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

15676–15700 of 40112

  • 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
  • ModerateFDA (Devices)·Z-0634-2021·2020-12-23

    Roche Recalls Tina-quant C-Reactive Protein Gen.3 Reagents Due to Cross-Contamination

    Roche is recalling Tina-quant C-Reactive Protein Gen.3 reagents due to cross-contamination causing invalid calibrations and low quality control recovery.

    Product
    Tina-quant C-Reactive Protein Gen.3, Catalog number 05172373190 - Product Usage: the in vitro quantitative determination of CRP in human serum and plasma on Roche automated clinical chemistry analyzers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0637-2021·2020-12-23

    Boston Scientific Recalls EKOS Control System Units Due to RF Board Failure

    Boston Scientific is replacing 90 EKOS Control System 4.0 units in Latin America and the EU to prevent internal RF board failures at lower temperatures.

    Product
    EKOS Control System (CU) 4.0. UPN 600-40500 The EkoSonic MACH4 Endovascular (EKOS) System consists of a single use Infusion Catheter and Ultrasonic Core, and a reusable Control Unit 4.0. The device delivers the physician-specified fluids and ultrasound to the intravascular…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0635-2021·2020-12-23

    Helena Laboratories Recalls K-ACT Actalyke Clotting Test Tubes

    Helena Laboratories is recalling K-ACT Actalyke Clotting Test Tubes due to complaints of cracked or split caps.

    Product
    K-ACT Actalyke Clotting Test Tubes that are used in the: ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, and ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0615-2021·2020-12-23

    Medline Recalls RevMedX Trauma Dressings Due to Package Seal Integrity Issues

    Medline Industries is recalling RevMedX Trauma Dressings because of package seal integrity issues. The recall affects 15,780 units distributed in the US and several international countries.

    Product
    RevMedX Trauma Dressings are packaged in a Tyvek Peel pouch, 1 Trauma Dressing per Tyvec Peel Pouch, 30 Pouches per Case; Sterile - Product Usage: are intended to absorb exudates.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0612-2021·2020-12-23

    Medtronic Percept PC Neurostimulator Recall Due to Software Connection Failure

    Medtronic is recalling 12 Percept PC Implantable Neurostimulators because a software anomaly in the A620 Patient Programmer prevents connection to the device.

    Product
    Percept PC Implantable Neurostimulator (INS) - Product Usage: The Percept PC is a neurostimulation device for deep brain stimulation therapy. It is indicated for DBS treatment for Parkinson s disease, essential tremor, dystonia, obsessive-compulsive disorder, and epilepsy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0570-2021·2020-12-23

    Zimmer Biomet Recalls Polaris Spinal System Screws for Labeling Update

    Zimmer Biomet is updating instructions for Polaris and Cypher spinal screws to warn against using them with direct current stimulation due to construct failure risks.

    Product
    Polaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal System, Thoracolumbosacral pedicle screw system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0568-2021·2020-12-23

    Galt Medical Recalls Centeze Centesis Catheters Due to Tip Geometry Defect

    Galt Medical Corporation is recalling 9,920 Centeze Centesis Catheters because a manufacturing issue resulted in incorrect tip geometry, specifically a thicker wall and more obtuse tip angle.

    Product
    Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-002-06 Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-006-16
    Category
    Medical Device
    Distribution
    9 states
  • 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