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.

1626–1650 of 3429

  • HighFDA (Devices)·Z-1046-2019·2019-04-03

    Avitus Bone Harvester Recalled for Potential Sterility Compromise

    Avitus Orthopaedics is recalling 508 Bone Harvester units because a breach in the sterile barrier pouch may compromise the device's sterility.

    Product
    Avitus¿ Bone Harvester w/ Filter Insert - 8mm intended to harvest cancellous bone and bone marrow Catalog Number: BH-110 The Avitus¿ Bone Harvester is intended to harvest cancellous bone and bone marrow
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1041-2019·2019-04-03

    Kendall SCD Express Sterile Sleeves Recalled for Sterility Failure

    COVIDIEN LLC is recalling Kendall SCD Express Sterile Sleeves (Thigh Length) because they were distributed without undergoing sterilization.

    Product
    Kendall SCD Express Sterile Sleeves (Thigh Length), Model Number 9736
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Drugs)·D-1025-2019·2019-03-27

    Advanced Pharma Recalls Glycopyrrolate Injectable Syringes Due to Sterility Concerns

    Advanced Pharma Inc. is recalling 140 syringes of Glycopyrrolate 0.6 mg/3 mL Injectable Solution because the company cannot ensure the product is sterile.

    Product
    Glycopyrrolate 0.6 mg/3 mL (0.2 mg per mL) Injectable Solution, 3 mL Sterile single use syringe, For IV or IM use, NDC: 42852-828-22 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1008-2019·2019-03-27

    FDA Recalls Volumex Iodinated I-131 Albumin Due to Sterility Concerns

    Iso-Tex Diagnostics is recalling 54 syringes of Volumex (Iodinated I-131 Albumin) because environmental monitoring results exceeded limits, meaning sterility cannot be assured.

    Product
    VOLUMEX — VOLUMEX (IODINATED I-131 ALBUMIN)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-1036-2019·2019-03-27

    ConvaTec Recalls Feeding Tubes Due to Potential Sterile Barrier Breach

    ConvaTec is recalling specific lots of Feeding Tube Metric devices because an internal assessment found a potential breach in the sterile barrier.

    Product
    Feeding Tube Metric, disposable, sterile, 100 eaches per sales unit. Labeled as: xray CH05/40CM and xray CH08/40CM Product Usage: Duodenal and Stomach Gastroenterology Tubes are sterile disposable devices which may be inserted through the nose or mouth via the esophagus into
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1037-2019·2019-03-27

    ConvaTec Recalls Nelaton Urinary Catheters Due to Sterile Barrier Breach Risk

    ConvaTec is recalling Nelaton Urinary Catheters because an internal assessment found a potential breach in the sterile barrier, which could compromise the device's sterility.

    Product
    Nelaton Urinary Catheter, disposable, sterile, 100 eaches per sales unit. Labeled as: CH16/40CM and CH14/40CM Product Usage: Urinary Catheters are sterile disposable devices intended to provide an intermittent pathway for drainage of fluids from the bladder. They are intended
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1035-2019·2019-03-27

    ConvaTec Recalls Forceps Blue Due to Potential Sterile Barrier Breach

    ConvaTec, Inc. is recalling Forceps Blue, disposable sterile forceps, because an internal assessment confirmed the potential for a breach in the sterile barrier.

    Product
    Forceps Blue, disposable, sterile, 100 eaches per sales unit. Product Usage: Forceps are sterile disposable devices intended for use during clinical procedures to grasp, manipulate, maneuver or assist with the removal of debris, particulates or wound tissue. Typically, forcep
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0964-2019·2019-03-06

    FDA Recalls Surgical Convenience Kits Due to Potential Sterilization Failure

    American Contract Systems, Inc. is recalling 51,152 surgical convenience kits distributed in Florida because they may not have reached complete sterilization.

    Product
    Bag size #4 Custom Convenience Kits Usage: Surgical convenience kits labeled as the following: a. Tray Name: PACK BASIC SET UP LH - 2035102, Tray Number: LSRBASICPACD; b. Tray Name: PACK ANGIOGRAM CFH - 2071297, Tray Number: LSRCFHANGD; c. Tray Name: PACK B
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0508-2019·2019-02-27

    US Compounding Recalls Ephedrine Sulfate Syringes Due to Sterility Concerns

    US Compounding Inc is recalling 1,686 syringes of Ephedrine Sulfate 50 mg/10 mL because the company cannot ensure the product is sterile.

    Product
    Ephedrine Sulfate, 50 mg/10 mL, 10 mL Single Use Syringe, Rx only, US Compounding Pharmacy 1270 Don's Lane Conway, AR 800-718-3588, Barcode: 62295308407
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0471-2019·2019-02-20

    Promise Pharmacy Recalls Zinc Sulfate Injection Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling specific lots of Zinc Sulfate injection due to a lack of sterility assurance. The product was distributed nationwide.

    Product
    Zinc Sulfate, 5mg/mL injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0817-2019·2019-02-13

    Bone Marrow Biopsy Needle Recall Due to Sterile Seal Manufacturing Issue

    Angiotech is recalling 500 units of Double Diamond J Type Bone Marrow Needles due to a manufacturing defect in the sterile seal on blister trays.

    Product
    Double Diamond J Type Bone Marrow Needle & Marrow Extraction Cannula 11ga x 10cm 14MTWX x 12.5 cm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0816-2019·2019-02-13

    Angiotech Recalls Bone Marrow Needles Due to Sterile Seal Manufacturing Issue

    Angiotech is recalling 180 units of J Type Bone Marrow Needles due to a manufacturing issue affecting the sterile seal on blister trays.

    Product
    J Type Bone Marrow Needle 13ga x 6cm - Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0814-2019·2019-02-13

    Angiotech Recalls Bone Marrow Biopsy Needles Due to Sterile Seal Defect

    Angiotech is recalling specific lots of bone marrow biopsy needles because a manufacturing issue may have compromised the sterile seal on the blister trays.

    Product
    "J" Type Bone Marrow Needle 11ga x 10 cm - Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0820-2019·2019-02-13

    Bone Marrow Biopsy Needle Recall Due to Sterile Seal Manufacturing Issue

    Angiotech is recalling 504 bone marrow biopsy needles due to a manufacturing issue affecting the sterile seal on blister trays.

    Product
    Aguja de Aspiration con Profundidad Ajustable Tipo I 15ga x 5 cm - Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0815-2019·2019-02-13

    Angiotech Recalls Bone Marrow Biopsy Needles Due to Sterile Seal Defect

    Angiotech is recalling 1,260 bone marrow biopsy needles due to a manufacturing issue affecting the sterile seal on blister trays.

    Product
    J Type Bone Marrow Needle 13ga x 10 cm- Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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¿ an
    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-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-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-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