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

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6776–6800 of 39968

  • HighFDA (Devices)·Z-2259-2024·2024-07-10

    Stryker Flyte Hood Protective Covers Recalled Due to Expired Products

    Stryker Corporation recalled Non-Sterile Flyte hood protective covers that were distributed expired. The affected medical device units may not function as intended.

    Product
    The Non-Sterile Flyte hood covers the user s head and neck region and is intended to be worn with commercially available gowns. The hood is donned after the Flyte helmet and before the gown, such that the hood is securely tucked inside the gown. The hood attaches to and covers th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2241-2024·2024-07-10

    Siemens ARTIS Angiography Systems May Deliver Unintended Radiation Doses

    Siemens ARTIS icono angiography systems with certain detectors may deliver higher-than-intended radiation doses in rare cases. The issue occurs when incorrect copper prefiltration is applied during initial x-ray exposure after patient registration.

    Product
    ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2267-2024·2024-07-10

    Prostate Treatment Balloons Recalled Due to Fill Volume Mislabeling

    Angiodynamics is recalling IsoLoc Prostate Immobilization Balloons (ISO-100, Lot 5402) for mislabeling. Devices have 100cc fill volume but are labeled as ISO-60 (60cc).

    Product
    IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2246-2024·2024-07-10

    Portable X-Ray Cart Positioning Arm Bolt May Come Loose and Fall

    First Source Inc is recalling the First Source Vision M portable X-ray cart because the bolt securing the positioning arm to the gas spring may come loose and fall onto a patient.

    Product
    First Source Vision M. Portable cart and platform that supports an X-ray system and laptop computer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2266-2024·2024-07-10

    VITROS Chemistry FS Diluent Pack 3 Recalled for Negatively Biased Test Results

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry FS Diluent Pack 3, Lot 01-1645, because it may produce negatively biased results when used with CRP slides, potentially affecting patient diagnosis and care.

    Product
    VITROS Chemistry Products FS Diluent Pack 3, Model/Catalog Number: 6801754. Product Description: VITROS Chemistry Products FS Diluent Pack 3 comes with 3 packs per sales unit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2166-2024·2024-07-10

    HORIBA Fluorolog-QM Fluorescence Instrument Laser Safety Defect Recall

    HORIBA recalled 4 Fluorolog-QM fluorescence instruments due to a laser safety defect. A plastic cap instead of a proper beam stop may allow a Class 4 laser beam to exit the protective enclosure.

    Product
    HORIBA custom configured fluorescence instrument, modular Fluorolog-QM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2232-2024·2024-07-10

    Medline Surgical Convenience Kits Recalled for Weak Seal Compromise

    Medline recalled 7,673 surgical convenience kits nationwide due to weak seals in the Pure Pouch component that may compromise sterility of surgical instruments. No injuries have been reported.

    Product
    Non-sterile convenience kits: a. Medline CC Drawer 4 IV Circulation, Pack #ACC010254B, containing a Pure Pouch component DYND04000, O.R. Scissors S/B, 5.5 Sterile. b. Medline Code Cart Drawer 2 Adult Kit, Pack ACC010365A, containing a Pure Pouch component DYNJ04048, Kelly
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2256-2024·2024-07-10

    BD Pyxis automated dispensing cabinets with noncertified power strips

    BD Pyxis automated dispensing cabinets were shipped with socket-outlet power strips that lack IEC electrical certification, potentially exposing users to leakage currents and electric shock.

    Product
    BD Pyxis, Name/REF: BD PYXIS MB TOWER MAIN/ 169-153, BD PYXIS MB TOWER MAIN CR/ 169-154, BD PYXIS MB TOWER MAIN W/MP/ 169-157, BD PYXIS MB TWR MN 1FM-10HH-1FH MP/ 169-143, BD PYXIS MB TWR MN 2FH-1FM-4HH-2FM MP/ 169-145, BD PYXIS MB TWR MN 2FM-8HH-1FH MP/ 169-144, BD PYXIS MB TWR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2257-2024·2024-07-10

    Nalu Neurostimulation Kits Recalled for Manufacturing Defect and Device Failure

    Nalu Medical recalls 13 neurostimulation and peripheral nerve stimulation kits due to a manufacturing defect that may prevent the implantable pulse generator from functioning, stopping pain signal inhibition.

    Product
    Neurostimulation Kit (Ported, Dual 8, 40 cm), REF: 71005-US Peripheral Nerve Stimulation Kit (Ported, Dual 8, 40 cm), REF: 71019-US Components of the Nalu Spinal Cord Stimulation System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2224-2024·2024-07-10

    Medline surgical convenience kits recalled for weak seal defects

    Medline Industries is recalling 12,588 sterile surgical convenience kits due to weak seals on Pure Pouch components that may breach sterility. Products were distributed nationwide across 23 states.

    Product
    Sterile surgical convenience kits: a. Medline Cath Lab Special Procedure, Pack #00-RDF0360, containing a Pure Pouch with component Medline Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile. b. Medline Angiography Pack, Pack #DYNJ26488W, containing a Pure Pouch with compo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2244-2024·2024-07-10

    MicroPort Knee Implant Recall: Wrong Size Component in Packaging

    MicroPort's EVOLUTION MP knee implants recalled due to one confirmed case where a Size 3 left-side component was packaged in a Size 4 right-side box. No injuries reported; distribution is limited to China with no U.S. inventory.

    Product
    EVOLUTION¿ MP Femoral CS/CR Non-Porous Non-porous MicroPort total knee replacement implants are for cemented use only.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2239-2024·2024-07-10

    Avalon Ultrasound Transducers Recalled for Inaccurate Fetal Heart Rate Monitoring

    Philips is recalling Avalon ultrasound transducers used for monitoring fetal heart rate. The device may produce inaccurate measurements when monitoring multiple fetuses, potentially delaying detection of fetal distress.

    Product
    Avalon Ultrasound Transducer. Directs low-energy ultrasound beam toward the fetal heart and externally monitors fetal heart rate.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2225-2024·2024-07-10

    Sterile surgical kits recalled due to weak pouch seals risking contamination

    Medline sterile surgical kits are being recalled nationwide due to weak seals in the Pure Pouch component that may allow sterility breach. The recall affects 12,588 units distributed across 23 states.

    Product
    Sterile surgical convenience kit: Medline Retrograde PK-22025203-LF, Pack #DYNJ47873L, containing a Pure Pouch with component Sterile Curved Kelly Hemostat, Reorder #66175.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2236-2024·2024-07-10

    Acumatch L-Series Hip Implant Liners Recalled for Packaging Defect

    Exactech is recalling Acumatch L-Series hip implant liners because some units were packaged without the specified protective ethylene vinyl alcohol (EVOH) layer, which is required for proper device protection.

    Product
    Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numbers: a) 100-22-19, SZ. L; b) 100-22-20, SZ. M; c) 100-22-21, SZ. N; d) 100-22-22, SZ. P; e) 100-22-23, SZ. R; f) 100-22-24, SZ. S; g) 100-22-25, SZ. T
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2261-2024·2024-07-10

    Stryker Corporation Recalls Expired Sterile Surgical Cannula Devices

    Stryker Corporation has recalled expired sterile cannula devices distributed nationwide. The devices were past their expiration date, potentially compromising sterility and device safety.

    Product
    This product is a single use sterile device that is used to direct the lesion to the targeted site. Each cannula contains a stylet that is removed once the cannula is placed. The electrode is then inserted into the cannula. Catalog Number: 0406-630-225
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2255-2024·2024-07-10

    BD Pyxis Medication Cabinets Recalled for Uncertified Power Strip Safety Risk

    BD Pyxis MEDBANK medication cabinets contain power strips not certified to electrical safety standards, potentially exposing users to leakage currents. The recall affects 677 units distributed nationwide.

    Product
    BD Pyxis, Name/REF: MEDBANK MINI 1FH-1FM/ 169-137, MEDBANK MINI 1FH-2HH MEDPASS/ 169-151, MEDBANK MINI 1HH-1FH-1HM/ 169-101, MEDBANK MINI 1HH-1HM-1FM/ 169-102, MEDBANK MINI 1HH-3HM/ 169-103, MEDBANK MINI 2FH/ 169-104, MEDBANK MINI 2FM/ 169-105, MEDBANK MINI 2HH-1FH/ 169-
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2227-2024·2024-07-10

    Medline Birthing Room Pack surgical kits recalled due to weak sterile seals

    Medline is recalling approximately 12,588 sterile surgical kits used for childbirth procedures because weak seals on Pure Pouch components may fail and compromise sterility.

    Product
    Sterile convenience kit: Medline Birthing Room Pack, Pack #DYNJ38429D, containing a Pure Pouch component Sterile Sharp/Blunt Scissors 5.5", Reorder #65945 and containing a Pure Pouch component Sterile 5.5" Episiotomy Scissors, Reorder #67645.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2229-2024·2024-07-10

    Surgical Convenience Kits Recalled for Weak Seals Affecting Sterility

    Medline Industries recalls 7,673 surgical convenience kits due to weak Pure Pouch seals that may compromise sterility. Kits were distributed nationwide to healthcare facilities.

    Product
    Nonsterile convenience kits: a. Medline Delivery, Pack #DYNJ901130I, containing a Pure Pouch with component Reorder #DYND04000, O.R. Scissors, S/B, 5.5 Sterile. b. Medline C-Section, Pack DYNJ902938J, containing a Pure Pouch with component Reorder #DYND04000, O.R. Scissor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2247-2024·2024-07-10

    X-ray cart positioning arm bolt may loosen and fall onto patient

    A bolt securing the positioning arm on First Source iQ Flex M X-ray carts may come loose and fall onto patients. The recall involves 137 units distributed across the US, Korea, and Serbia.

    Product
    First Source iQ Flex M. Portable cart and platform that supports an X-ray system and laptop computer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2234-2024·2024-07-10

    Fathom Pedicle Retractor Blades Recalled for Manufacturing Defect

    SeaSpine Orthopedics recalls Fathom Pedicle-Based Retractor C/C Blades due to manufacturing defects that could cause bone fracture or damage during surgery. 21 units were distributed nationwide.

    Product
    Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 35-55mm Model/Catalog Number: MR2102035 Product Description: Cranial Caudal Blade Component: Yes, a component of a retractor blade
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2265-2024·2024-07-10

    Abbott Liberta RC Pulse Generator Unexpectedly Shuts Down Periodically

    Abbott Liberta RC implantable pulse generators used for deep brain stimulation may unexpectedly turn off approximately every 50 days after activation, resulting in loss of therapy. Approximately 302 units have been recalled nationwide.

    Product
    Abbott Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, RxONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2268-2024·2024-07-10

    Stryker Diagnostic Electrophysiology Catheters Recalled for Testing Failure

    Stryker Sustainability Solutions is recalling 6 units of BW Lasso 2515 NAV eco Variable Diagnostic EP Catheters because they do not meet FDA testing requirements. The devices were distributed to Japan.

    Product
    Stryker Sustainability Solutions, BW Lasso 2515 NAV eco Variable Diagnostic EP Catheter, REF: D134301, ELECTRODES: 22, spacing:2-6-2MM, Length 115 cm, STERILE.EO, Rx Only
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2242-2024·2024-07-10

    ARTIS Angiography Systems Recalled for Potential Radiation Overdose

    Siemens ARTIS icono angiography systems with specific detector configurations may deliver higher radiation doses than intended in rare cases. The issue occurs during the first X-ray exposure after patient registration.

    Product
    ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2243-2024·2024-07-10

    WOM Tube Set for Irrigation Recalled Due to RFID Tag Data Error

    WOM Tube Set for Irrigation (1700 units, Lots 4030902 and 4030903) is recalled due to incorrect RFID tag data that causes an error message preventing use in endoscopic surgeries, potentially resulting in surgical delays.

    Product
    WOM Tube Set for lrrlgatlon, single-use- Intended to transport irrigation fluid to the patient in endoscopic surgeries. Distr. by Endoscopy Smith & Nephew Inc. REF Numbers: T0449-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2260-2024·2024-07-10

    Stryker Curved Cement Delivery Needles Recalled: Expired Products Distributed

    Stryker recalled its Curved Cement Delivery Needle (Lot 6659783) due to expired product distribution. Three units were distributed to customers in Arkansas, California, Colorado, Florida, and Michigan.

    Product
    Curved, super elastic cement delivery needle that passes through the cannula in a straight configuration and enters the vertebral body in a curved configuration. This provides physicians with the ability to inject bone cement into multiple different areas through a single point o
    Category
    Medical Device
    Distribution
    Distributed nationwide