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 deaths or serious injuries are reported, 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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All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

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

Clear filters

11751–11775 of 13816

  • HighFDA (Devices)·Z-1137-2022·2022-06-01

    Progenamatrix Human Keratin Matrix Recalled for Inadequate Pouch Seal

    ProgenaCare is recalling progenamatrix Human Keratin Matrix due to inadequate inner pouch seals that may compromise sterility. The recall affects 547 packages distributed in Alabama, Georgia, Florida, Tennessee, and Texas.

    Product
    progenamatrix Human Keratin Matrix, sterile, Rx, with the following model numbers: (1) PM2012, 12 x 2 cm; (2) PM3002, 2 x 2 cm; (3) PM3004, 4 x 4 cm; PM3006, 6 x 6 cm; and PM3010, 10 x 10 cm.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1126-2022·2022-06-01

    Gibeck Humid-Vent Breathing Filters Recalled for Torn Corrugated Tubes

    Teleflex Medical is recalling Gibeck brand respiratory filters due to reports of torn corrugated breathing tubes. No injuries have been reported.

    Product
    (1) Gibeck Humid-Vent 2S Flex DC, Product #17731, sterile; (2) Gibeck Humid-Vent 2S Flex DC, Product #17732, non-sterile; (3) Gibeck Humid-Vent Filter Compact S with Smooth-Flo/Swivel, Product #19061, sterile; (4) Gibeck Humid-Vent Filter Compact S with Smooth-Flo/Swivel, Prod
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1132-2022·2022-06-01

    Surgical Suture Kit Recalled for Uncertain Sterile Barrier Integrity

    Stradis Healthcare is recalling 7,340 units of Surgical Suture Kit due to uncertainty about sterilization methods that ensure sterile barrier integrity. Affected lots should not be used.

    Product
    Surgical Suture Kit
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1134-2022·2022-06-01

    SUR-FIT Natura Durahesive Wafer Recalled for Skin Barrier Delamination

    ConvaTec is recalling 600 market units of SUR-FIT Natura S4S Durahesive Wafer due to skin barrier delamination. The wafer's layers or tape borders may fail to maintain proper seal, potentially affecting skin protection.

    Product
    SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10 individual wafers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1131-2022·2022-06-01

    Medtronic Cardioblate Gemini-s Surgical Ablation System Recalled for Fractured Jaw Tips

    Medtronic is recalling 1,236 units of the Cardioblate Gemini-s surgical ablation system due to an increase in complaints about fractured jaw tips. The device is used in cardiac ablation procedures worldwide.

    Product
    Cardioblate" Gemini"-s Irrigated RF Surgical Ablation System; The device is placed in a plastic tray with a snap on plastic lid, the tray is placed in protective wrap, then into a sterile pouch, 1 device per carton, 1 carton per box.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1135-2022·2022-06-01

    Medical beds with motorized wheels face uncontrolled motion risk

    Umano Medical recalls 228 adjustable hospital beds due to potential electrical system failure that could cause uncontrolled movement of the motorized wheel system.

    Product
    AC-powered adjustable medical beds with built-in electric DC actuators and controls.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1121-2022·2022-06-01

    Unclearred VerifyNow P2Y12 Platelet Test Variant Distributed to Healthcare Providers

    Accriva Diagnostics distributed an unclearred variant of the VerifyNow P2Y12 platelet test that displays different results than the FDA-cleared device. A correction formula has been provided to healthcare providers.

    Product
    The VerifyNow P2Y12 Test is designed to measure platelet P2Y12 receptor blockade. Substances known to specifically block the P2Y12 receptor include ticagrelor and the thienopyridine class of drugs, including clopidogrel and prasugrel.1-8 The test is based upon the ability of acti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1124-2022·2022-06-01

    HydroMARK Breast Biopsy Marker Label Mismatch on Patient Documentation

    Devicor Medical Products is recalling 90 HydroMARK Breast Biopsy Markers due to mismatched patient labels that incorrectly identify the product model. The small patient label identifies the device as model 4010-05-08-T3, while the correct model is 4010-05-08-T4.

    Product
    HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1136-2022·2022-06-01

    Medical beds recalled for potential motorized wheel system failure

    Umano Medical is recalling 355 adjustable medical beds because an electrical system component failure could cause the motorized wheel system to move uncontrollably, risking patient injury.

    Product
    AC-powered adjustable medical beds with built-in electric DC actuators and controls.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1120-2022·2022-06-01

    Protekt Sharps Safety Knives with Incorrect Size Label

    International Science & Technology is recalling Protekt Sharps Safety Knives (PG 44620MU) because some handles are labeled with an incorrect blade size of 2.5mm when the actual size is 2.2mm.

    Product
    Outer Packaging Label: Protekt Sharps Safety Knives - REF: PG 44620MU, Sterile R, Multi-Use 2.2mm Double Bevel Slit, Angled 6 units, Individual Packaging Label: ProTekt Sharps Safety Knives - REF: PG 44620MU,2.2mm double Bevel Slit, Sterile R, Angled 1 unit, Handle La
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1127-2022·2022-06-01

    Teleflex Breathing Tubes Recalled Due to Reports of Tearing

    Teleflex Medical Inc is recalling four models of breathing tubes following reports of torn corrugated tubes. Approximately 290,809 units are affected worldwide.

    Product
    (1) Teleflex Flex tube, Product #20011, sterile; (2) Teleflex Smooth-Flo Flex with Double Swivel, Product #22511, sterile; (3) Teleflex Smooth-Flo Flex with Double Swivel, Product #22512, non-sterile; (4) Teleflex Smooth-Flo Flex, Product #22552, non-sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1129-2022·2022-06-01

    Percept PC BrainSense Implantable Neurostimulator Recalled for Communication Failure

    Medtronic has recalled the Percept PC BrainSense Implantable Neurostimulator Model B35200 due to communication failures with programmer systems. The device cannot reliably communicate with clinical or patient programmer systems.

    Product
    Percept PC BrainSense Implantable Neurostimulator (INS) Model B35200
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1133-2022·2022-06-01

    INTERTAN 1.5 nail orthopedic implants recalled due to reversed left-right labeling

    Smith & Nephew is recalling INTERTAN 1.5 nails because right nails were marked and labeled as left nails, and vice versa. This mislabeling could lead to incorrect surgical placement.

    Product
    INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Left INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Right
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1128-2022·2022-06-01

    Medtronic Percept BrainSense Neurostimulator Cannot Communicate with Programmer Systems

    Medtronic is recalling 14,164 Percept BrainSense Implantable Neurostimulators (Model B35200) worldwide because the devices cannot communicate with clinical or patient programmer systems, preventing proper device monitoring and adjustment.

    Product
    Percept BrainSense Implantable Neurostimulator (INS), Model B35200
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1130-2022·2022-06-01

    Invacare TDX SP2 Power Wheelchairs May Lose Power Due to Battery Harness Disconnection

    Invacare TDX SP2 power wheelchairs may experience battery harness disconnection during shipment or use, resulting in loss of power. Approximately 133 affected devices have been distributed in the U.S. and Canada.

    Product
    Invacare TDX SP2, Model Nos. TDXSP2 TDXSP2-MCG TDXSP2V
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1123-2022·2022-06-01

    Vanta INS Neurostimulator May Fail to Communicate with Programmer Systems

    Medtronic has recalled certain Vanta INS Implantable Neurostimulator devices that may fail to communicate with clinical or patient programmer systems, preventing proper monitoring and therapy adjustments.

    Product
    Vanta INS Implantable Neurostimulator. Medtronic Model 977006 Vanta with AdaptiveStim Technology Neurostimulator with Surescan MRI technology, part of a neurostimulator system for pain therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1140-2022·2022-06-01

    Medical Calcium Reagent Shipped Without Required Refrigeration; QC Failure Risk

    A medical lab reagent (ABX Pentra Calcium AS CP) was shipped at room temperature instead of refrigerated, causing probable quality control failure. Affected patients may experience diagnostic delays and require repeat testing.

    Product
    ABX Pentra Calcium AS CP, Reagent 90 mL, REF A11A01954
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1118-2022·2022-06-01

    Steris Recalls Ultra Pure Non-Woven Sponges for Unapproved Distribution

    Steris Corporation is recalling 103 cases of Ultra Pure Non-Woven Sponges (Lot 202108) distributed nationwide because the product was released without FDA approval. Customers should discontinue use and contact the manufacturer.

    Product
    Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 5,000 per case 25 sleeves of 200 2 in x 2 in / 5.1 cm x 5.1 cm Model Number: ENC100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1119-2022·2022-06-01

    Steris Non-Woven Sponges recalled; product not approved for US distribution

    Steris Corporation is recalling 152 cases of Ultra Pure Non-Woven Sponges because the product was not approved for release for US distribution.

    Product
    Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 2,000 per case 10 sleeves of 200 4 in x 4 in / 10.2 cm x 10.2 cm Model Number: ENC4100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1125-2022·2022-06-01

    Medical device labeling error: KWIK-STIK® plus Clostridium perfringens

    Microbiologics Inc recalled 8 units of KWIK-STIK® plus Clostridium perfringens due to a labeling error. The affected lot (801-44-4) was distributed to laboratories in the United States and internationally.

    Product
    KWIK-STIK" plus: Clostridium perfringens
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1032-2022·2022-05-25

    Avanos Cortrak 2 Enteral Access System Anonymous Account Mode Discontinued

    Avanos Medical is modifying labeling for the Cortrak 2 Enteral Access System and discontinuing the Anonymous Account Mode feature. Users must confirm tube placement per institutional protocol.

    Product
    Avanos Cortrak 2 Enteral Access System (EAS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1077-2022·2022-05-25

    FDA Recalls iCast Covered Stent System Due to Device Separation During Delivery

    Atrium Medical is recalling the iCast Covered Stent System because the balloon or catheter hub may separate from the delivery catheter during use, potentially causing blood clots, vessel blockages, or organ damage.

    Product
    iCast Covered Stent System Product Code/Part Number: 85400 85401 85402 85403 85404 85405 85406 85407 85408 85409 85410 85411 85412 85413 85414 85415 85416 85417 85418 85419 85420 85424 85440 85441 85442 85443 85444 85445 85450 85451 85452 85453
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1076-2022·2022-05-25

    Atrium Advanta V12 Covered Stent System Recalled for Delivery Catheter Separation

    Atrium Medical is recalling the Advanta V12 Covered Stent System worldwide for potential separation of the balloon or catheter hub during withdrawal, which may cause procedural delays and serious complications including embolism and organ infarction.

    Product
    Atrium Advanta V12 Covered Stent System (OUS only). Product Code/Part Number: 85320 85321 85322 85323 85324 85325 85326 85327 85328 85329 85330 85331 85332 85333 85334 85335 85336 85337 85338 85339 85340 85341 85342 85343 85344 85345 85350 85351 85352 85353 85354 85355 85360
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1095-2022·2022-05-25

    Dragonfly OpStar Imaging Catheter Recall Due to Proximal Marker Separation Risk

    Abbott Vascular recalls 14,544 Dragonfly OpStar Imaging Catheters due to potential separation of the proximal marker. The affected devices were distributed throughout the US and internationally.

    Product
    Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EO
    Category
    Medical Device
    Distribution
    44 states