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.

2326–2350 of 3429

  • HighFDA (Devices)·Z-0234-2017·2016-10-26

    Windstone Medical Recalls Major Lithotomy Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling Major Lithotomy Packs because the included Medtronic gloves may have splits or holes that compromise sterility.

    Product
    Major Lithotomy Pack, kit number 002641-5 and 002641-6 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0232-2017·2016-10-26

    Windstone Medical Packaging Recalls Major Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 175 Major Kits (PHC1307A) because the Medtronic gloves inside may have splits or holes that compromise sterility.

    Product
    Major Kit, Kit number PHC1307(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0212-2017·2016-10-26

    Windstone Medical Knee Packs Recalled for Potential Sterility Compromise

    Windstone Medical is recalling 30 Knee Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Knee Pack, Kit number AMS4211 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0184-2017·2016-10-26

    Windstone Medical Packaging Recalls Extremity Pack-N Brunswick Kits

    Windstone Medical Packaging is recalling 290 units of Extremity Pack-N Brunswick kits because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Extremity Pack-N Brunswick, kit number PSS1866(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0153-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because they may contain splits or holes that compromise sterility.

    Product
    Bleph Pack, Kit part number AMS3325 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0235-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because splits or holes may compromise sterility in custom surgical kits.

    Product
    Major Ortho Pack, kit number 002647-12 and 002647-13 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0284-2017·2016-10-26

    Windstone Medical Packaging Recalls Virginia Custom Pack Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling Virginia Custom Pack kits because the included Medtronic gloves may have splits or holes that compromise sterility.

    Product
    Virginia Custom Pack, Kit number RMS1744 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0208-2017·2016-10-26

    Windstone Medical Recalls Hernia Packs With Defective Gloves

    Windstone Medical Packaging is recalling 765 Hernia Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Hernia Pack, Kit number AMS1519 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0236-2017·2016-10-26

    Windstone Medical Packaging Recalls Surgical Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 64 surgical kits because Medtronic gloves inside may have splits or holes, compromising sterility.

    Product
    Major Pack, Kit Number PSS3516 and PSS3516(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0165-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Medtronic is recalling disposable gloves included in Windstone Medical custom surgical kits because splits or holes may compromise sterility.

    Product
    Custom Pack, Kit numbers PSS1300, PSS1471(A, PSS1771, PSS2135(A, PSS2135(B, PSS2207, PSS2412(B, PSS2798, PSS2798(A, PSS2798(B, PSS3054, PSS3463, TVS4011NI(J, TVS4028(A, and TVS4070. convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0179-2017·2016-10-26

    Windstone Medical Recalls Surgical Procedure Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 666 Dr. Newman Surgical Procedure Packs because the Medtronic gloves inside may contain splits or holes that compromise sterility.

    Product
    Dr. Newman Surgical Procedure Pack, kit numbers PSS1689 PSS1689(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0223-2017·2016-10-26

    Windstone Medical Recalls Laparotomy Kits Due to Potential Sterility Compromise

    Windstone Medical Packaging is recalling 32 Laparotomy Tray kits because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Laparotomy Tray, Kit number PSS1538 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0269-2017·2016-10-26

    Windstone Medical Recalls Shoulder Arthroscopy Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 1,124 shoulder arthroscopy kits because the included Medtronic gloves may have splits or holes that compromise sterility.

    Product
    Shoulder Arthroscopy Pack, Kit number 002648-15, 002648-16, AMS2496, AMS2496(A, AMS2609, PSS2209(A, and PSS2209(B. convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0243-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because splits or holes may compromise sterility in surgical kits.

    Product
    Minor Tray AMS2685 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0207-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because splits or holes may compromise sterility in custom surgical kits.

    Product
    Head Pack, Item number PSS1934(B convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0146-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because splits or holes may compromise sterility in custom surgical kits.

    Product
    Basic Kit, Part numbers BP1110(C and CMP1109(A. convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0285-2017·2016-10-26

    Windstone Medical Recalls Dr. Fritsch Surgical Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 224 Dr. Fritsch surgical kits because the included Medtronic gloves may have splits or holes that compromise sterility.

    Product
    Dr. Fritsch Pack, Kit number AMS2696 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0175-2017·2016-10-26

    Windstone Medical Recalls Dr. Casey Pack Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 48 Dr. Casey Pack kits because the included Medtronic gloves may have splits or holes that compromise sterility.

    Product
    Dr. Casey Pack, kit number AMS4313 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0229-2017·2016-10-26

    Windstone Medical Recalls Lumbar Laminectomy Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 249 Lumbar Laminectomy Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Lumbar Laminectomy Pack, Kit number AMS2501 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0013-2017·2016-10-19

    Leiter's Compounding Recalls Ophthalmic Solution Due to Sterility Concerns

    Leiter's Compounding is recalling Cyclopentolate HCl, Tropicamide, and Phenylephrine HCl ophthalmic solution because the filters used to produce the products were recalled, creating a lack of assurance of sterility.

    Product
    Cyclopentolate HCl 1% - Tropicamide 1% - PHENYLephrine HCl 2.5% in Sterile Water for Injection (Ophthalmic Solution), in a) 1 mL Total Volume (NDC 70360-017-38) and b) 10 mL Total Volume (NDC 70360-017-39) in a 15 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose, C
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0074-2017·2016-10-19

    Banyan Medical Pyramidal Trocar Recalled for Potential Sterility Issues

    Banyan Medical is recalling 5 x 55mm Pyramidal Trocars due to a potential lack of assurance of sterility. The affected units were distributed in Indiana and Tennessee.

    Product
    Banyan Medical 5 x 55mm Regular Pyramidal Trocar and 2x Cannula. For Laproscopic Use- Sterile Single Use Only. Product Code 400-008
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0004-2017·2016-10-12

    The Apothecary Shoppe Recalls Tri-Mix 18/1/10 Due to Sterility Concerns

    The Apothecary Shoppe LLC is recalling Tri-Mix 18/1/10 vials because the medication was sterilized using a recalled filter, raising concerns about sterility assurance.

    Product
    Tri-Mix 18/1/10 (Papaverine 18mg, Phentolamine 1 mg, Prostaglandin 10 mcg/mL) packaged in 2.5 mL sterile vials, IM, Rx, The Apothecary Shoppe, Jenks, OK
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-2908-2016·2016-10-12

    Integra Drainage Accessory Kits Recalled Due to Incomplete Packaging Seal

    Integra LifeSciences Corp. is recalling specific lots of Integra Drainage Accessory Kits because a final inspection found an incomplete packaging seal, potentially compromising sterility.

    Product
    Integra Drainage Accessory Kits, REF 910122, Sterile EO, Rx only, packaged in one Tyvek pouch. Five (5) sealed Tyvek pouches are packaged in a cardboard box. Used for Intraoperative drainage of CSF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2909-2016·2016-10-12

    Integra Ventricular Catheter Accessory Kit Recalled for Incomplete Packaging Seal

    Integra LifeSciences Corp. is recalling 14 units of the Ventricular Catheter Accessory Kit due to an incomplete sterile packaging seal discovered during final inspection.

    Product
    Integra Ventricular Catheter Accessory Kit, REF 951303, Sterile EO, Rx only, packaged in a PVC tray, then secondary package in to Tyvek pouch and tertiary packaged in to Tyvek pouch. Sealed pouches are packaged in a cardboard box. F8 35cm Silicone Elastomer Ventricular Catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1543-2016·2016-10-05

    FDA Recalls Pre-Op Pledget Soln + Tetracaine Due to Sterility Concerns

    Pharmacy Plus, Inc. is recalling Pre-Op Pledget Soln + Tetracaine vials because the agency cannot ensure the product is sterile.

    Product
    Pre-Op Pledget Soln + Tetracaine, (Tropicamide (1%) 0.47ml, Phenylephrine (10%) 0.93ml, Ketorolac (0.5%) 0.47l, Ofloxacin (0.3) 0.95, Tetracaine (0.5%), 3ml vial, Rx, Vital Care Compounder, Hattiesburg, MS
    Category
    Drug
    Distribution
    1 state