The Recall Desk

Hazard

Infection recalls

2,547 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
2,547
Critical
31
Severe
1,678
Most recent
2026-09-09

Of the 2,547 infection recalls we have scored against our rubric, 31 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1,678 (66%) 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 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.

2501–2525 of 2547

  • SevereFDA (Drugs)·D-115-2013·2013-01-09

    New England Compounding Center Recalls Clonidine Vials Due to Sterility Concerns

    New England Compounding Center is recalling Clonidine 100 mcg/mL vials nationwide due to a lack of assurance of sterility.

    Product
    Clonidine 100 mcg/mL PF, 1mL and 2 mL vials, manufactured by New England Compounding Center, Framingham, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-114-2013·2013-01-09

    New England Compounding Center Recalls Bupivacaine Products Due to Sterility Concerns

    New England Compounding Center is recalling Bupivacaine 0.25%, 0.5%, and 0.75% PF products because the agency cannot assure the sterility of the medication.

    Product
    Bupivacaine 0.25% PF, Bupivacaine 0.5% PF, and Bupivacaine 0.75% PF, manufactured by New England Compounding Center, Framingham, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-112-2013·2013-01-09

    New England Compounding Center Recalls Betamethasone Repository Injections

    New England Compounding Center is recalling Betamethasone Repository injections due to a lack of assurance of sterility. The recall covers all lot codes distributed nationwide.

    Product
    Betamethasone Repository 6 mg/mL PF Injection and Betamethasone Repository 6 mg/mL P Injection, manufactured by New England Compounding Center, Framingham, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-096-2013·2012-12-26

    Hospira Recalls Nalbuphine Hydrochloride Injection Due to Sterility Concerns

    Hospira is recalling 145,400 vials of Nalbuphine Hydrochloride Injection because loose crimps and missing stoppers prevent assurance of sterility.

    Product
    NALBUPHINE HYDROCHLORIDE — NALBUPHINE HYDROCHLORIDE (NALBUPHINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0423-2013·2012-11-28

    King Systems Recalls Laryngeal Airway Devices Due to Sterilization Indicator Failure

    King Systems Corp. is recalling 2,630 laryngeal airway devices because sterilization indicators failed to change color, suggesting the devices may not be sterile.

    Product
    KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case Size 4 / Adult ClearSeal King LAD¿ Patient Size: 50-70kg Product Usage: Laryngeal airway
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0424-2013·2012-11-28

    King Systems Recalls Laryngeal Airway Devices Due to Sterilization Indicator Issues

    King Systems Corp. is recalling specific lots of Laryngeal Airway Devices because sterilization indicators failed to change color as expected, potentially indicating improper sterilization.

    Product
    KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case Size 5 / Adult ClearSeal King LAD¿ Patient Size: >70kg Product Usage: Laryngeal airway
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0090-2013·2012-10-24

    Osteotech Recalls Grafton and Xpanse Bone Graft Products Due to Sterility Concerns

    Osteotech is recalling multiple lots of Grafton and Xpanse bone graft products because the sterility of the inner pouch surface may be compromised.

    Product
    Grafton DBM Orthoblend Small Defect Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone matrix (DBM) allograft. It is intended for use as a bone graft extender, bone gra
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0028-2013·2012-10-17

    Remington Medical Recalls Sterile Prostate Biopsy Needles Due to Sterility Concerns

    Remington Medical Inc. is recalling 800 sterile automatic cutting needles for prostate biopsies because the product's sterility may be compromised.

    Product
    Automatic Cutting Needles, Soft Tissue Biopsy Needle, NAC-1820M, Sterile, Remington Medical, Inc., 5830 Meadowridge Court, Alpharetta, GA 30005. Prostate Biopsy Needles shall be single use only and are to be used by a Urologist in a healthcare setting to obtain needle biopsies
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2360-2012·2012-09-26

    Custom Medical Specialties Recalls Hysteroscopy Kits Due to Microbial Testing Failures

    Custom Medical Specialties is recalling BR980-9600 Hysteroscopy Sterile Procedure Kits because the included Povidone Iodine Prep Solution lacked required microbial testing and failed finished goods specifications.

    Product
    BR980-9600 Hysteroscopy Sterile Procedure Kit containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
    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-2327-2012·2012-09-19

    Bard Foley procedural trays recalled due to incomplete sterile seals

    C.R. Bard is recalling 56,694 units of Bard Foley procedural trays because the sterile packaging seals were incomplete.

    Product
    Bard Foley procedural trays packaged in breather bags. The product is packaged ten units in each shipper box, and are sold sterile for single use. Used to catheterize patients. The finished trays are sold in Tyvek breather bags.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2365-2012·2012-09-19

    Exactech Recalls Novation Modular Drill Bits Due to Sterility Issues

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

    Product
    REF 101-45-30***NOVATION MODULAR DRILL BIT LENGTH: 30mm, DIAMETER 4.5mm***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-2361-2012·2012-09-19

    Exactech Recalls Novation Modular Drill Bits Due to Sterility Concerns

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

    Product
    REF 101-05-20***NOVATION MODULAR DRILL BIT LENGTH: 20mm, DIAMETER 3.2mm***Use with 20mm 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-2363-2012·2012-09-19

    Exactech Recalls Novation Modular Drill Bits Due to Sterility Concerns

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

    Product
    REF 101-05-40***NOVATION MODULAR DRILL BIT LENGTH: 40mm, DIAMETER 3.2mm***Use with 40mm 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-2295-2012·2012-09-05

    Unimed Recalls Medline Electrosurgical Electrodes Due to Sterility Concerns

    Unimed Surgical Products is recalling Medline electrosurgical electrodes due to sterility concerns. The affected units are intended for cutting and coagulation of soft tissue.

    Product
    Product is labeled in part: "***MEDLINE***Standard PTFE Coated Blade with Extended Insulation 2.50 (6.40cm) Length***Reorder: ES0012M***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2288-2012·2012-09-05

    Unimed Recalls Medline Electrosurgical Electrodes Due to Sterility Concerns

    Unimed Surgical Products is recalling specific lots of Medline electrosurgical electrodes due to concerns regarding sterility.

    Product
    Product is labeled in part: "***MEDLINE***Extended PTFE Coated Needle with Extended Insulation 4.0" (10.16cm) Length***Reorder: ES0016AM***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1649-2012·2012-08-29

    Custom Medical Specialties Recalls Sterile Access Trays Due to Sterility Concerns

    Custom Medical Specialties is recalling 35 sterile access trays because they contain sodium chloride bags subject to a separate recall for leaking.

    Product
    Custom Access Tray, Sterile, contains Sodium Chloride 0.9% 50 mL, Re-order #: CMS-1667-R2(94-2478), Manufactured for KM Medical, Inc., 124 Jewett Street, Georgetown, MA 01833, the tray also contains other components not listed in this product description.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Drugs)·D-1515-2012·2012-08-22

    Franck's Lab Recalls Sterile Estradiol Drugs Due to Microbial Contamination

    Franck's Lab Inc. is recalling 72 units of sterile estradiol products distributed between November 2011 and May 2012 because FDA sampling found microorganisms in the clean room.

    Product
    ESTRADIOL 25MG PELLETS 1 PELLET, 15 PEL, 15 PELLET, 2 PELLET, 2 TAB, 3 PELLET, 4 PELLET, 6 PELL, 6 PELLET; ESTRADIOL 50MG PELLETS 1 PELELT, 1 PELLET, 4 PELLET, 6 PELLET; ESTRADIOL CYPIONATE 5MG/ML INJECTABLE 5 ML; ESTRADIOL VALERATE IN COTTONSEED OIL 40 MG/ML INJECTABLE 10 ML; ES
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1447-2012·2012-08-22

    Franck's Lab Recalls Acetazolamide Injectable Due to Sterility Concerns

    Franck's Lab Inc. is recalling Acetazolamide injectable vials because FDA sampling found microorganisms in the clean room where they were prepared.

    Product
    ACETAZOLAMIDE, LYOPHILIZED 500MG INJECTABLE10 VIAL, 4 VIAL, 5 VIAL, 6 VIAL, 8 VIAL (5 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1511-2012·2012-08-22

    Recall of Sterile Ophthalmic Drugs Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile ophthalmic drugs due to microbial contamination found in the clean room.

    Product
    EDETATE DISODIUM PF IN BSS 3% OPHTHALMIC 10 ML; EDETATE DISODIUM SOLUTION IN ARTIFICIAL TEARS 0.05% OPHTHALMIC 10 ML (2 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1464-2012·2012-08-22

    Franck's Lab Recalls Sterile Bevacizumab Drugs Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile bevacizumab injectables and ophthalmic products distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    BEVACIZUMAB & DXM, SDPF - (0.06ML SYRINGE, 31G, 5/16") 25MG/100MG/ML INJECTABLE 0.72 ML; BEVACIZUMAB & DXM, SDPF - (0.06ML SYRINGE, 31G, 5/16") 25MG/20MG/ML INJECTABLE 3 ML, 4.5 ML; BEVACIZUMAB & DXM, SDPF - (0.075ML SYRINGE, 30G, 1/2") 25MG/20MG/ML INJECTABLE 0.225 ML; BEVACIZU
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1638-2012·2012-08-22

    Franck's Compounding Lab Recalls Sterile Vancomycin Eye Drops

    Franck's Compounding Lab is recalling sterile vancomycin eye drops and injections due to microbial contamination found in the facility's clean room.

    Product
    VANCOMYCIN (INTRAOCULAR) OPHTHALMIC, P.F. (BSS) 0.4% (4MG/ML) (0.4MG/0.1ML) INJE 400 ML; VANCOMYCIN (INTRAOCULAR) OPHTHALMIC, P.F. 1MG/0.1ML (10MG/ML) INJECTABLE 0.1 ML 0.2 ML 1 ML 100 ML 150 ML 2 ML 2 MLS 5 ML 50 ML 6 ML
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1474-2012·2012-08-22

    Franck's Lab Recalls Sterile Bupivacaine and Fentanyl Intrathecal Solutions

    Franck's Lab Inc. is recalling sterile bupivacaine and fentanyl intrathecal solutions due to microbial contamination found in the clean room.

    Product
    BUPIVACAINE/FENTANYL IN SODIUM CHLORIDE 0.9% P. F. 30 MG/200 MCG/ML INTRATHECAL 40 ML (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1478-2012·2012-08-22

    Franck's Lab Recalls Sterile Intrathecal Bupivacaine and Morphine Sulfate Mixtures

    Franck's Lab Inc. is recalling four sterile intrathecal drug mixtures because FDA sampling found microorganisms and fungal growth in the clean room where they were prepared.

    Product
    BUPIVACAINE/MORPHINE SULFATE, P.F. 2.5MG/10MG/ML INTRATHECAL 40 ML; BUPIVACAINE/MORPHINE SULFATE, P.F. 7.5MG/25MG/ML INTRATHECAL 20 ML; BUPIVACAINE/MORPHINE SULFATE, P.F. 7.5MG/50MG/ML INTRATHECAL 18 ML, 35 ML (4 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide