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.

1651–1675 of 3438

  • SevereFDA (Drugs)·D-0352-2019·2019-01-16

    Heritage Pharmaceuticals Recalls Cidofovir Injection Due to Sterility Concerns

    Heritage Pharmaceuticals is recalling Cidofovir Injection vials due to complaints about dried powder on the outside of the bottles, which raises concerns about sterility.

    Product
    Cidofovir Injection 375mg/5mL (75mg/mL) vial injection. 5 mL vials, Rx only, Mfd by: Emcure Pharmaceuticals Ltd., Hinjawadi, Pune, India Mfg. for : Heritage Pharmaceuticals Inc. NDC 23155-0216-31
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0351-2019·2019-01-16

    Baxter Recalls Dianeal Low Calcium Dialysis Solution Due to Sterility Concerns

    Baxter Healthcare is recalling 29,370 bags of Dianeal Low Calcium peritoneal dialysis solution because confirmed customer complaints identified leaks in the tubing, compromising sterility.

    Product
    DIANEAL LOW CALCIUM WITH DEXTROSE — DIANEAL LOW CALCIUM WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0398-2019·2019-01-09

    Northwest Compounding Pharmacy Recalls Lidocaine/Epinephrine Liquid Due to Sterility Concerns

    Northwest Compounding Pharmacy is recalling Lidocaine/Epinephrine liquid 1%/1:1000 in 50 ml glass vials due to a lack of sterility assurance. The product was distributed in Oregon to medical facilities and patients.

    Product
    Lidocaine/Epinepherine liquid 1%/ 1:1000, RX, glass vial These include injectable medications, sterile solutions, eye drops, and eye ointments
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-0681-2019·2019-01-02

    Medical Action Industries Recalls Laparotomy Sponges Due to Sterility Compromise

    Medical Action Industries is recalling 2,600 laparotomy sponges because a breach of the sterile barrier may have compromised product sterility.

    Product
    Laparotomy Sponge, XR No Loop, Single-Use, Sterile, 18'' x 18'' pre-washed with bands without handles, 5 sponges/pack, 40 packs/case. X-Ray Detectable, 1 Non-Absorbent outer wrap. intended use: Laparotomy sponges are intended for use inside the body, surgical incision, or for…
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0654-2019·2018-12-26

    Bracco Recalls Empower FastLoad CT Syringe Packs Due to Seal Defect

    Bracco is recalling 33,350 Empower FastLoad CT Syringe Packs because an insufficient seal on the sterile barrier may compromise the device's sterility.

    Product
    Empower FastLoad CT Syringe Pack -sterile disposable syringe kit for use with the EmpowerCT¿, EmpowerCTA¿ and EmpowerCTA¿+ Injector Systems SKU 017344/6720 Empower FastLoad" CT Syringe Pack is a sterile, disposable syringe kit designed for use with EmpowerCT¿, EmpowerCTA¿…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0533-2019·2018-12-12

    Zimmer Biomet Recalls Guide Wires Due to Sterility Compromise

    Zimmer Biomet is recalling 2,080 units of ZMS Intramedullary Fixation Smooth Guide Wires because creases in the packaging may compromise sterility.

    Product
    Zimmer ZMS¿ Intramedullary Fixation Smooth Guide Wire, 2.4 mm Diameter, 100 cm Length Item Number: 47-2237-033-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0532-2019·2018-12-12

    Zimmer Biomet Recalls Humeral Guide Wires Due to Sterility Compromise

    Zimmer Biomet is recalling 780 Humeral Guide Wires because creases in the packaging may compromise sterility. The product is a single-use surgical instrument.

    Product
    Zimmer M/DN¿ Intramedullary Fixation Humeral Guide Wire - Bullet Tip, 2.4 mm Diameter, 70 cm Length Item Number: 00-2255-026-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0538-2019·2018-12-12

    Zimmer Biomet Recalls Natural Nail System Guide Wires Due to Sterility Compromise

    Zimmer Biomet is recalling 57,241 Natural Nail System Tear Drop Guide Wires because creases in the sealing area may compromise product sterility.

    Product
    Zimmer Natural Nail¿ System - Tear Drop Guide Wire, 3.0 mm Diameter, 100 cm Length Item Number: 47-2490-097-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0542-2019·2018-12-12

    Zimmer Biomet Recalls Pressure Sentinel Guide Wires Due to Sterility Compromise

    Zimmer Biomet is recalling 1,676 Pressure Sentinel Guide Wires because creases in the packaging seal may compromise sterility. The defect could increase the risk of infection during orthopaedic surgery.

    Product
    Zimmer Pressure Sentinel¿ Intramedullary Reaming System, Guide Wire, Bullet Tip, 2.4 mm Diameter Item Number: 00-2228-024-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0560-2019·2018-12-12

    Atrium Medical Recalls 28Fr Thoracic Catheters Due to Seal Defect

    Atrium Medical Corporation is recalling 2,930 units of 28Fr PVC Thoracic Catheters due to a seal defect in sterile barrier pouches that could compromise sterility.

    Product
    Atrium 28Fr PVC Thoracic Catheter RIGHT ANGLE, Part No. 8128
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0534-2019·2018-12-12

    Zimmer Biomet Recalls Guide Wires Due to Sterility Compromise

    Zimmer Biomet is recalling 9,387 units of ZMS Intramedullary Fixation Smooth Guide Wires because creases in the sealing area compromise product sterility.

    Product
    Zimmer ZMS¿ Intramedullary Fixation Smooth Guide Wire, 3.0 mm Diameter, 100 cm Length Item Number: 47-2237-037-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0525-2019·2018-12-12

    ASO Recalls Family Wellness Sterile Gauze Pads Due to Sterilization Concerns

    ASO, LLC is recalling Family Wellness First Aid Sterile Gauze Pads because they may not be fully sterilized. The affected units were distributed nationwide to ten states.

    Product
    Family Wellness First Aid Sterile Gauze Pad 3 in x 3 in, 10 CT. White, bleached, non-woven, rayon/polyester sterile Gauze Pad 3 inch x 3 inch, 12-ply 10 count cardboard box
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0535-2019·2018-12-12

    Zimmer Biomet Recalls Guide Wires Due to Sterility Compromise

    Zimmer Biomet is recalling ZMS Intramedullary Fixation Smooth Guide Wires because creases in the sealing area may compromise product sterility.

    Product
    Zimmer ZMS¿ Intramedullary Fixation Smooth Guide Wire - Bullet Tip, 3.0 mm Diameter, 100 cm Length Item Number: 47-2237-038-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0530-2019·2018-12-12

    Zimmer Biomet Recalls Pressure Sentinel Guide Wires Due to Sterility Compromise

    Zimmer Biomet is recalling Pressure Sentinel Guide Wires because creases in the sealing area compromise product sterility. The recall affects 48,320 units distributed worldwide.

    Product
    Zimmer Pressure Sentinel¿ Intramedullary Reaming System, Guide Wire, Bullet Tip, 2.4 mm Diameter Item Number: 00-2228-024-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0537-2019·2018-12-12

    Zimmer Biomet Recalls Smooth Guide Wires Due to Sterility Compromise

    Zimmer Biomet is recalling Smooth Guide Wires because creases in the sealing area may compromise product sterility. The recall affects 48,320 units distributed worldwide.

    Product
    Zimmer Smooth Guide Wire - Bullet Tip, 3.0 mm Diameter, 100 cm Length Item Number: 47-2255-008-01 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0540-2019·2018-12-12

    Zimmer Biomet Recalls Natural Nail System Guide Wires Due to Sterility Concerns

    Zimmer Biomet is recalling 12,724 units of Natural Nail System Tear Drop Guide Wires because creases in the packaging may compromise sterility.

    Product
    Zimmer Natural Nail¿ System - Tear Drop Guide Wire, 3.0 mm Diameter, 70 cm Length Item Number: 47-2490-098-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0473-2019·2018-11-28

    LeMaitre Vascular Recalls Unsealed Polyurethane Carotid Shunts

    LeMaitre Vascular is recalling 46 units of Pruitt F3-S Polyurethane Outlying Carotid Shunts because the pouches are not sealed, compromising sterility.

    Product
    LeMaitre Vascular Pruitt F3¿-S Polyurethane Outlying Carotid Shunt, Sterile Model # 2014-10
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0456-2019·2018-11-21

    American Contract Systems Recalls Powdered Surgical Gloves

    American Contract Systems is recalling 1,180 kits of powdered surgical gloves because they are an FDA banned substance.

    Product
    Powdered Surgical Gloves, labeled as: a. Baxter and Ansell brand Powdered Surgical Gloves b. Powdered Surgical Gloves included in ACS surgical convenience kits Health care personnel rely on medical gloves as barriers against transmission of infectious diseases and…
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Drugs)·D-0233-2019·2018-11-14

    Qualgen Recalls Testosterone Pellets Due to Sterility Assurance Concerns

    Qualgen, LLC is recalling specific lots of Testosterone 200mg pellets nationwide due to a lack of assurance of sterility.

    Product
    Testosterone 200mg pellet, 1 count (NDC 69761-120-01), 6 count (NDC 69761-120-06), 12 count (NDC 69761-120-12), and 30 count (NDC 69761-120-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0234-2019·2018-11-14

    Qualgen Recalls Testosterone Pellets Due to Sterility Concerns

    Qualgen, LLC is recalling specific lots of Testosterone 25 mg pellets nationwide because the company lacks assurance of sterility for these products.

    Product
    Testosterone 25 mg pellet, 1 count (NDC: 69761-125-01) and 30 count vials (NDC: 69761-125-30), Rx Only Qualgen, LLC, Edmond, OK 73013
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0139-2019·2018-11-07

    Pharm D Solutions Recalls Beta-Complex Injectable Due to Sterility Concerns

    Pharm D Solutions is recalling Beta-complex B-1, B-6, B-3, B-12, B-5 100, 2.54 Injectable due to lack of assurance of sterility. The product was distributed nationwide.

    Product
    Beta-complex B-1, B-6, B-3, B-12, B-5 100, 2.54 Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1611-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0166-2019·2018-11-07

    Pharm D Solutions Recalls Lipo MIC-12 Compound Injectable Due to Sterility Concerns

    Pharm D Solutions is recalling Lipo MIC-12 Compound Injectable vials nationwide due to a lack of assurance of sterility.

    Product
    Lipo MIC-12 Compound Injectable a) NDC 69699-1603-10; b) 30 mL Stock Solution Compound Injectable NDC 69699-1603-30, Pharm D Solutions, Houston, Texas
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0153-2019·2018-11-07

    Pharm D Solutions Recalls Glutamine Solution Due to Sterility Concerns

    Pharm D Solutions is recalling Glutamine 10 mg/mL Solution because the product lacks assurance of sterility. The recall covers specific lots distributed nationwide.

    Product
    Glutamine 10 mg/mL Solution, Pharm D Solutions, Houston, Texas ---- NDC 69699-1439-59
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0168-2019·2018-11-07

    Pharm D Solutions Recalls Methylcobalamin Injectable Due to Sterility Concerns

    Pharm D Solutions is recalling specific lots of Methylcobalamin 1 mg/mL injectable because the company cannot ensure the product is sterile.

    Product
    Methylcobalamin 1 mg/mL a) 10 mL Injectable NDC 69699-1501-10; b) 30 mL Injectable NDC 69699-1501-30, Pharm D Solutions, Houston, Texas
    Category
    Drug
    Distribution
    Distributed nationwide