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

11076–11100 of 27441

HighFDA (Devices)·Z-2343-2021·2021-09-01
Diagnostic MRI system recalled for pressure relief valve defect
A Philips Ingenia MRI system has been recalled due to installation of a 42 psi pressure relief valve instead of the correct 3.75 psi valve, which may result in helium gas release and injury.
Product
Ingenia 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model Number…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2344-2021·2021-09-01
Philips Ingenia MRI System Equipped With Incorrect Pressure Relief Valve
Philips Ingenia Elition X MRI systems contain an incorrectly installed pressure relief valve that may release helium gas and cause injury. The recall affects 6 U.S. units and 12 units distributed internationally.
Product
Ingenia Elition X-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2354-2021·2021-09-01
Accu-Chek Inform II glucose test strips may open during shipment
Roche Diabetes Care is recalling Accu-Chek Inform II glucose test strips because vials may open during shipment, exposing strips to humidity and potentially causing inaccurate test results.
Product
Accu-Chek Inform II Test Strip, Whole Blood Glucose Test System, Model number 05942891001
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2353-2021·2021-09-01
Accu-Chek SmartView Test Strips May Open During Shipment
Roche is recalling Accu-Chek SmartView Test Strip vials that may open during shipment. The vials can be exposed to humidity, damaging the strips and potentially causing inaccurate glucose readings.
Product
Accu-Chek SmartView Test Strip, Blood Glucose Monitoring System, Model numbers: 06337538001, 06337546001, 06337562001
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2351-2021·2021-09-01
Accu-Chek Aviva Plus Test Strips Recalled for Potential Inaccurate Glucose Readings
Roche Diabetes Care is recalling Accu-Chek Aviva Plus Test Strips because vials may open during shipment, exposing strips to humidity and causing inaccurate glucose readings that could lead to improper treatment decisions.
Product
Accu-Chek Aviva Plus Test Strip, Blood Glucose Monitoring System, Model numbers: 06908152001, 06908217001, 06908268001, 06908349001, 06908373001
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2332-2021·2021-09-01
Laboratory Data Management Software Recalled for Potential Patient Result Errors
Beckman Coulter's Normand Remisol Advance Data Manager software versions 2.0 and 2.1 may add extra cells to patient requests, potentially causing erroneous patient results in clinical laboratories.
Product
Normand Remisol Advance Data Manager, REF: C69412, C69413, C44703, and C57017 is a software device that interfaces between laboratory information systems (LIS) and laboratory instruments.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2335-2021·2021-09-01
AUGMENT Injectable Kit Recalled for Wrong Vial Tray in Package
BioMimetic Therapeutics is recalling AUGMENT Injectable Kits (Model K30003010, Lot 1706343) because some packages contain the wrong vial tray. The recall affects 499 units distributed nationwide.
Product
AUGMENT Injectable Kit, 3cc, Model K30003010, Lot 1706343
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2341-2021·2021-09-01
MRI System Pressure Relief Valve Defect May Release Helium Gas
Philips MRI systems contain an incorrectly rated pressure relief valve that may release helium gas and cause injury. The system was installed with a 42 psi valve instead of the required 3.75 psi valve.
Product
Ingenia 1.5T Evoluton- Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2345-2021·2021-09-01
MRI System Pressure Valve Installation Error Poses Helium Release Risk
A wrong pressure relief valve was installed in Ingenia CX 3.0T MRI systems, which may release helium gas and cause injury to patients and staff.
Product
Ingenia CX 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2340-2021·2021-09-01
Gore Balloon Catheter Leakage Recall Affects 3,364 Units Worldwide
W.L. Gore is recalling 3,364 units of its Molding & Occlusion Balloon Catheter due to leakage from the guidewire lumen and y-hub that can prevent proper inflation. No injuries have been reported.
Product
Gore Molding & Occlusion Balloon Catheter, REF Catalogue Number MOB37, SN XXXXXXXX, 10 mm - 37 m 10 Fr, Guidewire Compatibility 0.035", STERILE EO, CE2797, UDI: (00)733132639489
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2355-2021·2021-09-01
HARMONIC HD 1000i Surgical Shears Recalled for Potential Burn Risk
Ethicon is recalling HARMONIC HD 1000i Shears because an internal component may crack and lodge behind the power button, causing continuous unintended activation and potential burns. Affected users should discontinue use immediately.
Product
HARMONIC HD 1000i Shears (20cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. Product Code: HARHD20
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2342-2021·2021-09-01
Philips Ingenia MRI System recalled due to incorrect pressure relief valve
Philips recalled 27 units of the Ingenia 1.5T Magnetic Resonance system with an incorrect pressure relief valve (42 psi instead of 3.75 psi) that could release helium gas and cause injury.
Product
Ingenia 1.5T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model Number…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2338-2021·2021-09-01
MRI System Table Pads Missing Required Natural Rubber Allergen Label
Table pads in Hitachi's ECHELON Oval MRI System contain natural rubber but lack required labeling on packaging and in user manuals. Federal regulations under 21 CFR 801.437 mandate disclosure of this material.
Product
ECHELON Oval MRI System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2347-2021·2021-09-01
MRI System Pressure Relief Valve Installation Error May Release Helium Gas
Philips MRI systems may have incorrect pressure relief valves installed, risking helium gas release and injury. Seven units contain 42 psi valves instead of required 3.75 psi valves.
Product
Ingenia Elition S-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2346-2021·2021-09-01
MRI System Pressure Relief Valve Defect May Cause Helium Release
Philips Achieva 3.0T MRI systems may have an incorrectly installed pressure relief valve that could release helium gas and cause injury. Affected units are distributed in the United States and internationally.
Product
Achieva 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model Number…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2348-2021·2021-09-01
Orthopedic knee replacement stem: wrong size provided in mislabeled packaging
DePuy Orthopaedics recalled 7 units of ATTUNE REVISION CEMENTED STEM (16×80mm) because packages labeled as 16×80mm contained 16×130mm stems instead. This size mismatch could cause improper implantation if not caught before surgery.
Product
ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 1512-16-080
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2331-2021·2021-09-01
FDA Recalls AltiVate Shoulder Implant System Due to Component Mating Failure
The FDA is recalling AltiVate Anatomic Shoulder Systems due to humeral stem components that may fail to mate properly with broach handles, potentially delaying surgery or requiring revision.
Product
AltiVate Anatomic Shoulder System for the following Part Numbers: 1. Part # 520-08-00, Rev. C., 2. Part # 520-10-000, 3. Part # 520-12-000, 4. Part # 520-14-000, 5. Part # 520-16-000
Category
Medical Device
Distribution
35 states
HighFDA (Devices)·Z-2350-2021·2021-09-01
Terumo Advanced Perfusion System Electronic Patient Gas System Recalled for Control Failure
The Terumo Advanced Perfusion System 1 Electronic Patient Gas System is recalled for intermittent initialization failures that disable the primary control interface, requiring use of backup local controls.
Product
Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 801188
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2349-2021·2021-09-01
Vascular Ultrasound Examination Table Recalled for Weld Failure
Oakworks vascular ultrasound examination tables (models USV1 and USV2) are recalled due to potential weld failure in the tilting mechanism bracket. A failed weld could prevent the table from tilting, affecting patient positioning.
Product
Vascular Table without Fowler (USV1) and Ultrasound Vascular Table with Fowler (USV2). Intended Use: Vascular Ultrasound examination table Catalog Number: 66783 and 64219
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2337-2021·2021-09-01
ECHELON MRI System Recalled for Missing Natural Rubber Allergen Labeling
Hitachi Healthcare Americas is recalling ECHELON MRI System table pads because packaging and user manuals lack required disclosure that the pads contain dry natural rubber, a potential allergen. No illnesses have been reported.
Product
ECHELON MRI System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2330-2021·2021-09-01
AQUABEAM Handpiece scope tube tip may detach during procedures
PROCEPT BIOROBOTICS is recalling AQUABEAM Handpieces (model HP2000) because the scope tube tip may detach during use, potentially requiring procedural delay or additional intervention to remove the tip from the bladder or prostate.
Product
AQUABEAM Handpiece, REF: HP2000, a sterile single-use component of the AQUABEAM Robotic System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2356-2021·2021-09-01
Surgical Shears HARMONICHD 1000i Recalled Due to Component Defect and Burn Risk
Ethicon is recalling HARMONICHD 1000i Shears due to a cracked internal component that may cause continuous device activation and result in burns. About 68,960 units have been distributed worldwide.
Product
HARMONICHD 1000i Shears (36cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. Product Code: HARHD36
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2352-2021·2021-09-01
Accu-Chek Performa Test Strips Recalled Due to Defective Packaging
Roche Diabetes Care is recalling Accu-Chek Performa test strips because vials may open during shipment, exposing strips to humidity and causing inaccurate glucose readings that could lead to inappropriate diabetes treatment decisions.
Product
Accu-Chek Performa Test Strip, Blood Glucose Monitoring System, Model number 07299702001
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2244-2021·2021-08-25
Argyle UVC Insertion Tray Recalled for Safety Scalpel Locking Defect
Cardinal Health's Argyle UVC Insertion Tray, used for neonatal umbilical catheter insertion, lacks proper instructions for the included Safety Scalpel N11. Once locked, clinicians cannot unlock it, potentially delaying critical treatment.
Product
Argyle UVC Insertion Tray containing Safety Scalpel N11 (vendor part number 73-1811). Intended for use to insert an Umbilical Venous Catheter (UVC) into the umbilical artery or vein of neonate. Product Code: 43201
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2326-2021·2021-08-25
Surgical stapler mislabeled with incorrect device size
Ethicon is recalling ECHELON FLEX Powered Plus Staplers because the product packaging is mislabeled; packages labeled as 60mm contain 45mm devices, which could affect surgical outcomes if the incorrect size is used.
Product
ECHELON FLEX Powered Plus Stapler-intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. Product Code: PSEE60A
Category
Medical Device
Distribution
Distributed nationwide

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11076–11100 of 27441