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

5901–5925 of 13512

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-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-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-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-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-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-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-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-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-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
ModerateFDA (Devices)·Z-2245-2024·2024-07-10
Medical Device Calibrator Kit Assigned Extended Incorrect Expiration Date
Ortho-Clinical Diagnostics is recalling a calibrator kit with an incorrect expiration date that could bias lab results if used past its true expiration date.
Product
VITROS Chemistry Products Calibrator Kit 29- In-Vitor used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of total iron-binding capacity (TIBC) using VITROS Chemistry Products dTIBC Reagent Mo
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-2233-2024·2024-07-10
Operating Room System Recalled for Incomplete Electrical Safety Testing Records
Olympus has recalled 227 EasySuite 4K operating room systems worldwide due to incomplete documentation of earth leakage testing, which is required to confirm electrical current levels are within safety standards.
Product
EasySuite 4K Integrated Operating Room System Model/Catalog Number: EasySuite 4K- The EasySuite 4K system includes a touch panel user interface for quick routing of 2K/4K procedural video to displays within the operating room and for convenient control of room video cameras, sur
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
CriticalFDA (Devices)·Z-2140-2024·2024-07-03
Life2000 Ventilator systems recalled due to battery charging failure risk
The Life2000 Ventilator may fail to charge or experience intermittent charging behavior due to damage to the battery charger dongle. This FDA Class I recall affects approximately 2,510 units distributed nationwide.
Product
Life2000 Ventilator, Product Code: MS-01-0118, which is contained in the Life2000 Ventilator System, with Product Codes BT-20-0002, BT-20-0002A and BT-20-0002AP. The Life2000 ventilation system includes the Life2000 ventilator which has its individual label.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2165-2024·2024-07-03
Philips SENSE XL Torso Coil 1.5T Recalled for Overheating Risk
Philips recalled 14 SENSE XL Torso Coils worldwide due to potential overheating. The coils could heat up during use and cause patient burn injuries.
Product
SENSE XL TORSO COIL 1.5T Mk2. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567502281, 453567502282, 453567502283, 453567502284, 453567502285, 453567502286, 459801585212.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2164-2024·2024-07-03
Philips MR Torso Coil Recall: Potential Patient Burn Risk
Philips is recalling 307 SENSE XL TORSO COIL 3.0T units used in MR imaging systems worldwide due to potential for coils to overheat and cause patient burn injuries.
Product
SENSE XL TORSO COIL 3.0T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567394941, 453567394942, 453567394943, 453567394945, 459801593182. Coils may be included in kits with Mode Numbers: 989603050641, 98960
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2159-2024·2024-07-03
Inspire Model 3028 Implantable Pulse Generator Manufacturing Defect
Inspire Medical Systems recalls the Model 3028 Implantable Pulse Generator due to a manufacturing defect causing electrical leakage and system malfunction that requires revision surgery. The recall affects 24 devices distributed in the US and Germany.
Product
Inspire Model 3028, IV Implantable Pulse Generator
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2163-2024·2024-07-03
Philips SENSE XL TORSO COIL Recall Due to Potential Patient Burn Hazard
Philips is recalling SENSE XL TORSO COIL units used in MRI imaging because the coils may heat up excessively and cause patient burns. This FDA Class I recall affects 729 units distributed worldwide.
Product
SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567141882, 453567141883. Coils may be included in kits with Mode Numbers: 989603014351 & 989603014352.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2201-2024·2024-07-03
Medtronic MIRRO MRI implantable defibrillator recalled for weld defect
Medtronic is recalling 3 MIRRO MRI DR SureScan implantable cardioverter defibrillators due to a manufacturing weld crack that caused devices to fail quality checks. The defect was detected during manufacturing before devices reached patients.
Product
MIRRO MRI DR SureScan, Model Number DDME3D1, Implantable Cardioverter Defibrillator
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2168-2024·2024-07-03
GE CARESCAPE Canvas monitors may lose display following power loss events
GE Healthcare medical monitors may fail to display following a power loss event after CPU battery replacement, potentially delaying patient condition recognition.
Product
CARESCAPE Canvas 1000, Model Numbers: a) 5865770; b) 5865770-01040169; c) 5865770-01054142; d) 5865770-01054696; e) 5865770-01054698; f) 5865770-01054721; g) 5865770-01054740; h) 5865770-01055202; i) 5865770-01055204; j) 5865770-01055270; k) 5865770-01055317; l) 5865
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2205-2024·2024-07-03
Medtronic MIRRO MRI ICD devices recalled for manufacturing weld crack defect
Medtronic recalls 13 MIRRO MRI VR SureScan implantable cardioverter defibrillators (ICDs) due to a manufacturing weld crack. The defect was identified and caused device failure during the manufacturing leak check quality control test.
Product
MIRRO MRI VR SureScan, Model Number DVME3D4, Implantable Cardioverter Defibrillator
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2195-2024·2024-07-03
Medtronic Implantable Defibrillator Recalled for Manufacturing Weld Defect
Medtronic recalls 26 units of CROME HF QUAD CRT-D implantable defibrillators worldwide due to weld cracks discovered during manufacturing quality control. Devices were contained before reaching patients.
Product
CROME HF QUAD CRT-D MRI SureScan, Model Number DTPC2QQ, Implantable Cardioverter Defibrillator
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2221-2024·2024-07-03
Endoscopic Kittner Surgical Instrument Recalled for Sterile Barrier Defect
ASPEN SURGICAL is recalling 1,900 units of the Endoscopic Kittner Blunt Dissecting Instrument (Model KT-9101) due to a potential defect in the sterile barrier seal.
Product
Endoscopic Kittner Blunt Dissecting Instrument, Intended to be used for blunt dissection of tissue, Model Number KT-9101
Category
Medical Device
Distribution
Distributed nationwide

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5901–5925 of 13512