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.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

5876–5900 of 13543

SevereFDA (Devices)·Z-2250-2024·2024-07-10
Reusable Patient Return Electrode Recalled Due to Burn Risk
MEGADYNE MEGA SOFT Dual Reusable Patient Return Electrodes are recalled due to an identified risk of patient burns. Use should be restricted to patients aged 12 or older.
Product
Brand Name: MEGADYNE" MEGA SOFT" Dual Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOFT" Dual Reusable Patient Return Electrode Model/Catalog Number: 0835 Software Version: N/A Product Description: Reusable Patient Return Electrode, Mega Soft, Dual Cord, Adu
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-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-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-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-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
0 states
HighFDA (Devices)·Z-2226-2024·2024-07-10
Medline Neuro IR Surgical Kit Recalled Due to Weak Seals
Medline is recalling Neuro IR surgical convenience kits due to weak seals in the Pure Pouch component that may compromise sterility. The recall affects 12,588 kits distributed nationwide.
Product
Sterile surgical convenience kit: Medline Neuro IR Pack, Pack #DYNJ56073C, containing a Pure Pouch with component Medline Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2263-2024·2024-07-10
Zyno Medical Z800 Series Infusion Pumps: Faulty Power Supply May Prevent Battery Charging
Certain Zyno Medical Z800 series infusion pumps contain faulty power supply modules that cannot charge the rechargeable battery. When unplugged from AC power, affected pumps may lack sufficient charge to operate.
Product
Zyno Medical Z800, Z800F, Z800W, and Z800WF Infusion Pumps
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-2258-2024·2024-07-10
Prucka 3 Amplifier capacitors could fail during cardiac monitoring procedures
Capacitors in Prucka 3 Amplifiers used with CardioLab and ComboLab cardiac systems could fail, causing display oscillations and preventing visualization of heart electrical activity waveforms.
Product
Prucka 3 Amplifier Model #P1801PA used with CardioLab AltiX electrophysiology recording system and ComboLab AltiX hemodynamic and electrophysiology recording system; and Field Replacement Units spare part #5875569 (Assy CLABIII AMP 128CH 100-240V 50-60HZ).
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-2238-2024·2024-07-10
AMT Initial Placement Dilator Set Recalled Due to Incorrect Guidewire Labeling
Applied Medical Technology is recalling 74 units of the AMT Initial Placement Dilator Set (Model IP-DIL) due to incorrect guidewire labeling. The labeling error could result in improper guidewire selection during gastrostomy placement procedures.
Product
AMT Initial Placement Dilator Set. Used to place gastrostomy devices.
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-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-2235-2024·2024-07-10
Surgical retractor blade manufacturing defect could cause bone fracture
SeaSpine Orthopedics is recalling Fathom Pedicle-Based Retractor C/C Blades due to manufacturing defects that could cause bone fracture. The recall affects 31 units distributed across nine US states.
Product
Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 50-80mm Model/Catalog Number: MR2102050 Product Description: Cranial Caudal Blade Component: Yes, a component of a retractor blade
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-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-2231-2024·2024-07-10
Medline surgical convenience kits recalled due to weak Pure Pouch seals
Medline is recalling over 7,600 Open Heart surgical convenience kits nationwide due to weak seals on the Pure Pouch component. The seals may fail and compromise the sterility of the surgical instruments inside.
Product
Non-sterile convenience kits: Medline Open Heart CDS, Pack #CDS981759C, containing a Pure Pouch with component Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2237-2024·2024-07-10
Beckman Coulter DxI 9000 Analyzer Tubing Malfunction Causes Test Errors
Beckman Coulter DxI 9000 immunoassay analyzers may produce false or delayed test results due to pneumatic tubing disconnection during operation. Nine instruments are affected across the US and Europe.
Product
Beckman Coulter DxI 9000 Access Immunoassay Analyzer is a discrete photometric chemistry analyzer for clinical use. It is an in-vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human bod
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2230-2024·2024-07-10
Medline surgical convenience kits recalled for weak seal integrity
Medline surgical convenience kits containing Pure Pouch components with weak seals may fail to maintain sterility, potentially compromising the safety of contained medical instruments. Affected kits were distributed nationwide across 23 states.
Product
Non-sterile convenience kits: a. Medline Difficult Airway Tray W/O Cook, Pack #ACC010578, containing a Pure Pouch with component Reorder #DYNJ040408, Kelly Forceps/STD STR Sterile. b. Medline Adult/Child Intubation Kit, Pack #ACC010616 and Pack #ACC010616H, containing a P
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-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-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-2240-2024·2024-07-10
Siemens ARTIS Angiography Systems Recalled for Excessive Radiation Dose
Siemens is recalling ARTIS angiography systems where the first X-ray after patient registration may use incorrect copper prefiltration, potentially resulting in higher radiation doses than intended.
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-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

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5876–5900 of 13543