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 the agency’s own highest classification or reported deaths or serious injuries, 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

9951–9975 of 27441

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-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-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-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-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-1112-2022·2022-05-25
VITROS Immunodiagnostic Hormone Reagents Recalled for Measurement Imprecision
Specific lots of VITROS FSH, LH, and Prolactin reagent kits may produce falsely high or delayed test results at low measurement levels. Affected lots distributed worldwide; labs should discontinue use and contact the manufacturer.
Product
VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922
Category
Medical Device
Distribution
Distributed nationwide
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-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-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-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-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-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-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-1108-2022·2022-05-25
VitriGuard Cryopreservation Storage Device Recalled for Sterility Risk
CooperSurgical is recalling 2,340 VitriGuard cryopreservation devices with compromised barrier seals that may compromise sterility. The affected devices were distributed across ten U.S. states.
Product
VITRIGUARD, CARRIER, CLEAR; Model. No. 43782001 The VitriGuard device is a cryopreservation storage device composed of a stick and cap.
Category
Medical Device
Distribution
10 states
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
SevereFDA (Devices)·Z-1009-2022·2022-05-18
FDA Recalls Accula SARS-CoV-2 Test for False Positive Risk
Mesa Biotech is recalling approximately 6,162 units of the Accula SARS-CoV-2 Test due to an increased risk of false positive results, which could delay correct diagnosis and treatment.
Product
Accula SARS-CoV-2 Test, REF: COV4100
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1045-2022·2022-05-18
COVID-19 Antigen Test Kit Distributed Without FDA Authorization or Clearance
The FDA is recalling 17,000 units of Joysbio SARS-CoV-2 Antigen Rapid Test Kits distributed in Alabama and Georgia. The tests were sold without FDA clearance or authorization for marketing in the United States.
Product
Joysbio SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test
Category
Medical Device
Distribution
2 states
SevereFDA (Devices)·Z-1044-2022·2022-05-18
COVID-19 Rapid Antigen Test Kits Recalled for Unauthorized Distribution
Woodside Acquisitions Inc. recalled 34,240 Oral Rapid SARS-CoV-2 Antigen Test Kits distributed in Alabama and Georgia. The tests were distributed without FDA clearance or authorization for marketing.
Product
Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit; COVID 19 Test
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1057-2022·2022-05-18
Chemotherapy Infusion Bag Adaptor May Disconnect and Spill Hazardous Drugs
Simplivia Healthcare is recalling OnGuard2 CSTD Bag Adaptors because they may disconnect from infusion bags, potentially spilling hazardous medications.
Product
OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product, Product code MG412143
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1043-2022·2022-05-18
Medtronic IN.PACT AV Balloon Catheter: Damaged Packaging May Affect Sterility
Medtronic is recalling IN.PACT AV paclitaxel-coated balloon catheters because packaging damage may result in loss of sterility. The devices were distributed worldwide and in the United States.
Product
Medtronic IN.PACT AV, Paclitaxel-coated PTA Balloon Catheter, REF: IAV06008008P, Sterile EO, Rx Only
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1059-2022·2022-05-18
VITEK 2 Systems Software Issue May Produce Incorrect Antibiotic Test Results
bioMerieux VITEK 2 bacterial identification systems have a software defect where antibiotic susceptibility and synergy test results transmitted to laboratory systems may omit user or automated corrections, potentially leading to incorrect test interpretation.
Product
VITEK 2 Systems and VITEK 2 with MYLA.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1055-2022·2022-05-18
Flexible Bronchoscope Recalled Due to Inadequate Disinfection Process
Karl Storz is recalling flexible bronchoscopes due to potential failure of the disinfection process. The devices may not eliminate microorganisms adequately, posing an infection risk to patients.
Product
11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1053-2022·2022-05-18
Ethicon STRATAFIX Surgical Sutures Recalled for Incorrect Needle Type and Size
Ethicon is recalling STRATAFIX surgical sutures (lots AAHM529 and AAHQ049) due to component mix-ups resulting in incorrect needle types, sizes, or suture lengths. 2,808 units distributed internationally are affected.
Product
STRATAFIX SPIRAL PGA-PCL UNI UD sizes: [20CM USP2-0(M3) S/A RB-1, product code: SXMD1B403-12] and [30CM USP2-0(M3) S/A PS-1, product code: SXMD1B100-12].
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1074-2022·2022-05-18
Phototherapy Units Recalled for Software Bug Causing Incorrect Dosing
Daavlin's 4 Series CX phototherapy units are recalled due to a software defect that can cause incorrect dosing (over or under) when resuming interrupted treatments.
Product
4 Series CX phototherapy units equipped with Daavlin's ClearLink Control System software versions v3.03h and 3.04v. M4 Ser CX 311-20 120-240V 50/60Hz, item # 807QS0020CX6.
Category
Medical Device
Distribution
Distributed nationwide

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9951–9975 of 27441