The Recall Desk

Hazard

Infection Risk recalls

3,429 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
3,429
Critical
25
Severe
988
Most recent
2026-09-03

Of the 3,429 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 988 (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.

3376–3400 of 3429

  • HighFDA (Drugs)·D-1675-2012·2012-09-26

    Dukal Recalls ZEE Antiseptic Wipes Due to Microbial Contamination

    Dukal Corp. is recalling ZEE Antiseptic Wipes due to contamination with Burkholderia cepacia. The affected products were distributed nationwide.

    Product
    ZEE Antiseptic Wipes, First Aid Antiseptic, Benzalkonium chloride 0.133% (effective concentration), over the counter; supplied in 10 (item 2633), 50 (items 0204 and 02040 [sold in Canada only]) and 100 (item 0271) wipes per box distributed by ZEE MEDICAL, INC., Irvine, CA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2372-2012·2012-09-19

    Omni Life Science Recalls Apex Knee System Modular Tibia Augments

    Omni Life Science is recalling 310 Apex Knee System Modular Tibia Augments because the sterile pouches may breach, compromising the device's sterility.

    Product
    Omnilife Science Apex Knee System Modular Tibia Augment, Size 3 x 4mm Ref: KC-54030. The Apex Knee System is intended for use as a primary or revision total knee replacement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2374-2012·2012-09-19

    Omni Life Science Apex Knee System Modular Tibia Augment Recall

    Omni Life Science is recalling 182 units of the Apex Knee System Modular Tibia Augment because the sterile pouches may breach, compromising sterility.

    Product
    Omnilife Science Apex Knee System Modular Tibia Augment, Size 5 x 4mm Ref: KC-54050. The Apex Knee System is intended for use as a primary or revision total knee replacement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2375-2012·2012-09-19

    Omnilife Apex Knee System Modular Tibia Augment Recalled for Sterility Breach

    Omni Life Science is recalling 36 units of Apex Knee System Modular Tibia Augments because the sterile packaging may breach, compromising sterility.

    Product
    Omnilife Science Apex Knee System Modular Tibia Augment, Size 6 x 4mm Ref: KC-54060. The Apex Knee System is intended for use as a primary or revision total knee replacement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2371-2012·2012-09-19

    Omni Life Science Recalls Apex Knee System Modular Tibia Augments

    Omni Life Science is recalling 286 Apex Knee System Modular Tibia Augments because the sterile pouches may breach, compromising sterility.

    Product
    Omnilife Science Apex Knee System Modular Tibia Augment, Size 2 x 4mm Ref: KC-54020. The Apex Knee System is intended for use as a primary or revision total knee replacement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2373-2012·2012-09-19

    Omni Life Science Apex Knee System Modular Tibia Augment Recalled for Sterility Breach

    Omni Life Science is recalling 270 Apex Knee System Modular Tibia Augments because the sterile pouches may breach, compromising sterility.

    Product
    Omnilife Science Apex Knee System Modular Tibia Augment, Size 4 x 4mm Ref: KC-54040. The Apex Knee System is intended for use as a primary or revision total knee replacement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2370-2012·2012-09-19

    Omni Life Science Recalls Apex Knee System Tibia Augments

    Omni Life Science is recalling 312 Apex Knee System Modular Tibia Augments because the sterile pouches may breach, compromising sterility.

    Product
    Omnilife Science Apex Knee System Modular Tibia Augment, Size 1 x 4mm Ref: KC-54010. The Apex Knee System is intended for use as a primary or revision total knee replacement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2364-2012·2012-09-19

    Exactech Recalls Novation Modular Drill Bits for 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 101-45-20***NOVATION MODULAR DRILL BIT LENGTH: 20mm, DIAMETER 4.5mm***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-2366-2012·2012-09-19

    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 101-45-40***NOVATION MODULAR DRILL BIT LENGTH: 40mm, DIAMETER 4.5mm***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
  • SevereFDA (Drugs)·D-1665-2012·2012-09-05

    Bracco Recalls Multihance Injection Due to Sterility Concerns

    Bracco Diagnostics is recalling 4,870 vials of Multihance injection because aluminum crimp caps may displace during use, compromising sterility.

    Product
    MULTIHANCE — MULTIHANCE (GADOBENATE DIMEGLUMINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2296-2012·2012-09-05

    Unimed Recalls Medline Electrosurgical Electrodes Due to Sterility Concerns

    Unimed Surgical Products is recalling Medline electrosurgical electrodes due to sterility concerns. The affected units were distributed nationwide in the US.

    Product
    Product is labeled in part: "***MEDLINE***Extended PTFE Coated Blade with Extended Insulation 6.5 (16.51cm) Length***Reorder: ES0014M***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-2286-2012·2012-09-05

    Medline Extended PTFE Needle Recall for Sterility Concerns

    Unimed Surgical Products is recalling Medline Extended PTFE Needles due to sterility concerns. The recall affects 1,440 units distributed nationwide.

    Product
    Product is labeled in part: "***MEDLINE***Extended PTFE Needle 6.5" (16.51cm) Length***Reorder: ES0016***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of Medline
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1526-2012·2012-08-22

    Franck's Lab Recalls Sterile Ganciclovir Injectable Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile Ganciclovir injectable syringes because FDA testing found microorganisms and fungal growth in the clean room where the drugs were prepared.

    Product
    GANCYCLOVIR, SDPF - (30G, 1/2" SYRINGE) 20MG/ML INJECTABLE 1 ML (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1578-2012·2012-08-22

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

    Franck's Lab Inc. is recalling sterile injectable drugs distributed between November 2011 and May 2012 after FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    MEYERS COCKTAIL INJECTABLE 30 ML; MEYERS COCKTAIL (DR. MORENO) INJECTABLE 90 ML; MEYERS COCKTAIL/ CALCIUM/VIT B1/ METHYLCOBALAMIN 1GM/5MG/1000MCG/500ML INJECTAB 250 ML 5 ML (4 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1557-2012·2012-08-22

    Franck's Lab Recalls Levothyroxine Sodium Injectable Due to Sterility Concerns

    Franck's Lab Inc. is recalling Levothyroxine Sodium Injectable due to microorganisms and fungal growth found in the clean room where sterile products were prepared.

    Product
    LEVOTHYROXINE SODIUM 325MCG/ML (0.325MG/ML) INJECTABLE 15 ML (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1453-2012·2012-08-22

    Recall of Sterile Alteplase Syringes Due to Microbial Contamination

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

    Product
    ALTEPLASE, SDPF - (0.05ML SYRINGE, 30G, 1/2") 1000MCG/ML INJECTABLE 0.05 ML; ALTEPLASE, SDPF - (0.15ML LL SYRINGE, NO NEEDLE) 100MCG/ML (10MCG/0.1ML) INJECTA 0.15 ML, 0.3 ML; ALTEPLASE, SDPF - (0.1ML SYRINGE, 30G, 1/2") 1000MCG/ML INJECTABLE 0.1 ML, 0.2 ML, 0.3 ML; ALTEPLASE, SD
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1582-2012·2012-08-22

    Franck's Lab Recalls Sterile Injectable Drugs Due to Contamination

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

    Product
    MITOMYCIN/BUPIVACAINE WITH EPI 1:200,000 0. 04MG/0.5% PER 0.3ML SYR INJECTABLE 3 ML (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1594-2012·2012-08-22

    Franck's Lab Recalls Sterile Papaverine and Alprostadil Injectable Drugs

    Franck's Lab Inc. is recalling sterile papaverine and alprostadil injectables distributed between November 2011 and May 2012 due to microbial contamination found in the clean room.

    Product
    PAPAVERINE/ALPROSTADIL 30MG/10MCG/ML INJECTABLE 10 ML; PAPAVERINE/ALPROSTADIL 30MG/15MCG/ML INJECTABLE 10 ML (2 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1534-2012·2012-08-22

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

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

    Product
    HYALURONIDASE - PRESERVATIVE FREE 150 U/ML INJECTABLE 1 MLS, 10 MLS, 100 MLS, 12 MLS, 12.5 ML, 120 MLS, 15 MLS, 16 ML, 16 MLS, 2 MLS, 20 ML, 20 MLS, 24 MLS, 25 ML, 30 ML, 30 MLS, 36 MLS, 4 MLS, 40 MLS, 44 ML, 5 MLS, 50 ML, 50 MLS, 6 ML, 6 MLS, 60 MLS, 8 MLS, 80 MLS, 9 ML; HYALUR
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1623-2012·2012-08-22

    Franck's Lab Recalls Sterile Tetracosactide Acetate Injectable Due to Contamination

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

    Product
    TETRACOSACTIDE ACETATE (COSYNTROPIN) 0.25MG/ML INJECTABLE 1 ML (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1558-2012·2012-08-22

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

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

    Product
    LIDOCAINE HCL (STERILE) 4% JELLY 120 ML 30 ML; LIDOCAINE HCL 4% SOLUTION 200 ML 300 ML 500 ML 600 ML; LIDOCAINE HCL 1% INJECTABLE 100 ML 1000 ML 1200 ML 1250 ML 150
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1579-2012·2012-08-22

    Franck's Compounding Lab Recalls Sterile Injectable Drugs Due to Contamination

    Franck's Compounding Lab is recalling sterile injectable drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    MIC - COMBO WITH METHYLCOBALAMIN 0.8/1.6/1.6/0.0001/0.03% INJECTABLE 10 ML 150 ML 30 ML; MIC COMBO + CHORIONIC GONADOTROPIN + B12 500U/40MCG/ML (125U/10MCG/0.25ML) INJEC 6 ML; MIC COMBO + CHORIONIC GONADOTROPIN, LYOPHILIZED 10,000 UNIT VIAL INJECTABLE 1 VIAL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1524-2012·2012-08-22

    Franck's Lab Recalls Forskolin/Phentolamine Injectable Due to Sterility Concerns

    Franck's Lab Inc. is recalling Forskolin/Phentolamine injectable units because FDA sampling found microorganisms and fungal growth in the clean room where the sterile drugs were prepared.

    Product
    FORSKOLIN/PHENTOLAMINE 200MCG / 2MG INJECTABLE 5 ML (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1477-2012·2012-08-22

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

    Franck's Lab Inc. is recalling sterile injectable drugs containing bupivacaine, lidocaine, and methylprednisolone because FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    BUPIVACAINE/LIDOCAINE/METHYLPREDNISOLONE 0.17% / 0.67% / 2.7% INJECTABLE 15 ML, 18.75 ML, 26.25 ML, 37.5 ML, 45 ML; BUPIVACAINE/LIDOCAINE/METHYLPREDNISOLONE 0.22% / 0.88% / 0.88% INJECTABLE 450 ML, 900 ML (7 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide