microinterventional Cyclodialysis Systems over the potential for compromised integrity of the sterile packaging.

    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 (Drugs)·D-0088-2026·2025-10-15

    Tesamorelin injection recalled from one lot for lack of sterility assurance

    GenoGenix is recalling Tesamorelin for Injection, 15mg in a 10 mL multi-dose vial, from a single lot for lack of assurance of sterility.

    Product
    Tesamorelin for Injection, 15mg, 10 mL Multi-Dose Vial, 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-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-0040-2026·2025-10-15

    Ascorbic acid injection recalled across all lots for sterility assurance concerns

    GenoGenix is recalling preservative-free 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, Preservative Free, 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-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-0057-2026·2025-10-15

    L-Carnitine for injection recalled across all lots over sterility assurance

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

    Product
    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-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-0083-2026·2025-10-15

    Semaglutide with B12 injection recalled across all lots over sterility

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

    Product
    Semaglutide with B12 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-0071-2026·2025-10-15

    Cerebrolysin injection recalled across all lots for lack of sterility assurance

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

    Product
    Cerebrolysin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
    Category
    Drug
    Distribution
    Distributed nationwide