The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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14876–14900 of 27471

  • HighFDA (Devices)·Z-0188-2020·2019-10-30

    Torrent Suite Dx Software Recalled for Incorrect Positive Variant Results

    Life Technologies is recalling Torrent Suite Dx software because it may incorrectly display positive results for clinical variants.

    Product
    Torrent Suite Dx Software Version 5.8 Catalog Number:A36601 and A36602 OEM Customer software: Torrent Suite Dx T430 Software v5.0 DARUI DR-SEQ 800 Software UDI:(01)10190302014090 (11)000000(10)5.8 (240)A36601
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-0171-2020·2019-10-30

    ICU Medical Recalls Plum 360 Infusion Systems Due to Software Malfunction

    ICU Medical is recalling 47,152 Plum 360 Infusion Systems because a software malfunction can cause the device to become inoperable with a blank screen when used with a MedNet Custom Drug Library.

    Product
    Plum 360 Infusion System With MedNet/ Smart Card Plug And Play Module, Model # 30010. Infusion pump.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0205-2020·2019-10-30

    Siemens Atellica IM 1600 Analyzer Software Recall for Reagent Lot Scanning Issues

    Siemens Healthcare Diagnostics is recalling Atellica IM 1600 Analyzers running software versions V1.19.0 and V1.19.2 due to issues scanning new reagent lot test definitions.

    Product
    Atellica IM 1600 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0207-2020·2019-10-30

    Candela HFC-134a Coolant Canisters Recalled for Loose Neck Bushing

    Candela Corporation is recalling HFC-134a coolant canisters because the neck bushing may become loose and separate from the canister body during use.

    Product
    Canister HFC-134a /1000g, ALUM, 15 pack Product Number: 1600-00-0219 Revision .0C Coolant canister for use with surgical laser.
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-0181-2020·2019-10-30

    Andover Healthcare Recalls Sterile Co-Flex LF2 Wound Dressings Due to Seal Defects

    Andover Healthcare Inc. is recalling 330 cases of Sterile Co-Flex LF2 3" wound dressings because of incomplete packaging seals that may compromise sterility.

    Product
    Sterile Co-Flex LF2 3" - Product Usage: Single Use secondary wound dressing or compression wrap
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0180-2020·2019-10-30

    Andover Healthcare Recalls Sterile Co-Flex NL Wound Dressings Due to Packaging Defect

    Andover Healthcare Inc. is recalling 8,500 cases of sterile Co-Flex NL 4-inch wound dressings because of incomplete packaging seals that may compromise sterility.

    Product
    Sterile Co-Flex NL 4" - Product Usage: Single Use secondary wound dressing or compression wrap
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0183-2020·2019-10-30

    Andover Healthcare Recalls Sterile Co-Flex Med Wound Dressings

    Andover Healthcare Inc. is recalling 269 cases of Sterile Co-Flex Med 3" wound dressings due to incomplete packaging seals that may compromise sterility.

    Product
    Sterile Co-Flex Med 3" - Product Usage: Single Use secondary wound dressing or compression wrap
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0167-2020·2019-10-30

    Baxter Recalls EXACTAMIX Empty EVA TPN Bags Due to Leak Risk

    Baxter Healthcare is recalling EXACTAMIX Empty EVA TPN bags because they may leak after being used for compounding sterile solutions.

    Product
    EXACTAMIX Empty EVA (Ethylene Vinyl Acetate) TPN Bag with the following product code and sizes: 1. H938737, 250mL; 2. H938738, 500mL; 3. H938739, 1000mL; 4. H938740, 2000mL; 5. H938741, 3000mL Product Usage: The EXACTAMIX Empty EVA bags are used as the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0161-2020·2019-10-30

    Luminex xTAG Respiratory Viral Panel Recalled for False Negative Results

    Luminex Molecular Diagnostics is recalling xTAG Respiratory Viral Panel kits because they may produce false negative results for Influenza A (H3) and RSV A.

    Product
    xTAG Respiratory Viral Panel (RVP): Box Label: xTAG RVP (Respiratory Viral Panel). Catalogue Number:I019C0111 in vitro diagnostic test
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0206-2020·2019-10-30

    Candela HFC-134a Coolant Canisters Recalled Due to Loose Neck Bushing

    Candela is recalling HFC-134a coolant canisters because the neck bushing may separate during use in specific legacy devices.

    Product
    Canister HFC-134a /1000g, ALUM Product Number: 1600-00-0218 Revision .0C Coolant canister for use with surgical laser.
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-0191-2020·2019-10-30

    IrriMAX Recalls Irrisept Wound Debridement System Due to Seal Defect

    IrriMAX Corporation is recalling 1,031 cases of Irrisept Wound Debridement and Cleansing Systems because a potential defect in the sterile pouch seal may result in a lack of sterility assurance.

    Product
    Irrisept Wound Debridement and Cleansing System. 12 units per case.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0190-2020·2019-10-30

    Smiths Medical Recalls GRIPPER Needles Due to Potential Occlusion

    Smiths Medical ASD Inc. is recalling GRIPPER Needles from the PORT-A-CATH II system because they may be occluded or blocked.

    Product
    GRIPPER Needles sold as part of PORT-A-CATH II SINGLE LUMEN SYSTEM. Labeled as the following item descriptions: 1. TRAY, PAC, VEN, TI, PU, 1.9MM, UL, 6FR/INTRO 1/EA; 2. TRAY, PAC, VEN LP, TI, PU, 1.9MM, UL, 6 FR/INTRO 1/EA; 3. TRAY, PAC II, VEN, 2.8MM…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0174-2020·2019-10-30

    Medline Semi-Rigid Suction Canister Lid Recall for Fragmentation Risk

    Medline Industries is recalling Semi-Rigid Suction Canisters because the lids may fragment during use, posing a risk to patients and healthcare workers.

    Product
    Semi-Rigid Suction Canister, 3000cc. Model Numbers OR530 and OR530H. For OR530, the product comes in a case with two boxes. One box includes 50 eaches of liners in a poly bag and the second box includes 50 eaches of lids in a poly bag. For OR530H, the customer receives the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0132-2020·2019-10-23

    ICU Medical Recalls Sapphire Infusion Sets Due to Potential Fluid Leakage

    ICU Medical is recalling Sapphire Epidural Infusion Sets because fluid may leak from the inline filter air vents. The recall covers 26,700 units distributed nationwide and internationally.

    Product
    Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV 123 inch. 1 unit per pouch; 50 pouches per case
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0144-2020·2019-10-23

    ICU Medical Recalls Sapphire Infusion Sets Due to Fluid Leakage Risk

    ICU Medical Inc is recalling Sapphire Microbore Infusion Sets with inline filters because they may leak fluid from air vents. The affected units were distributed nationwide and internationally.

    Product
    Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter 301 cm / 8.3 mL. 1 unit per blister; 40 blisters per case . Not distributed in the U.S.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0157-2020·2019-10-23

    Vital Scientific Selectra ProM Analyzer Recalled for Power Supply Failure

    Vital Scientific N.V. is recalling five Selectra ProM Analyzers due to power supply failures that cause instrument malfunction and prevent the production of patient results.

    Product
    Selectra ProM Analyzer, Catalog # 6003-435/UDI # 03661540600395 and Catalog # 6003-436/UDI # 03661540600401 Product Usage: :clinical chemistry system intended for use in clinical laboratories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0142-2020·2019-10-23

    ICU Medical Recalls Sapphire Infusion Sets Due to Fluid Leakage Risk

    ICU Medical is recalling Sapphire Microbore Infusion Sets with inline filters due to a potential for fluid leakage out of air vents.

    Product
    Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 0.2 Micron Filter Set Non-Vented, Microbore, 293 cm / 8.1 mL. 1 unit per pouch; 1 unit per blister; 40 blisters per case. Not distributed in the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0126-2020·2019-10-23

    ICU Medical Recalls Plum Microbore Infusion Sets Due to Leakage Risk

    ICU Medical is recalling specific Plum Microbore Infusion Sets because fluid may leak from the inline filter air vents. The recall covers 170,735 units distributed nationwide and internationally.

    Product
    Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as High-Pressure Filter PRIMARY I.V. PLUMSET Convetible Pin, 104 Inch with Orange Polyethylene-Lined*/Light Resistant Tubing, Prepierced Injection Site and OPTION-LOK. 1…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0133-2020·2019-10-23

    ICU Medical Recalls Sapphire Infusion Sets Due to Potential Fluid Leakage

    ICU Medical Inc is recalling Sapphire Microbore Infusion Sets because fluid may leak from the inline filter air vents.

    Product
    Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 0.2 Micron Filter Set Non-Vented, Microbore, PAV, CLAVE Y-Site, 122 Inch. 1 unit per pouch; 50 pouches per case
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0141-2020·2019-10-23

    ICU Medical Recalls Sapphire Infusion Sets Due to Fluid Leakage Risk

    ICU Medical is recalling Sapphire Microbore Infusion Sets with inline filters due to a potential for fluid leakage out of air vents.

    Product
    Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron Filter Set Non-Vented, Microbore 311 cm / 8.4 mL. 1 unit per pouch; 1 unit per blister; 40 blisters per case . Not distributed in the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0129-2020·2019-10-23

    ICU Medical Recalls Sapphire Infusion Sets Due to Fluid Leakage Risk

    ICU Medical is recalling Sapphire Microbore Infusion Sets because fluid may leak from the inline filter air vents.

    Product
    Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron Filter Set Microbore, 122 Inch. 1 unit per pouch; 50 pouches per case
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0140-2020·2019-10-23

    ICU Medical Recalls Sapphire Infusion Sets Due to Fluid Leakage Risk

    ICU Medical Inc is recalling Sapphire Microbore Infusion Sets with Inline Filters due to a potential for fluid leakage out of air vents.

    Product
    Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron Filter Set Non-Vented, Microbore 311 cm / 8.4 mL. 1 unit per pouch; 1 unit per blister; 40 blisters per case . Not distributed in the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0124-2020·2019-10-23

    Integra LifeSciences Recalls Cerelink ICP Monitor Due to Reading Decline

    Integra LifeSciences is recalling 189 Cerelink ICP Monitor units because they may show a progressive decline in intracranial pressure readings during use.

    Product
    Cerelink ICP Monitor, Model Number 826820; intended for use as an interface between compatible strain-gauge type pressure transducers and standard physiological pressure monitoring systems.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0128-2020·2019-10-23

    ICU Medical Recalls Plum Microbore Infusion Sets Due to Leakage Risk

    ICU Medical is recalling specific Plum Microbore Infusion Sets because fluid may leak from the inline filter air vents.

    Product
    Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set Yellow Striped Tubing, Distal Microbore Tubing, 0.2 Micron Filter, Secure Lock, 107 Inch. 1 unit per pouch; 48 pouches per case
    Category
    Medical Device
    Distribution
    Distributed nationwide