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

11676–11700 of 13717

SevereFDA (Devices)·Z-1076-2022·2022-05-25
Atrium Advanta V12 Covered Stent System Recalled for Delivery Catheter Separation
Atrium Medical is recalling the Advanta V12 Covered Stent System worldwide for potential separation of the balloon or catheter hub during withdrawal, which may cause procedural delays and serious complications including embolism and organ infarction.
Product
Atrium Advanta V12 Covered Stent System (OUS only). Product Code/Part Number: 85320 85321 85322 85323 85324 85325 85326 85327 85328 85329 85330 85331 85332 85333 85334 85335 85336 85337 85338 85339 85340 85341 85342 85343 85344 85345 85350 85351 85352 85353 85354 85355 85360
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1095-2022·2022-05-25
Dragonfly OpStar Imaging Catheter Recall Due to Proximal Marker Separation Risk
Abbott Vascular recalls 14,544 Dragonfly OpStar Imaging Catheters due to potential separation of the proximal marker. The affected devices were distributed throughout the US and internationally.
Product
Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EO
Category
Medical Device
Distribution
44 states
HighFDA (Devices)·Z-1082-2022·2022-05-25
EXALT Model D Single-Use Duodenoscope: Updated Instructions for Perforation Risk
Boston Scientific issued updated instructions for the EXALT Model D Single-Use Duodenoscope to highlight the known risk of perforation and provide best practices for safe insertion, advancement, and removal.
Product
EXALT Model D Single-Use Duodenoscope (Box 2) UPN: M0054242CE1 Intended Use: sterile, single-use, flexible video duodenoscope intended for use with the EXALT" Controller to examine duodenum and perform various procedures within the duodenum including endoscopy and endoscopic
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1084-2022·2022-05-25
Medical Device Maker Recalls Laboratory Instrument With Incorrect Power Connector Rating
Beckman Coulter Inc. is recalling 7 MicroScan WalkAway-96 plus instruments due to an AC power connector rated for 1 ampere instead of the required 10 amperes. The underated connector could fail or overheat during normal operation.
Product
MicroScan WalkAway-96 plus Instrument REF B1018-284
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1083-2022·2022-05-25
MicroScan WalkAway-40 plus Instrument recalled for incorrect AC power connector
Beckman Coulter is recalling 22 MicroScan WalkAway-40 plus Instruments with an AC power entry connector rated at 1 ampere instead of the correct 10 amperes, creating a potential electrical hazard.
Product
MicroScan WalkAway-40 plus Instrument REF B1018-283
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1104-2022·2022-05-25
HeartWare Ventricular Assist Device controller has translation errors in Finnish, Turkish
HeartWare Ventricular Assist Device controllers in Finland and Turkey contain translation errors in displays, instructions, and patient manuals. The errors could affect proper device operation and emergency response.
Product
HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1111-2022·2022-05-25
Turbett Surgical Container TS1500 weld failures breach sterile barrier
The Turbett Surgical Container TS1500 is being recalled because eight units manufactured before June 2019 have exhibited weld failures that breach the sterile barrier during prolonged use.
Product
Turbett Surgical Container, TS1500
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-1113-2022·2022-05-25
FDA Recalls VITROS Immunodiagnostic LH Reagent Pack for measurement imprecision
Ortho-Clinical Diagnostics is recalling VITROS Immunodiagnostic Products LH Reagent Pack due to low-end imprecision that may produce falsely high or delayed patient and quality control results.
Product
VITROS Immunodiagnostic Products LH Reagent Pack Product Code: 1350198
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1092-2022·2022-05-25
Verigene Processor heating system may produce false negative results
Luminex Corporation is recalling 24 Verigene Processor SP units because the heater may operate outside established temperature limits, potentially producing false negative diagnostic results.
Product
Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system
Category
Medical Device
Distribution
16 states
HighFDA (Devices)·Z-1086-2022·2022-05-25
Medical analyzer instruments recalled for incorrect power connector rating
Beckman Coulter is recalling DxM 1096 MicroScan WalkAway Instruments because some units may have an incorrect AC power entry connector rated at 1 ampere instead of 10 amperes, posing a potential electrical safety risk.
Product
DxM 1096 MicroScan WalkAway Instrument REF B1018-496
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1099-2022·2022-05-25
Smith & Nephew knee implants recalled for labeling error
Smith & Nephew is recalling knee implants shipped in incorrect packaging—a JOURNEY II femoral implant was boxed as a LEGION NARROW PS implant. The labeling error could result in the wrong implant being used during surgery.
Product
LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1100-2022·2022-05-25
Affinity Dental Impression Material Recalled for Wrong Material
Clinician's Choice Dental Products is recalling Affinity Hydroactive Impression Material Heavy Body Regular Set because Template Ultra Quick matrix Material was packaged instead of the indicated Heavy Body viscosity. The recall affects 46 units distributed in South Carolina.
Product
Affinity Hydroactive Impression Material Heavy Body Regular Set 12PK- A vinyl poly siloxane material used to create, via impression, a reproduction of tooth and gum structure. Product ID: 013912
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1116-2022·2022-05-25
Olympus Uretero-reno Videoscope Bending Section May Crack and Deform
The bending section of the Olympus URF-V2 videoscope may crack and develop abnormal shape or angulation. This could affect the device's function during urological procedures.
Product
Olympus Uretero-reno videoscope, Model No. URF-V2
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1094-2022·2022-05-25
Nurse Call System Recall Due to Firmware Memory Leak
Baxter Healthcare is recalling 1,414 Voalte Nurse Call System units distributed to North Carolina and Virginia due to a firmware memory leak in a supplier-manufactured component.
Product
Voalte Nurse Call System provides a comprehensive communication and information system that places patient calls, staff calls, and emergency calls.
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1085-2022·2022-05-25
Medical diagnostic instrument recalled for electrical connector assembly defect
Beckman Coulter is recalling 40 DxM 1040 MicroScan WalkAway laboratory instruments due to an assembly defect: some units have an AC power connector inlet rated at 1 ampere instead of the correct 10-ampere rating, which could impair power delivery.
Product
DxM 1040 MicroScan WalkAway Instrument REF B1018-440
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1105-2022·2022-05-25
HeartWare HVAD Controller: Translation Errors in Critical Documentation
The FDA is recalling 59 units of HeartWare HVAD System Controller due to translation errors in Finnish and Turkish in device displays and critical documentation including patient manuals and emergency responder guides.
Product
HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420-Controller 2.0
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1114-2022·2022-05-25
VITROS Prolactin Reagent Recalled for Low-End Measurement Imprecision
Ortho-Clinical Diagnostics is recalling VITROS Prolactin Reagent packs due to low-end measurement imprecision that may cause falsely high or delayed test results. Approximately 1,767 affected units are distributed worldwide.
Product
VITROS Immunodiagnostic Products Prolactin Reagent Pack Product Code: 1849793
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1093-2022·2022-05-25
NaviCare Nurse Call System: Firmware Memory Leak in Supplier Component
Baxter Healthcare is recalling 11,028 NaviCare Nurse Call Systems distributed in North Carolina and Virginia due to a firmware memory leak in a supplier-manufactured component.
Product
NaviCare Nurse Call System provides a comprehensive communication and information system that places patient calls, staff calls, and emergency calls.
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1107-2022·2022-05-25
HeartWare HVAD Ventricular Assist Device Recalled for Translation Errors
HeartWare is recalling 645 units of HVAD Ventricular Assist Device documentation due to translation errors in Finnish and Turkish. The errors affect controller displays, patient manuals, and emergency responder guides.
Product
HeartWare Ventricular Assist Device (HVAD) System, individual pamphlets: HVAD¿ System Emergency Responder Guide (FI-Finnish) HVAD¿ System Emergency Responder Guide (FI-Finnish) HVAD¿ System Emergency Responder Guide (FI-Finnish) HVAD¿ System Emergency Responder Guide (FI-Fin
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1091-2022·2022-05-25
ATLAS Stim Headbox Recalled: Unapproved Investigational Device Without Safety Testing
Neuralynx is recalling the ATLAS Stim Headbox, a neurophysiology device distributed without FDA investigational approval or electrical safety clearance.
Product
ATLAS Stim Headbox-NK For use only with the ATLAS Neurophysiology System. CAUTION--INVESTIGATIONAL DEVICE Limited by Federal (or United States) law to investigational use. Only for use in Non-Significant Risk studies under the supervision of an IRB.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1115-2022·2022-05-25
Radiometer Arterial Blood Sampler recalled due to sterility guarantee loss
Radiometer Medical is recalling Arterial Blood Samplers (REF:956-552) because sterility cannot be guaranteed throughout the product's shelf life. The recall affects 7,228 boxes distributed worldwide.
Product
Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL, 80 IU electrolyte-balanced heparin. Not for injection. , IVD, Rx Only, Sterile EO, CE
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1117-2022·2022-05-25
Portable Oxygen Concentrator Recalled for Lack of FDA Clearance
Caire, Inc. is recalling two CAIRE FreeStyle Comfort portable oxygen concentrators because they were not cleared by the FDA for U.S. distribution. The affected devices were distributed to Puerto Rico.
Product
CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1102-2022·2022-05-25
HeartWare HVAD Ventricular Assist Device Recalled for Translation Errors
HeartWare is recalling 236 units of HVAD ventricular assist devices due to Finnish and Turkish translation errors in controller displays, instructions, and patient materials distributed in Finland and Turkey.
Product
HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1096-2022·2022-05-25
BioPlex 2200 CMV IgM Reagent Pack Recalled for Variable Test Performance
Bio-Rad Laboratories recalls the BioPlex 2200 ToRC IgM Reagent Pack (Lot 301388) due to CMV IgM analyte showing variable elevated background levels depending on reagent handling.
Product
BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1087-2022·2022-05-25
MicroScan WalkAway-40 Medical Instruments Recalled for Incorrect Power Connector Rating
Three MicroScan WalkAway-40 medical instruments were recalled because they have an AC power connector rated at 1 ampere instead of the correct 10 ampere rating. This mismatch poses a potential electrical and fire hazard.
Product
MicroScan WalkAway-40 plus Reconditioned Instrument REF B1018-340R
Category
Medical Device
Distribution
Distributed nationwide

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11676–11700 of 13717