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.

3101–3125 of 3438

  • ModerateFDA (Devices)·Z-1034-2014·2014-02-26

    Zimmer Recalls 6 Degree COCR Femoral Heads Due to Packaging Validation Issues

    Zimmer is recalling 6 Degree COCR Femoral Heads because packaging operations at its Puerto Rico facility were not properly validated, despite passing seal integrity tests.

    Product
    6 DEGREE COCR FEM HEAD 36
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1011-2014·2014-02-26

    Zimmer Recalls Humeral Intramedullary Nails Due to Packaging Validation Issues

    Zimmer is recalling 7,044,680 humeral intramedullary nails because packaging operations at its Puerto Rico facility were not properly validated, despite passing seal integrity tests.

    Product
    M/DN HUMERAL I/M NAIL. Sizes from 6 MM to 13 MM. Codes starting with 0022541, 002542 and 0022543.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0947-2014·2014-02-19

    Ecolab Recalls Microtek Medical Bur Hole Latex Probe Covers

    Ecolab Inc is recalling specific lots of Microtek Medical Bur Hole Latex Probe Covers because they did not undergo proper endotoxin testing.

    Product
    MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER WITH GEL, featuring IsoSilk(R), 13cm x 249 cm, REF 3688UK, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0948-2014·2014-02-19

    Ecolab Recalls Vital Care Ultrasound Probe Covers Due to Testing Deficiencies

    Ecolab Inc is recalling specific lots of Vital Care ultrasound probe covers because they did not undergo endotoxin testing to the proper levels.

    Product
    Vital CARE(TM) REPS INC. ULTRASOUND PROBE COVER, BUR HOLE COVER, 5 x 96, REF VPC0699, STERILE EO, QTY 20, Manufactured for Vital Care Reps, Inc., Tinley Park, Illinois
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1039-2014·2014-02-05

    Mentholatum Recalls Rohto Eye Drops Due to Sterility Concerns

    The Mentholatum Company is recalling several Rohto eye drop products due to concerns about the quality assurance of sterility controls.

    Product
    ROHTO Dry Eye, hydra, Lubricant Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL). UPC 3 10742 01096 1, Manufactured by Rohto-Mentholatum (Vietnam) Co., Ltd. for The Mentholatum Company, Orchard Park, NY 14127. Made in Vietnam.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1038-2014·2014-02-05

    Mentholatum Recalls Rohto Eye Drops Due to Sterility Concerns

    The Mentholatum Company is recalling Rohto eye drops because of concerns about the quality assurance of sterility controls.

    Product
    ROHTO Redness Relief, ice, Redness Reliever, Lubricant, Astringent Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL). UPC 3 10742 01086 2, Manufactured by Rohto-Mentholatum (Vietnam) Co., Ltd. for The Mentholatum Company, Orchard Park, NY 14127. Made in Vietnam.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0826-2014·2014-02-05

    Navilyst Medical Recalls Port Kits Due to Sterilization Barrier Breach

    Navilyst Medical is recalling 920 Port Kits with Access Infusion Sets due to a possible breach of the sterilization barrier. The devices were distributed nationwide.

    Product
    Port Kit with Access Infusion Set under the following labels: 1) 8F/SL/Plastic Port/F, Product Number H965450140, Catalog Number 45-014; 2) 8F/SL/Titanium Ports/NF, Product Number H965450170, Catalog Number 45-017; 3) 6F/SL/Plastic Port/F, Product Number H965450200, Catalog…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0809-2014·2014-01-29

    CryoLife Pulmonary Hemi-Artery SG Recalled Due to Donor Testing Concerns

    CryoLife, Inc. is recalling one Pulmonary Hemi-Artery SG device used in heart surgery because donor serological testing may have been compromised by hemodilution.

    Product
    Pulmonary Hemi-Artery SG Used in heart surgery
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Drugs)·D-458-2014·2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls 0.9% Sodium Chloride Due to Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling 0.9% Sodium Chloride injectable and topical products because sterility cannot be assured after a related product was found non-sterile.

    Product
    0.9% Sodium chloride a) DT-0.9% Sodium chloride* 100 mL Drug Study - IV 100 mL Injectable, b) DT-0.9% Sodium Chloride* 100 mL Drug Study - Topical, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-438-2014·2014-01-22

    Phenol Injectable Recalled Due to Lack of Sterility Assurance

    Specialty Medicine Compounding Pharmacy is recalling Phenol, 6%, Injectable, because sterility cannot be assured after a related product was found non-sterile.

    Product
    Phenol, 6%, Injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-414-2014·2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls Combo Eye Gel Due to Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling Combo Eye Gel because sterility cannot be assured after another product was found non-sterile in the same environment.

    Product
    Combo Eye Gel, HF COMBO EYE GEL* (cyclopentolate 2%, tropicamide 1%, diclofenac sodium 0.1%, ciprofloxacin 0.3%, phenylephrine 10%, lidocaine jelly 2%), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0723-2014·2014-01-22

    Boston Scientific Recalls TWISTER PLUS Retrieval Devices Due to Seal Issues

    Boston Scientific is recalling TWISTER PLUS 26mm Rotatable Retrieval Devices because the pouch seal integrity may be compromised, potentially affecting sterility.

    Product
    TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 5 configuration) Universal Product Number (UPN):M00561421. Distributed by: Boston Scientific, Natick, MA. Manufactured by: Horizons International Corp., Costa Rica. Intended to be used in flexible endoscopes as a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-459-2014·2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls Sterile Compounded Products Due to Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling unexpired sterile compounded human and veterinary products because sterility cannot be assured after a related product was found non-sterile.

    Product
    DT- Tranexamic Acid* 2 gm/100 mL Drug Study -IV 100 mL injectable, DT-, DT-Tranexamic Acid* 2 gm/100 mL-Drug Study-Topical 100 mL Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-429-2014·2014-01-22

    Magnesium Sulfate Injection Recalled Due to Sterility Assurance Concerns

    Specialty Medicine Compounding Pharmacy is recalling Magnesium Sulfate injections because sterility cannot be assured after a related product was found non-sterile.

    Product
    Magnesium Sulfate, 1 gm/50 mL; 2 gm/50 mL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-451-2014·2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls Sterile Compounded Products for Sterility Assurance

    Specialty Medicine Compounding Pharmacy is recalling all unexpired sterile compounded human and veterinary products because sterility cannot be assured due to shared compounding practices with a non-sterile product.

    Product
    TRANEXAMIC ACID* 2 g/75 mL SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-449-2014·2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls Testos Cypionate Injectable Due to Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling Testos Cypionate injectable products because sterility cannot be assured after a related product was found non-sterile.

    Product
    TESTOS CYPIONATE* IN OIL 100 mg/mL INJECTABLE, TESTOS CYPIONATE* IN OIL 200 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-434-2014·2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls Naltrexone MDV Injectable

    Specialty Medicine Compounding Pharmacy is recalling Naltrexone MDV 1mg/mL injectable because sterility cannot be assured due to shared compounding practices with a non-sterile product.

    Product
    NALTREXONE* MDV 1MG/ML INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-453-2014·2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls Triple Mix Injectable Due to Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling Triple Mix injectable products because sterility cannot be assured after a related product was found non-sterile.

    Product
    TRIPLE MIX* 15 mg/1 mg/20 mcg/mL INJECTABLE, TRIPLE MIX* 30 mg/1 mg/20 mcg/mL INJECTABLE (papaverine hydrochloride, phentolamine, prostaglandin), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-455-2014·2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls VIGAMOX Syringes Due to Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling 204 doses of VIGAMOX (moxifloxacin) syringes because sterility cannot be assured after another product was found non-sterile.

    Product
    VIGAMOX (moxifloxacin)* IN BSS (0.15 %) 0.75 mg/0.5 mL PREF SYRINGE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-423-2014·2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls Glutathione PF Inhalation Solution

    Specialty Medicine Compounding Pharmacy is recalling Glutathione PF inhalation solution because sterility cannot be assured due to shared compounding practices with a non-sterile product.

    Product
    Glutathione PF, 60 mg/mL inhalation, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-457-2014·2014-01-22

    Calcium Chloride Injection Recalled Due to Sterility Assurance Concerns

    Specialty Medicine Compounding Pharmacy is recalling Calcium Chloride PF 500 mg/mL prefilled syringes because sterility cannot be assured after a related product was found non-sterile.

    Product
    Calcium Chloride* PF 500 mg/mL pref syringe, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-456-2014·2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls WB-Tranexamic Acid Due to Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling WB-Tranexamic acid products because sterility cannot be assured after a related product was found to be non-sterile.

    Product
    WB-Tranexamic acid, 2 g/Placebo 100 mL, DRUG STUDY, packaged as a) 100 mL INJECTABLE, b) TOPICAL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-460-2014·2014-01-22

    Sodium Hydroxide Solution Recalled Due to Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling Sodium Hydroxide 10% Solution because sterility cannot be assured after a related product was found non-sterile.

    Product
    SODIUM HYDROXIDE (BAC.STATIC) 10% SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-0720-2014·2014-01-22

    Boston Scientific Recalls TWISTER PLUS Retrieval Devices Due to Seal Integrity Issues

    Boston Scientific is recalling 425 TWISTER PLUS 22mm Rotatable Retrieval Devices because the pouch seal integrity may be compromised, potentially affecting sterility.

    Product
    TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 5 configuration) Universal Product Number (UPN): M00561411. Distributed by: Boston Scientific. Manufactured by: Horizons International Corp. Intended to be used in flexible endoscopes as a retrieval device for foreign…
    Category
    Medical Device
    Distribution
    Distributed nationwide