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.

Filters

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All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

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All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

18651–18675 of 40124

  • HighFDA (Devices)·Z-0116-2020·2019-12-25

    GE Healthcare Recalls Aespire and Aestiva Anesthesia Systems for Cybersecurity Vulnerability

    GE Healthcare is recalling Aespire and Aestiva anesthesia systems due to a cybersecurity vulnerability that could allow malicious actors to send fraudulent flow sensor correction parameters.

    Product
    Aespire 7100, Model Numbers: 1. 1009-9000-000-009469 2. 1009-9000-000 3. 1009-9000-000-013913 4. 1009-9000-000-001366 5. 1009-9000-000-009857 6. 1009-9003-000 7. 1009-9000-000-008120 8. 1009-9000-000-009600 9. 1009-9000-000-014290 10. 1009-9000-000-010585 11.…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0696-2020·2019-12-25

    Smith & Nephew Recalls PROFIX Mallets Due to Tip Detachment Risk

    Smith & Nephew is recalling 1,371 PROFIX Mallets because the poly tip may detach during surgery, potentially releasing particles into the surgical field.

    Product
    smith&nephew PROFIX Mallet, 750 GRAMS, REF 71512452 - Product Usage: The PROFIX Mallet is a reusable surgical instrument used to tap instruments or implants during knee or hip surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0705-2020·2019-12-25

    Bio-Signal Group Recalls HydroDot Wave Prep Cups Due to B. cepacia Contamination

    Bio-Signal Group Corp. is recalling HydroDot Wave Prep single-use cups due to potential contamination with Burkholderia cepacia. The product is distributed in six US states.

    Product
    HydroDot brand: Wave Prep Single use cups, 8.5 gm (0.3 oz) 24/box-Product 1700-24 - Product Usage: An electroconductive cream for use with external electrodes to reduce the impedance of the contact between the electrode surface and the skin. The cream is not intended for use…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0115-2020·2019-12-25

    GE Healthcare Recalls Aestiva 7900 Anesthesia Systems for Cybersecurity Vulnerability

    GE Healthcare is recalling 7,168 Aestiva 7900 anesthesia systems worldwide due to a cybersecurity vulnerability that could allow malicious actors to send fraudulent flow sensor correction parameters.

    Product
    Aestiva 7900, Model Numbers: a) 1006-9300-000 b) 1006-9305-000 c) 1006-9118-000 d) 1006-9112-000 e) 1006-9113-000 f) 1006-9020-000 g) 1006-9033-000 h) 1006-9117-000 i) 1006-9119-000 j) 1006-9030-000 k) 1006-9032-000 l) 1006-9022-000 m) To be provided n)…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0117-2020·2019-12-25

    GE Healthcare Recalls Aestiva 7100 Anesthesia Systems Due to Cybersecurity Vulnerability

    GE Healthcare is recalling 473 Aestiva 7100 anesthesia systems worldwide due to a cybersecurity vulnerability that could allow malicious actors to send fraudulent flow sensor correction parameters.

    Product
    Aestiva 7100, Model Numbers: 1. 1006-9320-000 2. 1006-9321-000 3. 1006-9320-000-001101 4. 1006-9021-000 5. 1006-9012-000 6. 1006-9111-000 7. 1006-9321-000-007639 8. 1006-9321-000-000023 9. 1006-9321-000-015180 10. 1006-9320-000-010369 11. 1006-9321-000-019486 12.…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0690-2020·2019-12-25

    Teleflex Recalls Arrow EZ-IO Intraosseous Vascular Access System Needles

    Teleflex Medical is recalling 526,000 Arrow EZ-IO Intraosseous Vascular Access System kits because safety caps may dislodge, exposing needles and compromising sterility.

    Product
    Arrow EZ-IO Intraosseous Vascular Access System 45mm Needle+Stabilizer Kit, Product Code 9079P-VC-005 - Product Usage: The Arrow EZ-IO Intraosseous Vascular Access System provides intraosseous access in the proximal humerus, proximal tibia, and distal tibia of adult and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0697-2020·2019-12-25

    NxStage Low Volume Cartridge Recalled for Hemodialysis Risk

    NxStage Medical is recalling Low Volume Cartridge IFUs due to a potential health risk for low-volume patients using larger dialysate volumes.

    Product
    Low Volume Cartridge IFU (SKU CAR-125-B) used with the following devices: 1) NxStage One, Model NX1000-1; 2) NxStage VersiHD Cycler, Model Numbers: NX1000-16, and NX1000-16-A; 3) NxStage One, Model Numbers: NX1000-3 and NX1000-3-A; 4) NxStage One, Model Numbers: NX1000-10…
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0704-2020·2019-12-25

    Bio-Signal Group Recalls HydroDot Wave Prep Electroconductive Cream

    Bio-Signal Group Corp. is recalling HydroDot Wave Prep electroconductive cream due to potential contamination with Burkholderia cepacia.

    Product
    HydroDot brand: Wave Prep 4 oz. tubes-Product 1710-03. An electroconductive cream for use with external electrodes - Product Usage: An electroconductive cream for use with external electrodes to reduce the impedance of the contact between the electrode surface and the skin.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0693-2020·2019-12-25

    Medtronic Affinity Arterial Filter Recalled for Excess Plastic Flash

    Medtronic is recalling 24 units of Affinity 38um Arterial Filters due to excess plastic flash above the outlet port.

    Product
    Medtronic Affinity, 38um Arterial Filter, Catalog number REF 351
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0682-2020·2019-12-25

    Polymer Technology Systems Recalls A1CNow+ Systems Due to Software Bug

    Polymer Technology Systems is recalling A1CNow+ Systems because a software bug may display incorrect numerical values instead of expected symbols.

    Product
    A1CNow+ Systems (professional use product), Software Version Revision D, REF Numbers US: 3021, 3024; EU: 3037, 3038, 3057, 3058
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-0685-2020·2019-12-25

    ReliOn FastA1C Test Recalled for Software Bug Affecting Result Display

    Polymer Technology Systems is recalling ReliOn FastA1C Tests due to a software bug that may display incorrect numerical values instead of expected symbols.

    Product
    ReliOn FastA1C Test, Software Version Revision D, REF Number 3055
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-0718-2020·2019-12-25

    Bard Lifestream Vascular Stent Recall Due to Sheath Compatibility Issues

    Bard Peripheral Vascular is recalling 127 Lifestream stents in Australia due to potential difficulty advancing the catheter through a 6F introducer sheath.

    Product
    LIFESTREAM Balloon Expandable Vascular Covered Stent . BARD PERIPHERAL VASCULAR. 6mm X 26mm X 80 Recommended Introducer 6F (2.00mm) NP 8atm (811 kPa) Recommended Guide wire .035" (0.89mm) RBP 12 atm (1216 kPa) RX Only Lot numbers begins with CMA or CMB. Product Code…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0709-2020·2019-12-25

    Angiodynamics Recalls OARTRAC Prostate Balloon Kits Due to Accuracy Issues

    Angiodynamics, Inc. is recalling 160 OARTRAC Prostate Immobilization Endorectal Balloon Device Kits because they may produce readings outside the expected accuracy range.

    Product
    OARTRAC PROSTATE IMMOBILIZATION ENDORECTAL BALLOON DEVICE KIT, Catalog Number: ORB-60F - Product Usage: pre-calibrated PSD sensors are intended for use during cancer treatments to measure photon and electron radiation therapy as an adjunct to treatment planning permitting…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0711-2020·2019-12-25

    Angiodynamics Recalls MICRO-PSD Electron Sensors Due to Accuracy Concerns

    Angiodynamics, Inc. is recalling 36 units of MICRO-PSD Electron sensors because they may provide readings outside the expected accuracy range.

    Product
    MICRO-PSD Electron, Catalog Number: PSD-EE5N - Product Usage: pre-calibrated PSD sensors are intended for use during cancer treatments to measure photon and electron radiation therapy as an adjunct to treatment planning permitting measurement and validation of radiation dose…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0684-2020·2019-12-25

    Polymer Technology Systems Recalls Walgreens At-Home A1C Test Kits

    Polymer Technology Systems is recalling 15,118 Walgreens At-Home A1C Test Kits due to a software bug that may display incorrect numerical values for extreme results.

    Product
    Walgreens At-Home A1C Test Kit, Software Version Revision D, REF Number 3056
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-0686-2020·2019-12-25

    CVS Health At Home A1C Test Kit Recalled for Software Bug

    Polymer Technology Systems is recalling CVS Health At Home A1C Test Kits due to a software bug that may display incorrect numerical values for extreme results.

    Product
    CVS Health At Home A1C Test Kit, Software Version Revision D, REF Number 3059
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-0703-2020·2019-12-25

    Teleflex Sheridan Endobronchial Tubes Recalled for Incorrect Labeling

    Teleflex Medical is recalling Sheridan Endobronchial Tubes due to incorrectly labeled tracheal and bronchial swivel connectors.

    Product
    HUDSON RCI SHERIDAN SHERI-BRONCH Endobronchial Tube REF 5-16135 - Product Usage: The Sheridan Endobronchial Tubes are intended for use in Thoracic surgery, brochospirometry, adminitration of endobronchial anesthesia and other uses commonly requiring endobronchial intubation. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0691-2020·2019-12-25

    Integra Recalls Mislabeled Ascension Silicone PIP Joint Implants

    Integra Lifesciences is recalling nine Ascension Silicone PIP implants that were mislabeled as size 1 but contained size 0 implants.

    Product
    Ascension¿ Silicone PIP-Silicone PIP Sz 1, Model Number: SPIP5201WW - Product Usage: The Ascension Silicone PIP implant is intended for cementless replacement of the proximal interphalangeal joint in patients with advanced osteoarthritis, post-traumatic arthritis and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0713-2020·2019-12-25

    Angiodynamics Recalls Micro-PSD External Beam Photon Sensors

    Angiodynamics, Inc. is recalling 48 Micro-PSD External Beam Photon sensors due to potential accuracy issues. The devices are used to measure radiation therapy during cancer treatment.

    Product
    MICRO-PSD EXTERNAL BEAM PHOTON, Catalog Number: PSD-PE5N - Product Usage: pre-calibrated PSD sensors are intended for use during cancer treatments to measure photon and electron radiation therapy as an adjunct to treatment planning permitting measurement and validation of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0683-2020·2019-12-25

    Polymer Technology Systems Recalls A1CNow SELF CHECK Software Bug

    Polymer Technology Systems is recalling A1CNow SELF CHECK devices due to a software bug that may display incorrect numerical values instead of expected symbols.

    Product
    A1CNow SELF CHECK (European), Software Version Revision D, REF Numbers 3054, 3062
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-0692-2020·2019-12-25

    Ameditech Recalls QuickTox 5 Panel Drug Screen DipCard

    Ameditech is recalling QuickTox 5 Panel Drug Screen DipCards due to mixed products. The recall affects 3,400 units distributed in 13 US states.

    Product
    QuickTox 5 Panel Drug Screen DipCard
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-0714-2020·2019-12-25

    Alliance Tech Medical Recalls All Flow Pulmonary Function Filters

    Alliance Tech Medical is recalling All Flow Pulmonary Function Filters because patients reported a bad taste associated with the devices.

    Product
    Alliance Tech Medical, Inc. All Flow Pulmonary Function Filters, 100 filters individually packaged in a clear, sealed bag printed with the part number, 100 filters/box, for single patient use, latex free, box of 100 Reorder Numbers: 5553100 (single filter reorder no. 5553000)…
    Category
    Medical Device
    Distribution
    24 states
  • ModerateFDA (Devices)·Z-0694-2020·2019-12-25

    Tekia Recalls Mislabeled Hydrophilic Acrylic Intraocular Lenses

    Tekia, Inc. is recalling 36 intraocular lenses that may be mislabeled with the incorrect diopter power. No U.S. distribution occurred.

    Product
    TEKIA Model 872 Single Piece Hydrophilic Acrylic Intraocular Lenses, Diopter 15.0, Sterile. The firm name on the label is TEKIA, INC., Irvine, CA.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0708-2020·2019-12-25

    Rhondium OVC3 One Visit Crown Recalled for Incorrect Expiration Date

    Rhondium Limited is recalling six OVC3 One Visit Crown devices because they were mislabeled with an incorrect expiration date.

    Product
    Rhondium OVC3 One Visit Crown, Model FDI 24/25L USA 12/13L A2 HT, Nonsterile, Rx. The firm name on the label is Rhondium Ltd., Katikati, New Zealand.
    Category
    Medical Device
    Distribution
    4 states