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

2376–2400 of 27375

HighFDA (Devices)·Z-2221-2025·2025-08-06
Volcano Visions IVUS catheters can entangle with the guide wire
Volcano Visions Digital IVUS Catheters are being recalled following reports of catheter and guide wire entanglement during radial-to-peripheral procedures, which may require surgical removal. 233,817 units affected.
Product
Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P; PV.014P RX, REF: 014R; and PV.018, REF: 86700, 86700J used with Instructions for use.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2225-2025·2025-08-06
Blood EMB Levine plates may carry Listeria monocytogenes contamination
Blood/EMB Levine plates, product number R02041, are being recalled because the products may contain surface and subsurface contamination of Listeria monocytogenes. 750 units are affected.
Product
Blood/EMB, Levine 100/PK, Product Number R02041
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2174-2025·2025-08-06
HeartSine samaritan public access defibrillators may not deliver shocks properly
HeartSine SAM 350P, 360P and 450P public access defibrillators are being recalled because a component manufacturing issue means the device may not function properly to deliver shocks. 190,516 units affected.
Product
HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan¿ PAD (Public Access Defibrillator)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2206-2025·2025-08-06
Philips Ingenia 3.0T gradient coils may act as a heat source
Ingenia 3.0T MR systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 1,467 units are affected.
Product
Ingenia 3.0T Model Numbers (REF): (1) 781342, (2) 781377, (3) 782103;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2218-2025·2025-08-06
Philips MR 7700 upgrade gradient coils may act as a heat source
Upgrade to MR 7700 systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 26 units are affected.
Product
Upgrade to MR 7700 Model Number (REF): 782130;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2222-2025·2025-08-06
Osteotec silicone finger implants may contain foreign material
Osteotec Silicone Finger Implants in sizes 3, 4 and 5 are being recalled because there is the potential that the silicone implant may contain foreign material. 15,573 units are affected.
Product
Brand Name: Osteotec Product Name: Osteotec Silicone Finger Implant Model/Catalog Number: OSTF-3 (Sz. 3), OSTF-4 (Sz. 4), OSTF-5 (Sz. 5) Software Version: N/A Product Description: The Osteotec Silicone Finger Implant is a one-piece, sterile, flexible silicone elastomer implan
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2213-2025·2025-08-06
Philips MR 5300 gradient coils may act as a heat source
MR 5300 systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 551 units are affected.
Product
MR 5300 Model Numbers (REF): (1) 782110, (2) 782135 (China ONLY), (3) 782152;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2220-2025·2025-08-06
Celsior cold storage solution recalled over sterility assurance during aseptic manufacturing
Celsior Cold Storage Solution is being recalled because of the potential risk of microbiological contamination due to an inability to ensure sterility assurance throughout aseptic manufacturing. 1,532 units affected.
Product
Brand Name: Celsior Cold Storage Solution Product Name: Celsior Cold Storage Solution Model/Catalog Number: 533682 Product Description: In US Celsior is a class II medical device. Celsior is a clear to slightly yellow, sterile, non pyrogenic solution for hypothermic flushing
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2230-2025·2025-08-06
RAPIDPoint 500 wash waste cartridge lot biases seven blood analytes
A lot of RAPIDPoint 500 Systems Wash/Waste Cartridges is being recalled because a manufacturing error causes positive and negative bias across seven analytes. 1,477 units are affected.
Product
RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2199-2025·2025-08-06
SwabFlush prefilled syringes carry SwabCaps with a compromised seal
SwabFlush Prefilled Syringes with ICU Medical SwabCaps are being recalled because a manufacturing issue affects the SwabCap seal, which may reduce disinfection of the luer access valve. 1,427,100 units affected.
Product
SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE010301
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2217-2025·2025-08-06
SmartPath to Ingenia Elition X gradient coils may overheat
SmartPath to Ingenia Elition X systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 33 units affected.
Product
SmartPath to Ingenia Elition X Model Numbers (REF): (1) 782118, (2) 782144;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2201-2025·2025-08-06
Philips Achieva XR gradient coils may act as a heat source
Achieva XR MR systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 40 units are affected.
Product
Achieva XR; Model Numbers (REF): (1) 781153, (2) 781253;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2209-2025·2025-08-06
Philips Ingenia Ambition X gradient coils may act as heat source
Ingenia Ambition X MR systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 690 units are affected.
Product
Ingenia Ambition X Model Numbers (REF): (1) 781356, (2) 782109, (3) 782138;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2210-2025·2025-08-06
Philips Ingenia Elition S gradient coils may act as a heat source
Ingenia Elition S MR systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 242 units are affected.
Product
Ingenia Elition S Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (4) 782150 (China ONLY);
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2203-2025·2025-08-06
Philips Evolution Upgrade 3.0T gradient coils may act as heat source
Evolution Upgrade 3.0T MR systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 50 units are affected.
Product
Evolution Upgrade 3.0T Model Numbers (REF): (1) 782117, (2) 782143;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2198-2025·2025-08-06
CoSense sampling sets may carry residual carbon monoxide from insufficient aeration
Precision Sampling Sets for the CoSense End-Tidal Carbon Monoxide Monitor are being recalled because residual carbon monoxide may remain in the cannula filter, which may raise ETCOc scores. 2,160 units affected.
Product
Precision Sampling Set, REF: C20206 for use with the CoSense End-Tidal Carbon Monoxide Monitor
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2202-2025·2025-08-06
Philips Evolution Upgrade 1.5T gradient coils may act as a heat source
Evolution Upgrade 1.5T MR systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 93 units are affected.
Product
Evolution Upgrade 1.5T Model Numbers (REF): (1) 782116, (2) 782148;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2215-2025·2025-08-06
SmartPath to dStream 3.0T gradient coils may act as heat source
SmartPath to dStream for 3.0T systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 15 units affected.
Product
SmartPath to dStream for 3.0T Model Number (REF): 782145;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2211-2025·2025-08-06
Philips Ingenia Elition X gradient coils may act as heat source
Ingenia Elition X MR systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 632 units are affected.
Product
Ingenia Elition X Model Numbers (REF): (1) 781358, (2) 782107, (3) 782119, (4) 782136, (5) 782151 (China ONLY);
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2235-2025·2025-08-06
LVP dual Y-site administration sets have potential for external cassette leaks
LVP Primary Administration Sets, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site, are being recalled because of the potential for external cassette leaks. 348,150 units are affected.
Product
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Product Code: SET-0032-25.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2205-2025·2025-08-06
Philips Ingenia 1.5T S gradient coils may act as heat source
Ingenia 1.5T S MR systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 136 units are affected.
Product
Ingenia 1.5T S Model Number (REF): 781347;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2178-2025·2025-08-06
HarmonyAIR E-Series monitor yokes may detach from the spring arm
Dual Flat Panel Monitor accessories for HarmonyAIR E-Series Surgical Lighting Systems are being recalled because the yoke assembly may detach from the spring arm. 59 units are affected.
Product
Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2223-2025·2025-08-06
Blood agar plates may carry Listeria monocytogenes surface contamination
Blood Agar with 5% Sheep Blood, product number R01202, is being recalled because the products may contain surface and subsurface contamination of Listeria monocytogenes. 1,552 units affected.
Product
Blood Agar,5% Sheep Blood 100/PK, Product Number R01202
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2177-2025·2025-08-06
HarmonyAIR dual flat panel monitor yokes may detach from spring arm
Dual Flat Panel Monitor accessories for HarmonyAIR A-Series Surgical Lighting Systems are being recalled because the yoke assembly may detach from the spring arm. 167 units are affected.
Product
Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical Lighting Systems
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2138-2025·2025-07-30
Natus brain monitor breakout box shows right side impedance under left
The Natus Brain Monitor Breakout Box is being recalled after two complaints that the left side labeling showed impedance for the right side. 27 units are affected.
Product
Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalograph
Category
Medical Device
Distribution
7 states

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