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

15276–15300 of 39988

HighFDA (Devices)·Z-0899-2021·2021-02-03
Philips Respironics V60 Ventilator Recalled for Backup Battery Failure Risk
Respironics is recalling 481 V60 Ventilators due to potential backup battery failures caused by over-discharge or extended storage without AC power.
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.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0890-2021·2021-02-03
Philips Respironics V60 Ventilator Recalled for Backup Battery Failure Risk
Respironics is recalling 534 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 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-0913-2021·2021-02-03
Philips Respironics V60 Plus Ventilator Recall Due to Navigation Ring Malfunction
The FDA is recalling the Philips Respironics V60 Plus Ventilator because its navigation ring may become inoperative or operate intermittently, potentially causing ventilator parameter values to change erratically during setup or adjustment.
Product
Philips Respironics V60 Plus Ventilator Part Number 1137276 - 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-0898-2021·2021-02-03
Philips Respironics V60 Plus Ventilator Recalled for Battery Failure Risk
Respironics is recalling 702 V60 Plus Ventilators worldwide because the backup battery may fail if over-discharged or stored without AC power.
Product
Philips Respironics V60 Plus Ventilator Part Number 1138747 - 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-0912-2021·2021-02-03
Philips Respironics V60 Ventilator Recalled for Navigation Ring Defects
Respironics is recalling 216 V60 Ventilators because the navigation ring may fail or cause erratic parameter changes.
Product
Philips Respironics V60 Ventilator Part Number 1076717 - 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-0902-2021·2021-02-03
Philips Respironics V60 Ventilator Recalled for Navigation Ring Defects
Respironics is recalling 2,137 V60 Ventilators because the navigation ring may malfunction or cause erratic parameter changes.
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-0917-2021·2021-02-03
Philips Respironics V680 Ventilator Recalled for Navigation Ring Defects
Respironics is recalling 3,453 V680 ventilators worldwide because the navigation ring may fail or cause erratic parameter changes.
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-0893-2021·2021-02-03
Philips Respironics V60 Ventilator Recalled for Backup Battery Failure Risk
Respironics is recalling 3,213 V60 Ventilators because the backup battery may fail if over-discharged or stored without AC power.
Product
Philips Respironics V60 Ventilator Part Number R1076709 - 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-0908-2021·2021-02-03
Philips Respironics V60 Ventilator Recall for Navigation Ring Issues
Respironics is recalling 3,752 V60 Ventilators worldwide due to potential navigation ring malfunctions that may cause erratic parameter changes or inoperability.
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-1766-2020·2021-02-03
Philips Telemetry Transceiver Recall for Heart Rate Display Failure
Philips is recalling 21,672 telemetry transceivers because they may fail to display heart rates or generate alarms when used with specific Patient Information Center software.
Product
TRx4851A 2.4 GHz IntelliVue Tele TRX, Model Number 862231; Includes Service Numbers 453564052401, 453564052411, 453564052441, 453564052451, 453564166851, 453564166861
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0929-2021·2021-02-03
Neocis Anterior Chairside Splints Recalled for Potential Mislabeling
Neocis, Inc. is recalling 100 units of Gen 2 Anterior Chairside Splints due to potential mislabeling. The affected units were distributed to facilities in seven states.
Product
DRW-0739-01:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left); accessories to the parent system, the Neocis Guidance System (NGS)
Category
Medical Device
Distribution
7 states
ModerateFDA (Devices)·Z-0923-2021·2021-02-03
BD Stimex Insulated Needle Recall for Missing Contraindications
Becton Dickinson is recalling BD Stimex Insulated Needles because the instructions for use lack general contraindications.
Product
BD Stimex Insulated Needle 22G x 2.13in ( 50 units/cs.) Indicated for administration of medications to affect anesthesia or analgesia to a specific anatomical location (region). Catalog No. 404204
Category
Medical Device
Distribution
18 states
ModerateFDA (Devices)·Z-0918-2021·2021-02-03
Fujifilm Synapse PACS Software Recalled for Clinical Reporting Errors
Fujifilm Medical Systems is recalling Synapse PACS Software versions 7.0.0 and 7.0.1 because the software fails to update measurements when ventricular traces are changed by different users.
Product
FUJIFILM Synapse PACS Software: versions 7.0.0 and 7.0.1 - Product Usage: intended for use as a web based application on an off-the shelf PC which meets or exceeds minimum specifications and is networked with a FUJIFILM Synapse PACS server.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0930-2021·2021-02-03
B. Braun Introcan IV Safety Catheters Recalled for Lack of FDA Approval
Braxton Medical Corporation is recalling B. Braun Introcan IV Safety Catheters because the products do not have FDA approval for sale in the United States.
Product
B. Braun Introcan IV Safety Catheters, sterile - Product Usage: It is a single-use device to generate intravascular and tissue access to sample blood, monitor blood pressure, or administer fluids and blood intravascular.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0924-2021·2021-02-03
BD Regional Block Needles Recalled for Missing Contraindications in Instructions
Becton Dickinson is recalling BD Regional Block Needles because the instructions for use lack general contraindications, as advised by the European Notified Body.
Product
BD Regional Block Needles 22G x 1.50in (50 units/cs.). Indicated for administration of medications to affect anesthesia or analgesia to a specific anatomical location (region). Catalog No. 408348
Category
Medical Device
Distribution
18 states
ModerateFDA (Devices)·Z-0865-2021·2021-02-03
Nihon Kohden PSG-1100 Sleep Diagnostic System Recalled for Electrical Safety Non-Conformance
Nihon Kohden America Inc is recalling 189 PSG-1100 Sleep Diagnostic Systems because they do not meet the IEC 60601-1 electrical safety standard.
Product
PSG-1100 Sleep Diagnostic System. Sample product label: JB-110A SERIAL No. 01454 RoHS Compliant; PSG-100 Head Box; UDI (01) 04931921108383; Made in Japan The PSG-1100 Sleep Diagnostic System is a digital PSG amplifier intended to record the electrical activity of the brain…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0932-2021·2021-02-03
Fujifilm Recalls Wako HDL-C/LDL-C Calibrator Due to Labeling Error
Fujifilm is recalling Wako HDL-C/LDL-C Calibrator Lot EL629 because incorrect concentration values were printed on the bottle labels, which may result in incorrect testing results.
Product
Wako HDL-C/LDL-C Calibrator - Product Usage: designed to be used with Wako L-Type HDL-C or L-Type LDL-C for the determination of high density lipoprotein cholesterol (HDL-C) or low density lipoprotein cholesterol (LDL-C) in serum or plasma.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0727-2021·2021-02-03
Philips ProxiDiagnost N90 X-ray System Recalled for Software Lock-in Defect
Philips is recalling 91 ProxiDiagnost N90 X-ray systems because kV and mA values may not lock correctly after a command, potentially affecting image quality.
Product
ProxiDiagnost N90 Image-intensified fluoroscopic x-ray system
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0931-2021·2021-02-03
Yukon polyaxial screw component recalled for incorrect laser marking
The Yukon polyaxial screw component in the Yukon Spinal System was recalled because it was incorrectly laser marked with wrong dimensions.
Product
Yukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component of YUKON Spinal System
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0879-2021·2021-01-27
Boston Scientific Recalls Emblem S-ICD Subcutaneous Electrodes Due to Fracture Risk
Boston Scientific is recalling Emblem S-ICD Subcutaneous Electrodes because fractures may prevent the device from delivering therapy.
Product
EMBLEM S-ICD Subcutaneous Electrode Model 3501. Component of implantable cardioverter defibrillator (ICD)
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-0848-2021·2021-01-27
Penumbra JET 7 Reperfusion Catheter Recalled for Potential Tip Damage
Penumbra Inc. is recalling 3,368 JET 7 Reperfusion Catheters because the distal tip may become damaged during use, posing a risk of vessel damage and patient injury or death.
Product
Penumbra JET 7 Reperfusion Catheter REF 5MAXJET7 The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) is a component of the Penumbra system. JET 7 Xtra Flex delivers aspiration from the Aspiration Pump to the site of occlusion to assist in the…
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0849-2021·2021-01-27
Penumbra JET 7 Reperfusion Catheter Recalled for Potential Vessel Damage
Penumbra Inc. is recalling JET 7 Reperfusion Catheters because distal tip damage could cause vessel injury or death during use.
Product
Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF 5MAXJET7KIT The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) is a component of the Penumbra system. JET 7 Xtra Flex delivers aspiration from the Aspiration Pump…
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0850-2021·2021-01-27
Penumbra JET 7 Reperfusion Catheter Recalled for Potential Tip Damage
Penumbra Inc. is recalling JET 7 Reperfusion Catheters because distal tip damage could cause vessel injury or death during use.
Product
Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF 5MAXJET7L138KIT The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) is a component of the Penumbra system. JET 7 Xtra Flex delivers aspiration from the Aspiration…
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0851-2021·2021-01-27
Penumbra JET 7MAX Kits Recalled for Potential Vessel Damage Risk
Penumbra Inc. is recalling JET 7MAX Kits because catheter tip damage during use could cause vessel damage, leading to patient injury or death.
Product
Penumbra JET 7MAX KIT Penumbra JET 7 Reperfusion Catheter+ MAX Delivery Device + Hi-Flow Aspiration Tubing REF J7XKIT132 The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) is a component of the Penumbra system. JET 7 Xtra Flex delivers…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0876-2021·2021-01-27
Steris Reliance Vision Washer/Disinfector Recalled for Fire Risk
Steris is recalling Reliance Vision Single-Chamber Washer/Disinfector units because a faulty electrical contactor may cause the drying chamber to overheat, potentially leading to smoke or fire.
Product
Reliance Vision Single-Chamber Washer/Disinfector - Product Usage: intended for use in the cleaning and intermediate level disinfection of soiled reusable utensils, trays, glassware, bedpans and urinals, rubber and plastic goods, simple hard-surfaced rigid surgical instruments…
Category
Medical Device
Distribution
Distributed nationwide

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15276–15300 of 39988