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.

1651–1675 of 3429

  • 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-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-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-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-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-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-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-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 contami
    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-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
  • 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-0213-2019·2018-11-07

    Pharm D Solutions Recalls Testosterone Injectable Due to Sterility Concerns

    Pharm D Solutions is recalling Testosterone in Grapeseed Oil Injectable because the product lacks assurance of sterility. The recall covers multiple vial sizes distributed nationwide.

    Product
    Testosterone in Grapeseed Oil 200 mg/mL, a) 4 mL, b) 5 mL, c) 10 mL and d) 30 mL Injectable, Pharm D Solutions, Houston, Texas NDC 69699-1702-05
    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-0182-2019·2018-11-07

    Pharm D Solutions Recalls Sermorelin/GHRP-2 Powder Due to Sterility Concerns

    Pharm D Solutions is recalling 330 vials of Sermorelin/GHRP-2 Powder because the company cannot ensure the product is sterile.

    Product
    Sermorelin/GHRP-2 9 mg-6 mg Powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1728-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0249-2019·2018-10-31

    Custom Healthcare Systems Recalls Vaginal Speculums Due to Sterility Compromise

    Custom Healthcare Systems is recalling vaginal speculums because incorrect sealing specifications compromised product sterility.

    Product
    (1)CHS Custom Convenience Kit-VAGINAL SPECULUM (SMALL) Product Number:D36-16267 (2) CHS Custom Convenience KitVAGINAL SPECULUM (LARGE) Product Code: D36-16269
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0266-2019·2018-10-31

    Custom Healthcare Systems Recalls Non-Sterile Convenience Gowns

    Custom Healthcare Systems is recalling 72,832 units of convenience gowns because they were sealed with incorrect specifications, compromising sterility.

    Product
    CHS Custom Convenience (1) 1231-150L GOWN, RAGLAN, LG, NONREINF (2) 1231-150XL GOWN, RAGLAN, XL, NONREINF (3) 1231-140XL GOWN, SPECIALTY XL, XLONG
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0255-2019·2018-10-31

    Custom Healthcare Systems Recalls Sterility-Compromised Connector Packs

    Custom Healthcare Systems is recalling 150 units of CHS Custom Convenience Kit-CONNECTOR PACK due to incorrect sealing specifications that compromised product sterility.

    Product
    CHS Custom Convenience Kit-CONNECTOR PACK Product Number:D36-7520
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0267-2019·2018-10-31

    CHS Custom Convenience Kits Recalled Due to Sterility Compromise

    Custom Healthcare Systems is recalling 4,500 fenestrated drape kits because incorrect sealing specifications compromised product sterility.

    Product
    CHS Custom Convenience Kit-FENESTRATED DRAPE 40 X 62P Part Number: 1222-2112
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0263-2019·2018-10-31

    Custom Healthcare Systems Recalls Convenience Kits Due to Sterility Compromise

    Custom Healthcare Systems is recalling 60 units of CHS Custom Convenience Kits because incorrect sealing specifications compromised product sterility.

    Product
    CHS Custom Convenience Kit-TUBING W. CONNECTOR Product Number:UNC-10884
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0245-2019·2018-10-31

    Custom Healthcare Systems Recalls Cast Padding Kits Due to Sterility Compromise

    Custom Healthcare Systems is recalling 30 units of cast padding kits because incorrect sealing specifications compromised product sterility.

    Product
    CHS Custom Convenience Kit-SPECIALIST¿ CAST PADDING 3" X 4 YDS) Product Number:D4-324SCP
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0232-2019·2018-10-31

    Ecolab Camera Arm Drapes Recalled for Potential Sterility Breach

    Ecolab is recalling specific lots of Camera Arm Drapes because wrinkles in the packaging seal could compromise the product's sterility.

    Product
    Camera Arm Drape (Box of 20) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vinci Si Robotic system / Distributed by Intuitive Surgical Product Usage: Microtek Medical Equipment Drapes are intended to cover/wrap vario
    Category
    Medical Device
    Distribution
    Distributed nationwide