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

12226–12250 of 27470

HighFDA (Devices)·Z-0938-2021·2021-02-10
Alung Technologies Recalls Hemolung Respiratory Assist System Infusion Pumps
Alung Technologies is recalling 101 Hemolung Respiratory Assist System units due to potential delivery inaccuracy in the CME BodyGuard 323 infusion pump component.
Product
ALung Technologies Hemolung Respiratory Assist System (RAS) with CME BodyGuard 323 Infusion Pump(EUA) - Product Usage: an off-the-shelf infusion pump and administration set to provide a 30 mL/hr continuous saline flush to the integrated blood pump bearing.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0952-2021·2021-02-10
Topcon Harmony Referral System Recalled for Patient Data Mixing
Topcon Medical Systems is recalling 13 Harmony Referral System units because software flaws allowed non-unique patient IDs to merge distinct patient records and images.
Product
Harmony Referral System (aka Harmony RS)/ Medical Device Data System - Product Usage: intended to be used by trained healthcare professionals and clinicians to access archived multimedia data, forms and patient information.
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-0947-2021·2021-02-10
Philips EPIQ Ultrasound Systems Recalled for Control Panel Failure Risk
Philips is recalling 12,080 EPIQ Diagnostic Ultrasound Systems because the control panel arm assembly may break off if subjected to undue force.
Product
Philips EPIQ Diagnostic Ultrasound System, Models EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx & EPIQ CVxi - Product Usage: the systems can assist the interventionist and surgeon with image guidance during treatment of cardiovascular disease in…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0612-2020·2021-02-03
Enztec Femoral Impactor Recall Due to Arm Fracture Risk
Enztec Limited is recalling 312 femoral impactors used with the DJO EMPOWR 3D KNEE system because the arm may fracture during use, potentially causing surgical delays or inflammatory responses.
Product
REF 800-05-035, ENZTEC FEMORAL IMPACTOR - DJO, (01) 09421028110624 (10) 999999, To be used only with DJO EMPOWR 3D KNEE
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-0921-2021·2021-02-03
OMNIlife Science Recalls SERF Novae Dual Mobility Cup Inserts
OMNIlife Science Inc. is recalling 3 units of SERF Novae Dual Mobility Cup Inserts due to high oxidation levels that may increase wear rates and require revision surgery.
Product
SERF Novae Dual Mobility Cup Insert 47/28- ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures. Product Code: H6-24728
Category
Medical Device
Distribution
5 states
SevereFDA (Devices)·Z-0922-2021·2021-02-03
OMNIlife Recalls SERF Novae Dual Mobility Cup Inserts Due to Oxidation
OMNIlife science Inc. is recalling 2 units of SERF Novae Dual Mobility Cup Inserts because they have higher than acceptable oxidation limits, which may increase wear rates and require revision surgery.
Product
SERF Novae Dual Mobility Cup Insert 49/28-ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures. Product Code: H6-24928
Category
Medical Device
Distribution
5 states
SevereFDA (Devices)·Z-0926-2021·2021-02-03
Medtronic COBALT HF QUAD CRT-D MRI SureScan Recall for Potential Loss of Function
Medtronic is recalling two specific COBALT HF QUAD CRT-D MRI SureScan devices due to a rare component failure mechanism that could cause loss of function.
Product
Medtronic COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, MR Conditional implantable cardioverter defibrillator with cardiac resynchronization therapy, SureScan technology, and Bluetooth wireless telemetry (DDE-DDDR)
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0903-2021·2021-02-03
Philips Respironics V60 Ventilator Recalled for Navigation Ring Defects
Respironics is recalling 9,856 V60 Ventilators worldwide due to navigation ring issues that may cause erratic parameter changes or inoperability.
Product
Philips Respironics V60 Ventilator Part Number 1053614 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0916-2021·2021-02-03
Philips Respironics V60 Ventilator Recall for Navigation Ring Defects
Respironics is recalling V60 ventilators because the navigation ring may fail or cause erratic parameter changes.
Product
Philips Respironics V60 Ventilator Part Number DU1053617 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories. Philips Respironics V60 Ventilator Part Number…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0904-2021·2021-02-03
Philips Respironics V60 Ventilator Recalled for Navigation Ring and Liquid Ingress Issues
Respironics is recalling 934 V60 Ventilators worldwide due to potential navigation ring malfunctions and liquid ingress risks.
Product
Philips Respironics V60 Ventilator Part Number 1053615 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0885-2021·2021-02-03
Philips Respironics V60 Ventilator Recalled for Backup Battery Failure Risk
Respironics is recalling 2,144 V60 Ventilators because the backup battery may fail if over-discharged or stored without AC power for extended periods.
Product
Philips Respironics V60 Ventilator Part Number 1053613 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0911-2021·2021-02-03
Philips Respironics V60 Ventilator Recalled for Navigation Ring Defect
Respironics is recalling 10,291 V60 ventilators worldwide due to a navigation ring that may fail or cause erratic parameter changes.
Product
Philips Respironics V60 Ventilator Part Number 1076716 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0935-2021·2021-02-03
Boston Scientific Recalls Emblem S-ICD Pulse Generators Due to Battery Depletion
Boston Scientific is recalling 7,093 Emblem S-ICD pulse generators because accelerated battery depletion may require earlier device replacement.
Product
EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0901-2021·2021-02-03
Philips Respironics V680 Ventilator Recalled for Backup Battery Failure Risk
Respironics is recalling 3,453 V680 Ventilators because the backup battery may fail if over-discharged or stored without AC power.
Product
Philips Respironics V680 Ventilator Part Number 850011 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0889-2021·2021-02-03
Philips Respironics V60 Ventilator Recall for Backup Battery Failure Risk
Respironics is recalling 46,313 V60 Ventilators worldwide due to a risk of backup battery failure if over-discharged or stored without AC power.
Product
Philips Respironics V60 Ventilator Part Number 1053617 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0905-2021·2021-02-03
Philips Respironics V60 Ventilator Recalled for Navigation Ring and Liquid Ingress Issues
Respironics is recalling V60 Ventilators because the navigation ring may malfunction or cause erratic parameter changes, and liquid may enter the device.
Product
Philips Respironics V60 Ventilator Part Number 1053616 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0928-2021·2021-02-03
Medtronic Cobalt DR MRI SureScan Defibrillators Recalled for Potential Loss of Function
Medtronic is recalling two specific MRI SureScan defibrillators because a component failure could cause the device to lose function.
Product
Medtronic Cobalt DR MRI SureScan DDPB3D1, MR Conditional implantable dual chamber cardioverter defibrillator with SureScan technology and Bluetooth wireless telemetry (DDE-DDDR)
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0909-2021·2021-02-03
Philips Respironics V60 Ventilator Recall for Navigation Ring Defects
Respironics is recalling three V60 ventilators because the navigation ring may malfunction or cause erratic parameter changes.
Product
Philips Respironics V60 Ventilator Part Number R1053618 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2113-2020·2021-02-03
Stryker Recalls Mislabeled Intracardiac Ultrasound Catheters Due to Expiration Date Error
Stryker is recalling 101 intracardiac ultrasound catheters labeled with incorrect expiration dates, posing risks of sterility breach or component breakdown.
Product
Cardiovascular Reprocessed ViewFlex Xtra ICE Catheter, REF D087031, OM St. Jude Medical, Size 9F (3.2mm), Length 90 cm, Sterile EO, Rx Only, Quantity 1, UDI: 07613327376067
Category
Medical Device
Distribution
16 states
HighFDA (Devices)·Z-0907-2021·2021-02-03
Philips Respironics V60 Ventilator Recalled for Navigation Ring Defects
Respironics is recalling 534 V60 Ventilators worldwide due to navigation ring malfunctions that may cause erratic parameter changes or inoperability.
Product
Philips Respironics V60 Ventilator Part Number 1053618 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0891-2021·2021-02-03
Philips Respironics V60 Ventilator Recall for Backup Battery Failure Risk
Respironics is recalling 3,752 V60 Ventilators worldwide due to a risk of backup battery failure if over-discharged or stored without AC power.
Product
Philips Respironics V60 Ventilator Part Number 1076709 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0919-2021·2021-02-03
Hardy Diagnostics Recalls Brain Heart Infusion Agar Plates Due to Contamination
Hardy Diagnostics is recalling specific lots of Brain Heart Infusion Agar plates because they failed to inhibit Staphylococcus aureus as required.
Product
Brain Heart Infusion Agar with 6 ug/ml Vancomycin Cat no: G14 Lot no: 472698 Manufactured: 2020-10-29 Expires: 2020-12-28 Container Type: 15x100mm plate, 18 ml
Category
Medical Device
Distribution
11 states
HighFDA (Devices)·Z-0927-2021·2021-02-03
Medtronic Cobalt HF CRT-D MRI SureScan Recall for Potential Loss of Function
Medtronic is recalling two specific Cobalt HF CRT-D MRI SureScan devices due to a rare failure mechanism that could cause loss of function.
Product
Medtronic Cobalt HF CRT-D MRI SureScan DTPB2D1, MR Conditional implantable cardioverter defibrillator with cardiac resynchronization therapy, SureScan technology, and Bluetooth wireless telemetry (DDE-DDDR)
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0894-2021·2021-02-03
Philips Respironics V60 Ventilator Recalled for Backup Battery Failure Risk
Respironics is recalling 10,441 V60 Ventilators because the backup battery may fail if over-discharged or stored without AC power for extended periods.
Product
Philips Respironics V60 Ventilator Part Number 1076716 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0888-2021·2021-02-03
Philips Respironics V60 Ventilator Recalled for Backup Battery Failure Risk
Respironics is recalling 330 V60 Ventilators because the backup battery may fail if over-discharged or stored without AC power for extended periods.
Product
Philips Respironics V60 Ventilator Part Number 1053616 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
Category
Medical Device
Distribution
Distributed nationwide

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12226–12250 of 27470