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 13512

SevereFDA (Devices)·Z-2248-2024·2024-07-10
Megadyne MEGA 2000 Patient Return Electrode recalled for burn risk
Megadyne is recalling the MEGA 2000 Patient Return Electrode due to identified potential risk of patient burns. Use is now restricted to patients aged 12 or older.
Product
Brand Name: MEGADYNE" MEGA 2000" Patient Return Electrode Product Name: MEGADYNE" MEGA 2000" Patient Return Electrode Model/Catalog Number: 0800 Software Version: N/A Product Description: Reusable Patient Return Electrode, Mega 2000, Adult, For Patients Weighing over 25lbs. (
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-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-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-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-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-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-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-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-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-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-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
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-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-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-2264-2024·2024-07-10
Immunoassay Analyzer Software Defect May Cause Incorrect Test Calibration
Beckman Coulter is recalling 116 DxI 9000 Immunoassay Analyzers due to a software defect that fails to properly validate calibrator barcodes, potentially resulting in incorrect calibration curves and erroneous patient test results.
Product
DxI 9000 Access Immunoassay Analyzer, C11137; in-vitro diagnostic
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2228-2024·2024-07-10
Medline Surgical Kits Recalled for Weak Seals Compromising Sterility
Medline is recalling 12,588 sterile surgical kits with Pure Pouch components that have weak seals, potentially compromising sterility and exposing patients and surgical teams to non-sterile instruments.
Product
Sterile convenience kits: a. Medline Retrograde PK-22025203-LF, Pack #DYNJ47873K, containing a Pure Pouch containing component Sterile Curved Kelly Hemostat, Reorder #66175. b. Medline Cath Lab Pack, Pack #DYNJ56141A, containing a Pure Pouch containing component Medline D
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-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-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-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-2262-2024·2024-07-10
BD Alaris System Manager Software Connectivity Issue Recalled Nationwide
A software issue in BD Alaris System Manager version 12.5.1 may prevent the PC unit from connecting to the server, potentially affecting wireless data transmission. CareFusion 303, Inc. is recalling the affected software version nationwide.
Product
BD Alaris System Manager REF: 9601, compatible with BD Alaris PC Units
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-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-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

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5876–5900 of 13512