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.

2201–2225 of 3438

  • SevereFDA (Drugs)·D-0186-2017·2016-12-21

    Cantrell Drug Company Recalls Calcium Chloride Bags Due to Sterility Concerns

    Cantrell Drug Company is recalling 73 bags of Calcium Chloride in 0.9% Sodium Chloride due to a lack of assurance of sterility.

    Product
    Calcium Chloride (20 mg/mL) in 0.9% Sodium Chloride 500 mL Bag, Rx Only, Single-Dose Bag Cantrell Drug Company 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-102-09
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0204-2017·2016-12-21

    Cantrell Recalls Succinylcholine Chloride Injection Due to Sterility Concerns

    Cantrell Drug Company is recalling specific lots of Succinylcholine Chloride 200 mg/10 mL injection syringes because the firm cannot ensure the products are sterile.

    Product
    Succinylcholine Chloride 200 mg/10 mL Injection Solution 10 mL (20 mg/mL) ,Single-Dose Syringe Injection Solution, For Slow IV Use Only ,Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207, NDC 52533-067-12
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0764-2017·2016-12-21

    Teleflex Visistat Skin Staplers Recalled for Sterility Deficiency

    Teleflex Medical is recalling Visistat 35W disposable skin staplers because improper packaging seals mean sterility is not assured.

    Product
    WECK Visistat 35W, Disposable Skin Stapler, Rx Only, Sterile, Teleflex Medical, NC 27709. The intended use of the Visistat stapler is to close lacerations on the outer layer of the dermis for a wide range of general, thoracic, obstetric, gynecological, orthopedic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0749-2017·2016-12-21

    Ulthera Recalls Cellfina Prep Packs Due to Non-Sterile Vacuum Tube

    Ulthera Inc is recalling Cellfina Prep Packs because they contain a non-sterile vacuum tube, while the instructions describe using a sterile tube.

    Product
    Cellfina Prep Pack, Part No. CP1
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0367-2017·2016-12-07

    Greatbatch Offset Cup Impactor Recalled for Sterility Testing Failure

    Greatbatch Medical is recalling Standard Offset Cup Impactors with POM-C handle grips because they failed sterility testing when sterilized according to the Instructions for Use.

    Product
    Greatbatch, Offset Cup Impactor with the following Parts and Catalogue #: Tl0600 ~ MMP3100CHA04 T10491 MIMP3100CHA04 T12230 M2M1P3100CHA04 T15752 ~MMP3100CHA04 T15949 ~MMP3100CHA04 T17238 MMP3100CHA04 T9954 MMP3100CHA04 T9955 MMP3100CHA04 T8468…
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0676-2017·2016-12-07

    Teleflex Recalls Arrow OnControl Bone Marrow Biopsy Systems for Sterility Concerns

    Teleflex Medical is recalling Arrow OnControl Bone Marrow Biopsy Systems due to a potential incomplete seal on the outer sterile package.

    Product
    ARROW OnControl Bone Marrow Biopsy System Comprehensive Tray, Sterile, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult and pediatric patients. The Arrow¿ OnControl Bone Marrow Biopsy System is intended for bone…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0691-2017·2016-12-07

    B. Braun Recalls Sterile IV Start Kits Due to Sterility Testing

    B. Braun Medical is recalling 15,950 Sterile IV Start Kits because non-routine sterility testing returned positive results.

    Product
    Sterile IV Start Kits 50 units/trays per case Convenience kit for IV start procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0682-2017·2016-12-07

    Sorin Group Recalls Stöckert Heater Cooler System 3T for Disinfection Review

    Sorin Group USA is recalling Stöckert Heater Cooler System 3T units to ensure strict adherence to disinfection and monitoring instructions.

    Product
    ST¿CKERT HeaterCooler System 3T; Item Number 160281, HeaterCooler 3T, 240V/60Hz; Item Number 160282, HeaterCooler 3T, 208V/60Hz; Item Number 160285, HeaterCooler 3T, 120V/ 60Hz The Heater Cooler 3T is used with a St¿ckert S3 heart lung machine and / or any other heart…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0655-2017·2016-11-30

    Hologic Recalls SURESOUND22 Uterine Sounds Due to Sterile Barrier Breach

    Hologic is recalling SURESOUND22 uterine sound multipacks because a breach in the sterile barrier compromises product sterility.

    Product
    SURESOUND22US Multipack (US Distribution) containing 2 packs of six devices. SURESOUND22 Multipack (OUS Distribution) containing 2 packs of six devices. For uterine sound
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0634-2017·2016-11-30

    Merit Medical Recalls Pressure Monitoring Kits Due to Sterile Barrier Compromise

    Merit Medical Systems is voluntarily recalling 130 MeriTrans Pressure Monitoring Kits because a compromised sterile barrier may affect product sterility.

    Product
    Pressure Monitoring Kit (MeriTrans"). Catalog Number K11-00232G
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0633-2017·2016-11-30

    Merit Medical Procedure Kits Recalled for Compromised Sterile Barrier

    Merit Medical Systems is voluntarily recalling specific Procedure Kits due to a compromised sterile barrier, which may affect the sterility of the contents.

    Product
    Waste Management Kit. Catalog Number K10-04381AP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0141-2017·2016-11-23

    Sandoz Recalls L-Cysteine Hydrochloride Injection Due to Sterility Concerns

    Sandoz Inc. is recalling L-Cysteine Hydrochloride Injection vials because an FDA inspection raised concerns that the product's sterility may be compromised.

    Product
    L-Cysteine Hydrochloride Injection, USP, 50 mg/mL, 50 mL Pharmacy Bulk Package Vials (NDC 66758-005-01), packaged in 5 x 50 mL Vials per carton(NDC 66758-005-02), Rx only, Manufactured for: Sandoz, Inc., Princeton, NJ.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0125-2017·2016-11-09

    PharMEDium Recalls Succinylcholine Chloride Vials Due to Sterility Concerns

    PharMEDium Services is recalling specific vials of Succinylcholine Chloride because a portion of the batch was compounded outside of validated process media, raising sterility concerns.

    Product
    Succinylcholine Chloride, 20 mg per mL, 200 mg per 10 mL, 10 mL vials, Rx only, PharMEDium Services, LLC, Memphis, TN, NDC 61553-0364-65.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0231-2017·2016-10-26

    Windstone Medical Recalls Major General Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 852 Major General Packs because Medtronic gloves inside may have splits or holes that compromise sterility.

    Product
    Major General Pack, Kit number 002645-11 and 002645-12 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0260-2017·2016-10-26

    Windstone Medical Packaging Recalls Peri Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 115 Peri Kits (PSS1037) because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Peri Kit, Kit number PSS1037 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0141-2017·2016-10-26

    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
    Anterior Cervical Fusion Pack, Kit part numbers: AMS2502 and AMS2502(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0274-2017·2016-10-26

    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
    Taymour GYN Pack, Kit number PSS2642 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0180-2017·2016-10-26

    Windstone Medical Packaging Recalls Endoscopy Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 304 Endoscopy Packs because disposable gloves in the kits may have splits or holes that compromise sterility.

    Product
    Endoscopy Pack, Kit number PSS1646 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0185-2017·2016-10-26

    Windstone Medical Packaging Recalls Extremity Tray Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 816 Extremity Tray kits because the included Medtronic gloves may have splits or holes that compromise sterility.

    Product
    Extremity Tray, Kit number AMS1200(B and AMS1200(C convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0233-2017·2016-10-26

    Windstone Medical Packaging Recalls Major Laparotomy Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 12 Major Laparotomy Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Major Laparotomy Pack - NS, kit number AMS4347 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0263-2017·2016-10-26

    Windstone Medical Recalls Plastic Packs with Defective Gloves

    Windstone Medical Packaging is recalling 204 plastic packs used in general surgery because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Plastic Pack , Kit number AMS1833(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0253-2017·2016-10-26

    Windstone Medical Recalls Ortho Kits Due to Potential Sterility Compromise

    Windstone Medical Packaging is recalling 145 Ortho Kits because the disposable gloves included may contain splits or holes that compromise sterility.

    Product
    Ortho Kit, Kit number PSS1039(A and PSS1039(B 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-0147-2017·2016-10-26

    Windstone Medical Recalls Basic Surgery Kits Due to Sterility Compromise

    Windstone Medical Packaging is recalling 6,381 Basic Pack surgery kits because Medtronic gloves inside may have splits or holes that compromise sterility.

    Product
    Basic Pack, Kit part numbers AMS1388(A, AMS1520, AMS1868, AMS1868(A, AMS1868(B, AMS2608, AMS2608(A, AMS2728, AMS2728(A, AMS2758, AMS2758(A, AMS2972, AMS4264, AMS4309, PSS1833, and PSS1848(A. convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide