The Recall Desk

Hazard

Contamination Risk recalls

993 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
993
Critical
2
Severe
112
Most recent
2026-08-12

Of the 993 contamination risk recalls we have scored against our rubric, 2 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 112 (11%) 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 contamination 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.

126–150 of 993

  • HighFDA (Devices)·Z-0333-2025·2024-11-20

    IV Bag Containers Recalled Due to Leaking During Filling

    The FDA has recalled CORMIX 250 mL empty IV bags made by The Metrix Company due to leaking during the filling process. Approximately 3,456 cases were distributed across the US and Canada.

    Product
    CORMIX 250 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64045; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0361-2025·2024-11-20

    Urine Collection Kit Specimen Containers Recalled Due to Sterility Defect

    Medline Industries is recalling over 626,000 urine collection kits due to specimen containers labeled as sterile but identified as non-sterile. The defect may result in unnecessary treatment or prolonged hospitalization.

    Product
    URINE KIT W/BD CUP, SKU DYLAB1001A; Component No. 503581
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0146-2025·2024-10-30

    Smiths Medical Tracheostomy Speaking Valve Recall for Packaging Integrity Issue

    Smiths Medical is recalling 27,971 Portex ORATOR speaking valves for tracheostomy tubes due to uncertainty in sterile packaging seal integrity. The affected units may not maintain sterile status, potentially exposing users to contamination.

    Product
    smiths medical portex, 'ORATOR' SPEAKING VALVE FOR TRACHEOSTOMY TUBE, REF 100/550/000
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0143-2025·2024-10-30

    Smiths Medical Portex Nasopharyngeal Airway recalled for sterile packaging seal integrity uncertainty

    Smiths Medical ASD Inc. is recalling 251,591 Portex Nasopharyngeal Airway units worldwide due to uncertainty in sterile packaging seal integrity, potentially compromising the sterile barrier.

    Product
    smiths medical portex, Nasopharyngeal Airway, Sizes as follows: a) AIRWAY NASOPHARYNGEAL 6.0MM, REF 100/210/060; b) AIRWAY NASOPHARYNGEAL 6.0MM, REF 100/210/060JP; c) AIRWAY NASOPHARYNGEAL 7.0MM, REF 100/210/070; d) AIRWAY NASOPHARYNGEAL 7.0MM, REF 100/210/070JP; e) AI
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0169-2025·2024-10-30

    Medline Pediatric Drape Kit Recalled Due to Potential Non-Sterile Product Risk

    Medline recalled pediatric drape kits that may become non-sterile if the pouch seal is compromised. Affected units were distributed in the US, Canada, and Panama.

    Product
    Medline PEDIATRIC DRAPE PK, REF DYNJ81297; medical procedure convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0147-2025·2024-10-30

    Smiths Medical Portex Thermovent 1200 Recalled for Sterile Packaging Seal Issues

    Smiths Medical ASD Inc. is recalling the Thermovent 1200 medical device due to uncertainty in sterile packaging seal integrity. Approximately 141,196 units distributed worldwide are affected.

    Product
    smiths medical portex, Thermovent 1200, 15mm/22mm: a) REF 100/582/000; b) REF 100/582/000JP; c) REF 100/582/000JS
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0059-2025·2024-10-23

    Monarch Inflation Device Recalled Due to Sterile Barrier Breaches

    Merit Medical Systems is recalling 1,120 Monarch Inflation Devices due to manufacturing defects causing holes and breaches in the sterile Tyvek barrier. Affected devices distributed worldwide may pose contamination risk during cardiac interventions.

    Product
    Monarch Inflation Device 30 atm/bar MAP302 Honor Hemostasis Valve Metal Insertion Tool Torque Device REF IN2330 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measur
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0060-2025·2024-10-23

    Monarch Inflation Devices Recalled for Sterile Barrier Defects

    Merit Medical Systems is recalling approximately 6,565 Monarch Inflation Devices due to manufacturing defects that compromise the sterile barrier, potentially allowing device contamination.

    Product
    Monarch Inflation Device 30 atm/bar MAP403 MBA Hemostasis Valve Metal Insertion Tool Torque Device REF IN2430 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0057-2025·2024-10-23

    Monarch Inflation Device Recalled Due to Sterile Barrier Manufacturing Defect

    Merit Medical Systems recalls 110,650 Monarch Inflation Devices due to manufacturing defects that create holes in the sterile barrier. The devices are used in cardiovascular procedures and may pose contamination risk.

    Product
    Monarch Inflation Device 30 atm/bar REF IN2130 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measure the pressure within the balloon during the procedure. It is al
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3237-2024·2024-10-02

    Medical Convenience Kit Recalled for Failed Sterilization Assurance Validation

    American Contract Systems, Inc. is recalling the Hand Pack AKHD97C medical convenience kit because an inoperable chart recorder caused humidity readings to fall outside specifications, preventing confirmation of sterilization assurance.

    Product
    Hand Pack, AKHD97C; Medical convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3231-2024·2024-10-02

    Day Surgery General Pack medical kit recalled for sterilization concern

    American Contract Systems recalled 280 units of its Day Surgery General Pack due to humidity control failures that prevent confirmation of adequate sterilization.

    Product
    Day Surgery General Pack, FHGE18T; Medical convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3243-2024·2024-10-02

    Medical device kit recalled due to inability to confirm sterilization assurance

    American Contract Systems recalled its Cysto medical convenience kit (36 units, Lot 2405033) due to a humidity monitoring failure that prevented confirmation of adequate product sterilization.

    Product
    Cysto, FTCY03L; Medical convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3299-2024·2024-10-02

    Arrow Arterial Kits Recalled Due to Open Packaging Seals

    Arrow International recalls over 14,000 arterial kits due to reports of open packaging seals. The recall affects multiple models distributed nationwide.

    Product
    Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-BW1; (2) Arrow Arterial Access Tray with 0.021" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-CK; (3) Arrow Arterial
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3244-2024·2024-10-02

    Pacemaker COPM11B Medical Kits Recalled for Sterilization Verification Issue

    American Contract Systems is recalling 3 units of the COPM11B pacemaker medical kits due to inability to confirm sterilization requirements were met. An inoperable chart recorder caused humidity readings to exceed specifications during manufacturing.

    Product
    Pacemaker, COPM11B; Medical convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3206-2024·2024-10-02

    BARD MAGNUM Biopsy Needles Recalled Due to Packaging Damage Risk

    Bard Peripheral Vascular is recalling BARD MAGNUM Disposable Core Tissue Biopsy Needles due to possible packaging damage from manufacturing that may compromise sterility.

    Product
    BARD MAGNUM Disposable Core Tissue Biopsy Needle REF: MN1410 MN 1420 MN1610 MN1616 MN1820 MN2010 The Magnum Biopsy System (instrument and needles) is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, breast, spleen, lymph nodes and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3228-2024·2024-10-02

    Endovascular AAA Pack recalled for sterilization assurance failure

    American Contract Systems recalls 360 units of Endovascular AAA Pack due to inability to confirm sterilization requirements were met. An inoperable chart recorder prevented verification that environmental conditions during sterilization met required specifications.

    Product
    Endovascular AAA Pack, ESED52B; Medical convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3240-2024·2024-10-02

    Surgical convenience kit sterilization assurance cannot be confirmed

    American Contract Systems is recalling the Essentia MAJ Laparotomy Std Pack because an equipment failure prevented confirmation of sterilization requirements for this medical convenience kit.

    Product
    Essentia MAJ Laparotomy Std Pack, ESLT53B; Medical convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0665-2024·2024-10-02

    Refresh LACRI-LUBE Eye Ointment Recalled for Potential Tube Seal Breach

    Allergen is recalling specific lots of Refresh LACRI-LUBE eye ointment (763,426 tubes) due to potential breaches in the tube seal that may compromise sterility. Consumers should verify their product lot number against the recall list.

    Product
    Refresh LACRI-LUBE, (42.5% Mineral Oil, 57.3% White Petrolatum) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube, Distributed by: Allergen, an AbbVie company, Madison, NJ 07940, UPC code: 300230312042
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3148-2024·2024-09-25

    Flexima Biliary Catheter System Kits recalled for potential sterile barrier failure

    Boston Scientific is recalling Flexima Biliary Catheter System Kit (Lot #33512376) due to potential holes in the device pouch's sterile barrier, which could compromise device sterility. No illnesses or injuries have been reported.

    Product
    Flexima Regular Kit Biliary Catheter System Kit, Material Numbers REF M001271650; bile drainage catheter with locking pigtail
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3151-2024·2024-09-25

    Boston Scientific VTC Nephrostomy Catheter Kit Recalled for Sterile Barrier Defect

    Boston Scientific is recalling VTC Regular Kit Nephrostomy Catheter System kits due to potential holes in the sterile barrier of the device pouch, which may compromise device sterility.

    Product
    VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the urinary tract.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3150-2024·2024-09-25

    Sump Catheter System Recalled for Potential Sterile Barrier Defect

    Boston Scientific is recalling the vanSonnenberg Sump Catheter System Kit because the sterile barrier pouch may have holes that could compromise device sterility. The recall affects 4 units distributed in the US, Colombia, Philippines, and Russia.

    Product
    vanSonnenberg Sump Locking Pigtail Regular Kit Sump Catheter System Kit, Material Number REF M001273090; for use as a percutaneously placed drain for intra-abdominal fluid collections.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3052-2024·2024-09-18

    Medline surgical convenience kits recalled due to defective plastic syringes

    Medline Industries is recalling multiple surgical convenience kits containing defective plastic syringes. The syringes may leak or break, posing a risk to patient health during medical procedures.

    Product
    Medline Convenience kits labeled as: 1) SPECIAL PROCEDURE PACK ARTERI , Pack Number 00-399024X ; 2) ARTHROSCOPY TRAY, Pack Number AM110A ; 3) HIP , Pack Number BM200A ; 4) SHOULDER ARTHROSCOPY, Pack Number BM230A ; 5) KNEE ARTHROSCOPY, Pack Number BM240A ; 6) PODIATRY PACK
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3097-2024·2024-09-18

    Smith & Nephew Tendon Staples Recalled for Compromised Packaging Sterility

    Smith & Nephew is recalling 2,961 units of ROTATION MEDICAL TENDON STAPLES due to improper outer foil pouch sealing that may compromise product sterility. No injuries have been reported.

    Product
    ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixation of prosthetic material to soft tissues. Product Number: 72205201
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0653-2024·2024-09-11

    Compounded Semaglutide Recalled Due to Lack of Sterility Assurance

    ProRx LLC is recalling 1,960 vials of compounded semaglutide nationwide due to lack of assurance of sterility. The multiple-dose vials may not meet sterility standards for injectable medications.

    Product
    SEMAGLUTIDE 10mg/4mL (2.5mg/mL), 4 mL Multiple Dose Vial, Rx Only, Compounded Drug, Mfd by: ProRX Exton, PA19341, NDC 84139-225-04
    Category
    Drug
    Distribution
    Distributed nationwide