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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9926–9950 of 27441

  • 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-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-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-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…
    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-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…
    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
  • 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
  • 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
  • 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
  • HighFDA (Devices)·Z-1092-2022·2022-05-25

    Verigene Processor heating system may produce false negative results

    Luminex Corporation is recalling 24 Verigene Processor SP units because the heater may operate outside established temperature limits, potentially producing false negative diagnostic results.

    Product
    Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-1086-2022·2022-05-25

    Medical analyzer instruments recalled for incorrect power connector rating

    Beckman Coulter is recalling DxM 1096 MicroScan WalkAway Instruments because some units may have an incorrect AC power entry connector rated at 1 ampere instead of 10 amperes, posing a potential electrical safety risk.

    Product
    DxM 1096 MicroScan WalkAway Instrument REF B1018-496
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1079-2022·2022-05-25

    FDA Updates EXALT Duodenoscope Instructions for Known Perforation Risk

    Boston Scientific's EXALT Model D duodenoscope is subject to updated use instructions addressing a known risk of perforation. The FDA requires updated guidance on insertion and removal procedures.

    Product
    EXALT Model D Single- Use Duodenoscope (Box 1) UPN: M00542420 Intended Use: sterile, single-use, flexible video duodenoscope intended for use with the EXALT" Controller to examine duodenum and perform various procedures within the duodenum including endoscopy and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1106-2022·2022-05-25

    HeartWare Ventricular Assist Device recalled for translation errors

    Heartware, Inc. is recalling the HeartWare Ventricular Assist Device (HVAD) in Finland and Turkey due to translation errors in device displays and supporting documentation that could impair proper device operation.

    Product
    HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1087-2022·2022-05-25

    MicroScan WalkAway-40 Medical Instruments Recalled for Incorrect Power Connector Rating

    Three MicroScan WalkAway-40 medical instruments were recalled because they have an AC power connector rated at 1 ampere instead of the correct 10 ampere rating. This mismatch poses a potential electrical and fire hazard.

    Product
    MicroScan WalkAway-40 plus Reconditioned Instrument REF B1018-340R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1099-2022·2022-05-25

    Smith & Nephew knee implants recalled for labeling error

    Smith & Nephew is recalling knee implants shipped in incorrect packaging—a JOURNEY II femoral implant was boxed as a LEGION NARROW PS implant. The labeling error could result in the wrong implant being used during surgery.

    Product
    LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1117-2022·2022-05-25

    Portable Oxygen Concentrator Recalled for Lack of FDA Clearance

    Caire, Inc. is recalling two CAIRE FreeStyle Comfort portable oxygen concentrators because they were not cleared by the FDA for U.S. distribution. The affected devices were distributed to Puerto Rico.

    Product
    CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1093-2022·2022-05-25

    NaviCare Nurse Call System: Firmware Memory Leak in Supplier Component

    Baxter Healthcare is recalling 11,028 NaviCare Nurse Call Systems distributed in North Carolina and Virginia due to a firmware memory leak in a supplier-manufactured component.

    Product
    NaviCare Nurse Call System provides a comprehensive communication and information system that places patient calls, staff calls, and emergency calls.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1100-2022·2022-05-25

    Affinity Dental Impression Material Recalled for Wrong Material

    Clinician's Choice Dental Products is recalling Affinity Hydroactive Impression Material Heavy Body Regular Set because Template Ultra Quick matrix Material was packaged instead of the indicated Heavy Body viscosity. The recall affects 46 units distributed in South Carolina.

    Product
    Affinity Hydroactive Impression Material Heavy Body Regular Set 12PK- A vinyl poly siloxane material used to create, via impression, a reproduction of tooth and gum structure. Product ID: 013912
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1084-2022·2022-05-25

    Medical Device Maker Recalls Laboratory Instrument With Incorrect Power Connector Rating

    Beckman Coulter Inc. is recalling 7 MicroScan WalkAway-96 plus instruments due to an AC power connector rated for 1 ampere instead of the required 10 amperes. The underated connector could fail or overheat during normal operation.

    Product
    MicroScan WalkAway-96 plus Instrument REF B1018-284
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1107-2022·2022-05-25

    HeartWare HVAD Ventricular Assist Device Recalled for Translation Errors

    HeartWare is recalling 645 units of HVAD Ventricular Assist Device documentation due to translation errors in Finnish and Turkish. The errors affect controller displays, patient manuals, and emergency responder guides.

    Product
    HeartWare Ventricular Assist Device (HVAD) System, individual pamphlets: HVAD¿ System Emergency Responder Guide (FI-Finnish) HVAD¿ System Emergency Responder Guide (FI-Finnish) HVAD¿ System Emergency Responder Guide (FI-Finnish) HVAD¿ System Emergency Responder Guide…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1089-2022·2022-05-25

    Acetaminophen tablets in first aid kits recalled for contamination risk

    Total Resources International first aid kits containing acetaminophen tablets are being recalled due to potential cross-contamination from manufacturing equipment damage at the tablet supplier.

    Product
    Total Resources International First Aid Kits, Item Numbers: 10HBC01087, 10HBC01092A3PK, 10HBC01112, 10HBC01113, 10HBC01329GLRV1, 10OUT02086GLRV2, 16BLU01495, 20HBC01015CCREV3, 20HBC01084GLOWCC. Kit contents include ULTRAtab Laboratories Coated APAP 325 mg (Acetaminophen 325…
    Category
    Drug
    Distribution
    30 states