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.

1626–1650 of 3438

  • HighFDA (Devices)·Z-1304-2019·2019-05-15

    ConMed Anchor Tissue Retrieval System Recalled for Seal Defects

    ConMed is recalling Anchor Tissue Retrieval Systems because voids or partial seals may compromise sterility. The recall covers units distributed worldwide.

    Product
    ConMed Anchor Tissue Retrieval System 10 MM, 235 ML, (5/BX) Catalog Number: TRS100SB2 The Anchor Tissue Retrieval System" by CONMED is a sterile disposable pouch used with a dedicated introducer for the encapture and removal of an organ or tissue from the body cavity during…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1306-2019·2019-05-15

    ConMed Anchor Tissue Retrieval System Recalled for Sterility Seal Defects

    ConMed is recalling Anchor Tissue Retrieval Systems due to seal defects that may compromise sterility. The recall covers 5,034 units distributed worldwide.

    Product
    ConMed Anchor Tissue Retrieval System, 15 MM, 1850 ML (3/BX) Catalog Number:TRS190SB2 The Anchor Tissue Retrieval System" by CONMED is a sterile disposable pouch used with a dedicated introducer for the encapture and removal of an organ or tissue from the body cavity during…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1255-2019·2019-05-08

    Customceutical Compounding Recalls Glutathione Injection Vials Due to Sterility Concerns

    Customceutical Compounding is recalling specific lots of compounded Glutathione 200mg/mL injection vials because the FDA could not ensure the products were sterile.

    Product
    Glutathione 200mg/mL inj. a) 10 ML and b) 12 ML MULTIDOSE VIAL MDV Compounded. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, Phoenix, AZ 85028 Ph. 480 516 0272
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1215-2019·2019-05-01

    Stryker Performance Series Sagittal Blade Recall for Sterility Breach

    Stryker is recalling 355 Performance Series Sagittal Blades due to a potential breach in sterility caused by improper packaging positioning during manufacture.

    Product
    Performance Series Sagittal Blade, Catalog Number 6125-127-100 Product Usage: The Stryker Heavy Duty Sagittal Blades are used in the cutting and shaping of bone and other bone related tissue in various orthopedic procedures. Typical procedures include, total-knee…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1136-2019·2019-04-24

    FDA Recalls Volumex Injection Due to Sterility Concerns

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

    Product
    VOLUMEX — VOLUMEX (IODINATED I-131 ALBUMIN)
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1128-2019·2019-04-24

    MSM Red Eye Eye Drops Recalled for Sterility Assurance Issues

    MSM Nutraceuticals is recalling Red Eye Eye Drops because the product lacks assurance of sterility and was not tested per USP 71.

    Product
    Red Eye, Eye Drops, Active Ingredients: OptiMSM, Glycerin USP, Hyaluronic Acid, Naphazolene Chloride, Net Wt. 15ml, 0.15 fl oz., Manufactured by: MSM Nutraceuticals, LLC , UPC 8 54582 00118 0
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1086-2019·2019-04-17

    FDA Recalls Compounded Sodium Chloride Eye Drops Due to Insanitary Conditions

    The FDA is recalling compounded sodium chloride eye drops from Professional Compounding Pharmacy in Oregon due to insanitary conditions observed during compounding.

    Product
    SODIUM CHLORIDE PRES-FREE 5% OPHTH STERILE* SOLUTION. 20ml eye drops, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1104-2019·2019-04-17

    FDA Recalls Compounded Injectable Drug Due to Insanitary Compounding Conditions

    Professional Compounding Pharmacy is recalling Papaverine-Phentolamine-PGE1 injectable due to insanitary conditions observed during compounding.

    Product
    PAPAVERINE-PHENTOLAMINE-PGE1 17.64-0.58MG-5.88MCG/ML* INJECTABLE, 9 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .
    Category
    Drug
    Distribution
    1 state
  • 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…
    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…
    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…
    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-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
  • 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-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
  • 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