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.

1701–1725 of 3429

  • HighFDA (Devices)·Z-0154-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues

    Zimmer Biomet is recalling 16 Affixus Hip Fracture Nails because complaints indicated the sterile packaging was already open when the products were opened in surgery.

    Product
    Affixus Hip Fracture Nail Left 125 13 mm x 260 mm, Item Number 814413260 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0164-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defects

    Zimmer Biomet is recalling 19 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and abroad.

    Product
    Affixus Hip Fracture Nail Left 130 9 mm x 360 mm, Item Number 814609360 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0155-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defect

    Zimmer Biomet is recalling 31 Affixus Hip Fracture Nails because sterile packaging was found open during surgery.

    Product
    Affixus Hip Fracture Nail Left 125 13 mm x 340 mm, Item Number 814413340 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0156-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues

    Zimmer Biomet is recalling 32 Affixus Hip Fracture Nails because complaints indicated the sterile packaging was already open when the product was opened in surgery.

    Product
    Affixus Hip Fracture Nail Left 125 13 mm x 360 mm, Item Number 814413360 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0160-2019·2018-10-24

    Recall of Affixus Hip Fracture Nail Over Sterility Issue

    Zimmer Biomet is recalling the Affixus Hip Fracture Nail because sterile packaging was found already open during surgery. The affected lot was distributed in the US and internationally.

    Product
    Affixus Hip Fracture Nail Right 130 11 mm x 340 mm, Item Number 814511340 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0122-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues

    Zimmer Biomet is recalling 153 Affixus Hip Fracture Nails because complaints indicated the sterile packaging was already open when the product was opened in surgery.

    Product
    Affixus Hip Fracture Nail 125 9 mm x 180 mm, Item Number 814309180 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0153-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defects

    Zimmer Biomet is recalling 68 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and two foreign countries.

    Product
    Affixus Hip Fracture Nail Left 125 11 mm x 360 mm, Item Number 814411360 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0136-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues

    Zimmer Biomet is recalling 20 Affixus Hip Fracture Nails because complaints indicated the sterile packaging was already open when the product was opened in surgery.

    Product
    Affixus Hip Fracture Nail Right 125 11 mm x 440 mm, Item Number 814311440 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0016-2019·2018-10-10

    Kerlix Bandage Roll Recalled for Potential Sterility Breach

    COVIDIEN LLC is recalling Kerlix Bandage Rolls due to a potential seal defect that could compromise product sterility.

    Product
    Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0015-2019·2018-10-10

    Kerlix Gauze Rolls Recalled for Potential Sterility Breach

    COVIDIEN LLC is recalling Kerlix Gauze Rolls due to a potential seal defect that could compromise sterility.

    Product
    Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0013-2019·2018-10-10

    Kerlix AMD Antimicrobial Bandage Roll Recalled for Sterility Breach Risk

    Coviden LLC is recalling Kerlix AMD Antimicrobial Bandage Rolls due to a potential seal defect that could compromise product sterility.

    Product
    Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0017-2019·2018-10-10

    COVIDIEN Dermacea Gauze Fluff Roll Recalled for Sterility Breach Risk

    COVIDIEN LLC is recalling Dermacea Gauze Fluff Rolls due to a potential seal defect that could compromise product sterility.

    Product
    Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0011-2019·2018-10-10

    Ellex iScience Recalls Canaloplasty Microcatheter Kits Due to Sterility Failure

    Ellex iScience is recalling 90 units of the iTRACK 250A Canaloplasty Microcatheter Kit because a sterility failure was found in one unit of the lot.

    Product
    ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0014-2019·2018-10-10

    Kerlix Bandage Rolls Recalled for Potential Sterility Breach

    COVIDIEN LLC is recalling Kerlix Bandage Rolls due to a seal defect that may compromise sterility. The recall covers 2,730,821 units distributed nationwide.

    Product
    Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0018-2019·2018-10-10

    COVIDIEN Dermacea Gauze Fluff Rolls Recalled for Sterility Breach Risk

    COVIDIEN LLC is recalling Dermacea Gauze Fluff Rolls due to a potential seal defect that could compromise sterility.

    Product
    Dermacea Gauze Fluff Roll, 6 Ply, 4 x 4-1/8 yd (10.2 cm x 3.7 m), REF 441106 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1163-2018·2018-09-05

    Auro Pharmacies Recalls Testosterone Injectable Due to Sterility Concerns

    Auro Pharmacies is recalling 43 vials of Testosterone Cypionate/Enanthate injectable because inadequate processes and equipment failed to assure product sterility.

    Product
    Testosterone Cypionate/Enanthate injectable, 126/54 mg/mL, packaged in a) 3 mL and b) 5 mL Multiple Dose vials, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1157-2018·2018-09-05

    Auro Pharmacies Recalls Calcium Gluconate Injectable Due to Sterility Concerns

    Auro Pharmacies is recalling 167 vials of Calcium Gluconate injectable because processes and equipment were inadequate to assure sterility.

    Product
    Calcium Gluconate injectable, 10%, 50 ml Single Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1158-2018·2018-09-05

    Auro Pharmacies Recalls Dexpanthenol Injectable Vials Due to Sterility Concerns

    Auro Pharmacies, Inc. is recalling 91 vials of Dexpanthenol injectable due to inadequate processes and equipment to assure sterility.

    Product
    Dexpanthenol injectable, 250 mg/mL, 10 mL Single Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1164-2018·2018-09-05

    Auro Pharmacies Recalls Testosterone Cypionate/Enanthate Injectable Due to Sterility Concerns

    Auro Pharmacies is recalling 32 vials of Testosterone Cypionate/Enanthate injectable because inadequate processes and equipment failed to assure the sterility of the product.

    Product
    Testosterone Cypionate/Enanthate injectable, 200/50 mg/mL, packaged in a) 5 mL and 8 mL Multiple Dose vials, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1165-2018·2018-09-05

    Auro Pharmacies Recalls Testosterone Enanthate/Cypionate Injectable Due to Sterility Concerns

    Auro Pharmacies is recalling 11 vials of Testosterone Enanthate/Cypionate injectable because the manufacturer could not assure the sterility of the product.

    Product
    Testosterone Enanthate/Cypionate injectable, 126/54 mg/mL, packaged in a) 3 mL and b) 5 mL Multiple Dose vials, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2884-2018·2018-08-29

    Stryker T2 Orthopedic Nails Recalled for Incomplete Sterility Seal

    Stryker GmbH is recalling 38 T2 orthopedic nails due to incomplete Tyvek lid seals that may compromise sterility.

    Product
    Stryker T2 ANKLE ARTHRODESIS NAIL RIGHT 10MMX200MM Item Number: 1819-1020S T2 ANKLE ARTHRODESIS NAIL RIGHT 12MMX200MM 1819-1220S T2 LONG PROXIMAL HUMERAL NAIL LEFT 240mm1832-2824S T2 LONG PROXIMAL HUMERAL NAIL LEFT 280mm 1832-2828S T2 LONG PROXIMAL HUMERAL NAIL RIGHT 260mm 18
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2819-2018·2018-08-22

    Arrow Hands-Off Central Venous Catheter Recalled for Packaging Seal Issues

    Arrow International is recalling 5,507 units of Hands-Off Multi-Lumen Central Venous Catheters because packaging may not be sealed, potentially compromising sterility.

    Product
    HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath Introducer System, Material HO-14703 The central venous catheter permits venous access to the central circulation through an indwelling Arrow percutaneous she
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2744-2018·2018-08-22

    ConvaTec AbViser AutoValve IAP Monitoring Devices Recalled for Sterile Barrier Breach

    ConvaTec is recalling AbViser AutoValve IAP Monitoring Devices because bubble leak testing confirmed a potential pinhole breach in the sterile barrier.

    Product
    AbViser AutoValve IAP (intra- abdominal pressure) Monitoring Device, Patient mount: a) REF ABV300, b) REF ABV301 AbViser is a sterile non-invasive disposable intra- abdominal pressure monitoring device containing aspiration tubing, infusion tubing, valves and optional pressur
    Category
    Medical Device
    Distribution
    Distributed nationwide