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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11101–11125 of 27470

  • HighFDA (Devices)·Z-2324-2021·2021-08-25

    CIRCUL8 LUXE DVT Prevention Device Marketed Without FDA Clearance

    The CIRCUL8 LUXE DVT Prevention Device is being recalled because it was marketed without FDA clearance. The device is intended to aid in the prevention of deep vein thrombosis.

    Product
    CIRCUL8 LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF: 08-0020, Rx Prescription Only, Not Sterile IP22, Latex Free,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2304-2021·2021-08-25

    I.V. Catheter Recall Due to Possible Sterilization Failure

    Delta Med recalls NEO DELTA SELFSAFE PUR T I.V. catheters distributed in Florida and Minnesota due to sterilization problems. Non-sterile catheters pose infection risks.

    Product
    NEO DELTA SELFSAFE PUR T, I.V. Catheter:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2291-2021·2021-08-25

    Tornier Aequalis Pyrocarbon shoulder implants recalled for potential graphite exposure

    Tornier recalls Aequalis Pyrocarbon shoulder implants (6,631 units) due to potential patient exposure to graphite substrate material. The units were distributed across multiple U.S. states.

    Product
    The Aequalis Pyrocarbon Humeral Heads. Shoulder implant component. Sold OUS only: a) Catalog # DWH039 - Diameter 39 mm Height 14 mm Eccentric LOW (1.5) Material PyC/CoCr, b) Catalog # DWH041 - Diameter 41 m m Height 15 mm Eccentric LOW (1.5) Material PyC/CoCr, c) Catalog
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-2300-2021·2021-08-25

    IV Catheters Recalled Due to Possible Missing Sterility

    Delta Med SpA is recalling NEO DELTA Self Safe 1 IV catheters due to possible missing sterility. The recall affects 5,000 units distributed in Florida and Minnesota.

    Product
    NEO DELTA Self Safe 1, I.V. Catheter with PUR REF 3708122, Lot 00A1160627 5000 units
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2321-2021·2021-08-25

    RUSCH Endotracheal Tubes Recalled for Potential Cuff Inflation Malfunction

    Teleflex Medical Europe is recalling RUSCH endotracheal tubes because the cuff can inflate without the pilot balloon showing proper inflation. This defect could prevent clinicians from verifying correct cuff function.

    Product
    RUSCH Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF numbers: a) 112080050 b) 112080055 c) 112080060 d) 112080065 e) 112080070 f) 112080075 g) 112080080 h) 112080085 i) 112080090 j) 112080095 k) 112080100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2312-2021·2021-08-25

    NEO-KATH Epidural Catheter Set recalled for potential stylet protrusion

    Epimed International recalls NEO-KATH Epidural Catheter Set (Lot 16308275, 16308382) due to potential stylet protrusion from the catheter distal end, which poses injury risk during epidural procedures.

    Product
    NEO-KATH Epidural Catheter Set, REF 200-2430, Sterile
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-2294-2021·2021-08-25

    Soltive Laser Systems recalled for thermal burn injury risk during stone treatment

    Olympus is recalling Soltive laser systems used in urological surgery because exceeding recommended power settings can cause thermal burns to tissue during kidney stone treatment.

    Product
    Soltive Premium Super Pulsed Laser System (TFL-PLS) & Pro Super Pulsed Laser System (TFL-SLS). Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in urology, lithotripsy, gastroenterologica
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2325-2021·2021-08-25

    Evexia Luxe DVT Prevention Device Recalled for Marketing Without FDA Clearance

    Ortho8, Inc. is recalling the Evexia Luxe DVT Prevention Device because it was marketed without required FDA clearance. The device is intended to prevent deep vein thrombosis.

    Product
    EVEXIA LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF(s): EVE-11/EVE-X11, Rx Only, Not Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2292-2021·2021-08-25

    Gore Propaten Vascular Graft Pediatric Shunt Dimension Labeling Error Recall

    W L Gore & Associates is recalling Gore Propaten Vascular Grafts for pediatric shunts due to incorrect diameter labeling: grafts with 6mm inner diameter are labeled 5mm, and those with 5mm diameter are labeled 6mm.

    Product
    Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 5 mm, Length 10 cm, Rx Only, Sterile EO, for the following Reference numbers: HPT050010 UDI: (01)00733132606320 HPT050010A UDI: (01)00733132606337
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2328-2021·2021-08-25

    TheraSphere Administration Set may leak or loosen at catheter connection

    Boston Scientific is recalling TheraSphere Administration Sets due to potential leaks and loosening at the patient catheter connection. Approximately 4,200 sets were distributed worldwide.

    Product
    TheraSphere Administration Set, REF OTT-SPE-FP-001 (990264.SPE)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2316-2021·2021-08-25

    CT system software error recommends excessive contrast volume

    A software defect in Philips CT imaging systems causes incorrect contrast volume calculations when patient weight units are set to pounds, resulting in increased contrast dosing recommendations. Three units with specific serial numbers are affected.

    Product
    728327 Ingenuity CT Upgrades-Computed Tomography X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2293-2021·2021-08-25

    Gore Propaten Vascular Graft Pediatric Shunt Diameter Labeling Error

    W L Gore is recalling certain Gore Propaten Vascular Grafts for pediatric shunts due to incorrect diameter labeling. Grafts labeled as 5 mm may actually be 6 mm and vice versa.

    Product
    Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 6 mm, Length 15 cm, Rx Only, Sterile EO, for the following Reference numbers: HPT060015 UDI: (01)00733132606368 HPT060015A UDI: (01)00733132606375
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2326-2021·2021-08-25

    Surgical stapler mislabeled with incorrect device size

    Ethicon is recalling ECHELON FLEX Powered Plus Staplers because the product packaging is mislabeled; packages labeled as 60mm contain 45mm devices, which could affect surgical outcomes if the incorrect size is used.

    Product
    ECHELON FLEX Powered Plus Stapler-intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. Product Code: PSEE60A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2287-2021·2021-08-25

    Trilogy Evo Ventilator Software Defect May Cause Pressure Increase

    Philips Respironics recalls Trilogy Evo ventilators due to software issues that may increase pressure delivery to patients. The defect affects multiple product variants worldwide.

    Product
    Trilogy Evo, Product numbers BL2110X15B, CA2110X12B, DE2110X13B, DS2110X11B, EE2110X15B, ES2110X15B, EU2110X15B, EU2110X19, FR2110X14B, GB2110X15B, IA2110X15B, IN2110X15B, IN2110X19, IT2110X21B, KR2110X15B, LA2110X15B, LD2110X23B, ND2110X15B, RDE2110X13B, UDS2110X11B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2310-2021·2021-08-25

    OPTI SARS-CoV-2 RT-PCR Test Kits Recalled for False Positive Results

    OPTI Medical Systems is recalling COVID-19 test kits due to a precipitation issue that may cause false positive results in 5-10% of affected vials. No illnesses have been reported.

    Product
    OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2315-2021·2021-08-25

    CT5000 X-ray System Contrast Dose Calculation Error Under Pounds Setting

    Philips CT5000 X-ray systems may incorrectly calculate contrast volume doses when patient weight units are set to pounds. The software error could recommend higher-than-intended contrast volumes.

    Product
    Model 728321/728323 CT5000 Ingenuity Plus/Pro/Premium-Computed Tomography X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2296-2021·2021-08-25

    FDA Recalls DELTAVEN Y Safety IV Catheters Due to Sterilization Issues

    Delta Med SpA is recalling DELTAVEN Y DNL Safety IV Catheters with closed system due to sterilization problems. The recalled units may lack proper sterility and pose a risk to patients.

    Product
    DELTAVEN Y DNL Safety I.V. Catheter in Pur with closed system: a) REF 3832572 b) REF 3842572 c) REF 3821572 d) REF 3833572 e) REF 3831572 f) REF 3810572 g) REF 3852572
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2313-2021·2021-08-25

    NEO-KATH Caudal Catheter Set Recalled Due to Stylet Protrusion Risk

    Epimed International is recalling the NEO-KATH Caudal Set (REF 201-2430) because the stylet may protrude from the catheter's tip, potentially causing tissue injury. The recall affects 140 units distributed in the US and internationally.

    Product
    NEO-KATH(TM) Caudal Set, REF 201-2430, Sterile
    Category
    Medical Device
    Distribution
    8 states
  • CriticalFDA (Devices)·Z-2188-2021·2021-08-18

    FDA Recalls HeartWare HVAD Pump Implant Kit for Neurological Events and Mortality

    Medtronic is recalling the HeartWare HVAD Pump Implant Kit due to higher rates of neurological adverse events and mortality compared to other heart pump devices. The pump may also delay or fail to restart.

    Product
    HeartWare HVAD Pump Implant Kit, REF 1103
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2192-2021·2021-08-18

    HeartWare HVAD System Recalled Due to Higher Mortality Rates

    Medtronic is stopping the HVAD System due to observational data showing higher mortality rates and neurological adverse events compared to other cardiac assist devices. The internal pump may also delay or fail to restart.

    Product
    HeartWare HVAD Driveline Extension Cable, REF 100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2194-2021·2021-08-18

    HeartWare HVAD Heart Pump Recalled for Neurological Events and Mortality

    Medtronic is recalling the HeartWare HVAD heart pump implant due to higher rates of neurological adverse events and mortality compared to other devices. The internal pump may also delay or fail to restart.

    Product
    HeartWare HVAD Implant Kit, REF 1104JP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2193-2021·2021-08-18

    HeartWare HVAD Driveline Extension Cable Recalled for Cardiac Safety Concerns

    Medtronic is recalling the HeartWare HVAD Driveline Extension Cable (443 units) due to higher frequency of neurological adverse events and mortality in clinical comparisons with other heart assist devices. The pump may experience restart delays or failures.

    Product
    HeartWare HVAD Driveline Extension Cable, REF 100US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2191-2021·2021-08-18

    HeartWare HVAD Pump Implant Kit Recalled for Increased Mortality and Device Failure

    Medtronic is recalling 163 HeartWare HVAD Pump Implant Kits distributed worldwide due to higher rates of neurological adverse events, mortality, and pump malfunction compared to other cardiac assist devices.

    Product
    HeartWare HVAD Pump Implant Kit, REF 1153
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2190-2021·2021-08-18

    HeartWare HVAD heart pump implants recalled for neurological events and mortality

    Medtronic is withdrawing 4,078 HeartWare HVAD implants worldwide due to higher frequency of neurological adverse events, mortality, and potential pump restart failures compared to other available devices.

    Product
    HeartWare HVAD Pump Implant Kit, REF 1125
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2196-2021·2021-08-18

    Heartware HVAD ventricular assist device recalled due to mortality risk

    Medtronic recalled the Heartware HVAD Outflow Graft worldwide due to higher rates of neurological events and mortality compared to other left ventricular assist devices, plus pump restart failures.

    Product
    HeartWare HVAD Outflow Graft, REF MCS1725OG
    Category
    Medical Device
    Distribution
    Distributed nationwide