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

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Minimum severity

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

Clear filters

12526–12550 of 27470

  • HighFDA (Devices)·Z-0633-2021·2020-12-23

    Maquet Cardiovascular Recalls HLS Set Advanced Due to Sterility Breach

    Maquet Cardiovascular is recalling the HLS Set Advanced because of breaches in the product's sterility barrier. The device is used with the CARDIOHELP system for cardiac and pulmonary support.

    Product
    HLS Set Advanced, Model: BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Product Code/Part Number: 70105.2794 - Product Usage: These devices are used with the CARDIOHELP system in order to provide extracorporeal circulation for cardiac support and/or pulmonary support.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0632-2021·2020-12-23

    Maquet Cardiovascular Recalls HLS Set Advanced Due to Sterility Breaches

    Maquet Cardiovascular is recalling HLS Set Advanced devices used for cardiac support due to breaches in the product's sterility barrier.

    Product
    HLS Set Advanced Model Name: BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code/Part Number: 70105.2797 - Product Usage: These devices are used with the CARDIOHELP system in order to provide extracorporeal circulation for cardiac support and/or pulmonary support.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0617-2021·2020-12-23

    Biomet Cannulated Screw System Recalled for Potential Sterile Seal Breach

    Biomet is recalling specific lots of cannulated screw systems because a breach in the sterile packaging seal could lead to loss of sterility.

    Product
    4.0/5.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm), Item numbers 110009810, 110009821, 110009825, 110009852 - Product Usage: Fracture fixationof small bones, small bone fragements and long bones.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0628-2021·2020-12-23

    Biomet Hip Prosthesis Recall for Potential Sterile Seal Breach

    Biomet is recalling specific lots of RINGLOC BIPOLAR Hip System components due to a potential breach in the sterile seal, which could lead to loss of sterility.

    Product
    RINGLOC BIPOLAR Hip System Bi Polar Locking Ring, Item number 11-165304 - Product Usage: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate, Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, Prosthesis, Hip…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0588-2021·2020-12-23

    BD PrecisionGlide Needles Recalled Due to Blood Contamination

    Becton Dickinson is recalling BD PrecisionGlide needles because blood was found on the cannulas, posing a potential infection risk if not noticed by clinicians.

    Product
    BD PrecisionGlide Needle 30G x 1/2 (0.3 mm X 13mm) REF 305106 - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampoules and parts of the body below the surface of the skin.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0636-2021·2020-12-23

    Kowa VK-2s Software Recall for Potential Patient Data Deletion

    Kowa Optimed Inc is recalling VK-2s software installed on nonmyd WX Retinal Cameras because a defect may cause the deletion of all patient information, potentially delaying treatment.

    Product
    Kowa VK-2s software Version 10.0.4.0, Product code 04987646809500 installed on Kowa nonmyd WX Retinal Cameras - Product Usage: is indicated for acquiring, displaying and storing image data from KOWA s mydriatic and non-mydriatic ophthalmic cameras.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0565-2021·2020-12-23

    Terumo Capiox FX25 Advance Oxygenator Recall for Configuration Error

    Terumo is recalling Capiox FX25 Advance Oxygenators because they may have the incorrect East or West configuration. The recall affects 5,079 units distributed in the US and abroad.

    Product
    (1) Capiox FX25 (West) Advance Oxygenator- with left port, 4-liter Reservoir, XC modified to Advance, Sterile Catalog Number: 3CX*FX25RWC (2) Capiox FX25 (East) Advance Oxygenator - FX25 with right port, 4-liter Reservoir, XC modified to Advance Catalog Number…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0541-2021·2020-12-16

    Clinical Innovations Recalls ROM Plus Collection Kits Due to Swab Defect

    Clinical Innovations is recalling ROM Plus Collection Kits because incorrect swabs may cause false test results.

    Product
    Clinical Innovations ROM Plus Collection Kit IFU: ROM Plus Rupture of Membrane Test ROM-5025, ROM-6025
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0560-2021·2020-12-16

    Medtronic Evolut PRO System Recalled for Potential Valve Leaflet Damage

    Medtronic is recalling 71,030 Evolut PRO System units worldwide due to a potential for transcatheter aortic valve leaflet damage during post-implant balloon dilatation.

    Product
    Evolut (TM) PRO System. With the following model numbers: a. EVOLUTPRO-23, Labeled as: VLV EVOLUTPRO-23 PRO COMM 29L OUS, VLV EVOLUTPRO-23 BLUE 29L COMM OUS, VLV EVOLUTPRO-23 BLUE COMM JPN, VLV EVOLUTPRO-23 BLUE 6L COMM OUS, VLV EVOLUTPRO-23 PRO COMM 29L CAN, VLV…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0557-2021·2020-12-16

    Mani Trocar Kit 23G S Recalled for Luer Connector Defects

    Mani, Inc. is recalling Trocar Kit 23G S units because Luer connector dimensions are out of specification, which may cause fluid leakage or disconnection during ophthalmic surgery.

    Product
    MANI TROCAR KIT 23G S - Product Usage: for use in injecting perfusate or aspirating out intraocular materials during ophthalmic surgery, Ref: MTK 23S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0540-2021·2020-12-16

    Avanos Medical Recalls Pediatric Feeding Tubes Due to Connector Detachment

    Avanos Medical is recalling 710 units of CORFLO NG/NI Pediatric Neonatal Feeding Tubes because the male AIV adaptor may detach from the Y-connector.

    Product
    CORFLO NG/NI Pediatric Neonatal Feeding Tube w/ Anti-IV Connector
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-0544-2021·2020-12-16

    Philips IntelliVue X2 Multi Measurement Server Speaker Failure Recall

    Philips is recalling 16 IntelliVue X2 Multi Measurement Servers because speaker failures may prevent audible alarms, potentially delaying patient treatment.

    Product
    Philips IntelliVue X2 Multi measurement Server: M3002A (865039) - Product Usage: intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates in a hospital environment and during patient transport…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0556-2021·2020-12-16

    Shimadzu MH-200S X-Ray System Recalled for Ceiling Arm Software Defect

    Shimadzu Medical Systems is recalling 22 MH-200S X-Ray systems because a software issue could cause the ceiling arm to move unexpectedly, posing a risk of collision or harm to patients and operators.

    Product
    MH-200S, system with Ceiling Suspended C-arm Support - Product Usage: intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0559-2021·2020-12-16

    Medtronic Evolut R System Recalled for Potential Valve Leaflet Damage

    Medtronic is recalling Evolut R System transcatheter aortic valves due to a potential risk of leaflet damage during post-implant balloon dilatation.

    Product
    Evolut (TM) R System. With the following model numbers: a. EVOLUTR-23, Labeled as VLV EVOLUTR-23 VT IR 6L COMM OUS, VLV EVOLUTR-23 TAV EVOLUT R CE 29L MX, VLV EVOLUTR-23 TAV CE AU 2Y MX, VLV EVOLUTR-23 TAV JPN MX, VLV EVOLUTR-23 GREY 29L COMM OUS, VLV EVOLUTR-23 TAV EVOLUT…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0542-2021·2020-12-16

    K2M Everest MI XT Tab Removal Tool Recalled for Cracking and Leakage

    K2M, Inc. is recalling 197 units of the Everest MI XT Tab Removal Tool because the threaded interface may crack, causing Loctite to leak from the handle.

    Product
    Everest MI XT Tab Removal Tool (i.e. All-In-One Tab Removal Tool)-used to break the tab off the Everest XT screw by rocking the instrument back and forth until the entire tab is fully detached from the screw head. Catalog number: 5101-90195
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0561-2021·2020-12-16

    Medtronic Evolut PRO+ System Recalled for Valve Leaflet Damage Risk

    Medtronic is recalling 19,961 Evolut PRO+ Transcatheter Aortic Valve systems due to a potential for leaflet damage during post-implant balloon dilatation.

    Product
    Evolut (TM) PRO+ System. With the following model numbers: a. EVPROPLUS-23US, Labeled as VLV EVPROPLUS-23US COMM JPN, VLV EVPROPLUS-23 COMM US; b. EVPROPLUS-26US, Labeled as VLV EVPROPLUS-26US COMM JPN, VLV EVPROPLUS-26 COMM US; c. EVPROPLUS-29US, Labeled as VLV…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0539-2021·2020-12-16

    Chromsystems Recalls MassChrom Amino Acid Analysis Plasma Control Level III

    Chromsystems Instruments & Chemicals GmbH is voluntarily recalling 342 vials of MassChrom Amino Acid Analysis Plasma Control Level III due to a Class II device defect.

    Product
    MassChrom Amino Acid Analysis Plasma Control Level III, Order No. 0473 - Product Usage: The kit is intended for amino acid metabolic screening, confirmation of a tentative diagnosis, and monitoring of treatment in individuals diagnosed with a metabolic disorder.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0558-2021·2020-12-16

    MANI Infusion Cannula 23G S Recalled for Luer Connector Defects

    Mani, Inc. is recalling MANI Infusion Cannula 23G S units because Luer connector dimensions are out of specification, which may cause fluid leakage or unintended disconnection during ophthalmic surgery.

    Product
    MANI Infusion Cannula 23G S - Product Usage: for use in injecting perfusate or aspirating out intraocular materials during ophthalmic surgery Ref: MTC 23S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0545-2021·2020-12-16

    Philips IntelliVue MP2 Patient Monitors Recalled for Speaker Failure

    Philips is recalling two IntelliVue MP2 patient monitors because speaker failures may prevent audible alarms, potentially delaying patient treatment.

    Product
    Philips IntelliVue MP2 Patient Monitors (865040) - Product Usage: intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates in a hospital environment and during patient transport inside and outside…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0552-2021·2020-12-16

    TissueTech Recalls PROKERA Slim Corneal Bandages Due to Microbial Contamination

    TissueTech, Inc. is recalling 75 units of PROKERA Slim non-sterile biologic corneal bandages due to potential exposure to microbial contamination.

    Product
    PROKERA Slim, non-sterile - Product Usage: Biologic corneal bandage.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0537-2021·2020-12-16

    Chromsystems MassChrom Amino Acid Analysis Plasma Control Level I Recalled

    Chromsystems Instruments & Chemicals GmbH is recalling MassChrom Amino Acid Analysis Plasma Control Level I kits because they do not meet stability criteria and may impact results.

    Product
    MassChrom Amino Acid Analysis Plasma Control Level I, Order No. 0471 - Product Usage: The kit is intended for amino acid metabolic screening, confirmation of a tentative diagnosis, and monitoring of treatment in individuals diagnosed with a metabolic disorder.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0547-2021·2020-12-16

    Randox Rx Series Mg Magnesium Test Kits Recalled for Performance Failure

    Randox Laboratories is recalling four kits of the Rx Series Mg Magnesium test due to reduced linearity performance.

    Product
    Randox Rx Series Mg - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catalogue Number: MG8326
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0534-2021·2020-12-16

    Shimadzu Mobile X-Ray System Recalled for Improper Handle Bolts

    Shimadzu Medical Systems is recalling 115 Mobile X-Ray Systems because the adjustable handle may have improper bolts, posing a risk of harm to individuals around the device.

    Product
    Shimadzu Mobile X-Ray System, MobileDaRt Evolution (MX8 Version), with adjustable handle option, Made in Japan - Product Usage: The device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0555-2021·2020-12-16

    Shimadzu Trinias Digital Angiography System Recalled for Ceiling Arm Software Issue

    Shimadzu is recalling 23 Trinias Digital Angiography Systems because a software defect may cause the ceiling arm to move unexpectedly, posing a risk of collision or harm to patients and operators.

    Product
    Trinias, Digital Angiography System containing a MH-200, Ceiling Suspended C-arm Support - Product Usage: intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and…
    Category
    Medical Device
    Distribution
    Distributed nationwide