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

3201–3225 of 39824

ModerateFDA (Devices)·Z-2492-2025·2025-09-10
RayStation 11B software recalled over non-unique DICOM instance identifiers
RayStation 11B and its service packs are recalled because DICOM instance identifiers from the RayGateway interface to Accuray's iDMS are not guaranteed to be unique.
Product
RayStation with the following product descriptions: 1. RayStation 11B, Software Version: 12.0.0.932. 2. RayStation 11B Service Pack 1, Software Version: 12.1.0.1221. 3. RayStation 11B Service Pack 2, Software Version: 12.0.3.68. 4. RayStation 11B Service Pack 3, Soft
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2501-2025·2025-09-10
Uric acid monitoring kits recalled over missing premarket clearance or approval
A second lot group of Blood Uric Acid Monitoring System kits, model eB-U01, covering all lots made up to June 20, 2022, is recalled for distribution without premarket clearance. 2,580 units are affected.
Product
Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test strips (10-count bottle)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2488-2025·2025-09-10
RayStation 8B and 9A software recalled over DICOM identifier uniqueness defect
RayStation 8B, its service packs and 9A radiation therapy planning software is recalled because DICOM instance identifiers from the RayGateway interface are not guaranteed to be unique.
Product
RayStation with the following product descriptions: 1. RayStation 8B, Software Version: 8.1.0.47. 2. RayStation 8B Service Pack 1, Software Version: 8.1.1.8. 3. RayStation 8B Service Pack 2, Software Version: 8.1.2.5. 4. RayStation 9A, Software Version: 9.0.0.113.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2499-2025·2025-09-10
Defibrillator recalled because required post-service inspections were not performed
One LIFEPAK CR2 defibrillator is recalled because required inspections were not performed on units that had gone through servicing.
Product
LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451 99512-001434 883873785911 LIFEPAK CR2: The LIFEPAK CR2 defibrillator is indicated for use on patients 1 year of age or older in cardiopulmonary arrest. The patient must be unresponsive (unconscious), not breathin
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2504-2025·2025-09-10
Fluoroscopic X-ray systems recalled over air baffle missing from internal PCs
Philips Allura Xper interventional fluoroscopic X-ray systems are recalled because an air baffle component may be missing in some Nehalem FlexVision-2 PCs. 192 units are affected.
Product
Interventional Fluoroscopic X-Ray System - Philips Allura Xper Series. Labeled as the following with corresponding model numbers: 1. Allura Xper FD10, Model Number 722003. 2. Allura Xper FD10/10, Model Number 722005. 3. Allura Xper FD20, Model Number 722006. 4. All
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2493-2025·2025-09-10
RayStation 12A planning software recalled over duplicate DICOM instance identifier risk
RayStation 12A and its service packs are recalled because DICOM instance identifiers from the RayGateway interface to Accuray's iDMS are not guaranteed to be unique.
Product
RayStation with the following product descriptions: 1. RayStation 12A, Software Version: 13.0.0.1547. 2. RayStation 12A Service Pack 1, Software Version: 13.1.0.144. 3. RayStation 12A Service Pack 2, Software Version: 13.1.1.89. Product Description: Radiation Thera
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2495-2025·2025-09-10
RayStation 2023B and 2024A software recalled over non-unique DICOM identifiers
RayStation 2023B, 2024A and 2024A SP3 radiation therapy planning software is recalled because DICOM instance identifiers from the RayGateway interface are not guaranteed to be unique.
Product
RayStation with the following product descriptions: 1. RayStation 2023B, Software Version: 14.0.0.3338. 2. RayStation 2024A, Software Version: 15.0.0.430. 3. RayStation 2024A SP3, Software Version: 15.1.3.10. Product Description: Radiation Therapy Treatment Plannin
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2516-2025·2025-09-10
Spinal implant inserters recalled over potential missing pins at the tip
TOPS Inserters, model 82889, part of the TOPS System Instrument Set, are recalled because of the potential for missing pins at the tip of the inserter. 30 units are affected.
Product
TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Model Number: 82889.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2518-2025·2025-09-10
Hemodynamic recording systems recalled over pressure sensor error during blood pressure measurement
Merge Hemo systems are recalled because certain Schiller ARGUS PB-3000 patient data modules trigger a Pressure Sensor Defective error during non-invasive blood pressure measurement above 240 mmHg. 84 units are affected.
Product
Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions 11.1 and 11.1.1 Product Description: The Merge Hemo, Model RCSV2 device is a hemodynamics recording computer system that monitors, measures, displays, records and stores various physiologic and blood fl
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2489-2025·2025-09-10
RayStation 9B and 10A software recalled over non-unique DICOM identifiers
RayStation 9B, 9B SP1, 10A and 10A service pack radiation therapy planning software is recalled because DICOM instance identifiers from the RayGateway interface are not guaranteed to be unique.
Product
RayStation with the following product descriptions: 1. RayStation 9B, Software Version: 9.1.0.933. 2. RayStation 9B Service Pack 1, Software Version: 9.2.0.483. 3. RayStation 10A, Software Version: 10.0.0.1154. 4. RayStation 10A Service Pack 1, Software Version: 10.0
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2497-2025·2025-09-10
LIFEPAK 15 defibrillators recalled because post-service inspections were not performed
Four LIFEPAK 15 defibrillators are recalled because required inspections were not performed on units that had gone through servicing.
Product
LIFEPAK 15 Part / Catalog Numbers / UDI-DI code: V15-7-000022 / 99577-001957 / 883873871690 V15-2-000051 / 99577-000046 / 883873988022 V15-2-000099 / 99577-000093 / 883873979020 V15-2-001603 / 99577-001256 / 883873911631 LIFEPAK 15: The LP15 is intended for use by trained
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2514-2025·2025-09-10
Dental titanium bases recalled because the post is oriented 180 degrees off
NobelBiocare Tri-Lobe-compatible WP 6.0mm engaging titanium bases, lot 277097, are recalled because the base was manufactured 180 degrees around the post from the correct position. 11 units are affected.
Product
NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base, REF: 9000662
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2494-2025·2025-09-10
RayStation 6 service packs recalled over DICOM identifier uniqueness defect
RayStation 6 Service Packs 1, 2 and 3 radiation therapy planning software is recalled because DICOM instance identifiers from the RayGateway interface are not guaranteed to be unique.
Product
RayStation with the following product descriptions: 1. RayStation 6 Service Pack 1, Software Version: 6.1.1.2. 2. RayStation 6 Service Pack 2, Software Version: 6.2.0.7. 3. RayStation 6 Service Pack 3, Software Version: 6.3.0.6. Product Description: Radiation Thera
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2517-2025·2025-09-10
Flowmeter patches recalled over expiry date printed one year too early
FloPatch FP120 flowmeter patches, lot 03250602, are recalled because the human readable expiry date on the outer shipping packaging reads 2025-06-20 when it should read 2026-06-20. 9 units are affected.
Product
FloPatch FP120, REF: FP120-FOT01-005
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2460-2025·2025-09-03
Reprocessed electrophysiology catheters recalled over small residual particulates in specific lots
Medline ReNewal reprocessed St. Jude Medical diagnostic electrophysiology catheters are recalled because specific lots may contain small residual particulates. The FDA classified the action as Class I.
Product
Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic Electrophysiology Catheter Models 401150RH, 401206RH, 401207RH, 401210RH, 401211RH, 401212RH, 401222RH, 401223RH, 401226RH, 401227RH, 401228RH, 401260RH, 401261RH, 401271RH, 401305RH, 401306RH, 401309RH
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2343-2025·2025-09-03
Insulin pumps recalled over malfunction that stops insulin delivery and alerts
Tandem t:slim X2 insulin pumps built with Revision A and B speakers may hit Malfunction 16, losing audible alerts and stopping insulin delivery. The FDA classified the action as Class I. 171,750 units are affected.
Product
Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; t:slim X2 GS Classic, Replacement, Refurbished, REF: 1003808; t: slim X2, Basal-IQ, mg/dl, REF: 1004219; Pump, t:slim X2, Clinical Use Only, REF: 1004484; Pump, t:slim X2, Control-IQ, REF:
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2467-2025·2025-09-03
Perfusion and laparoscopy packs recalled over unjustified sterilization of certain components
American Contract Systems supplement, kidney perfusion and lapchol/appy packs are recalled because the firm cannot confirm that product sterilization assurance requirements were met. 6,617 units are affected.
Product
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) A-C SUPPLEMENT PACK - 205946, Model/Item Number ANCV67X; 2) KIDNEY PERFUSION PACK - 208439, Model/Item Number ANKP15AD; 3) LAPCHOLAPPY PACK, Model/Item Number FYLA38G; 4) CYSTO PACK, Model/Item N
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2451-2025·2025-09-03
Intraocular lenses recalled after off-power error produced wrong diopter strength
Two Akreos intraocular lenses from lot 1Q29212 are recalled after an off-power error produced a 16 diopter lens rather than the intended 3 diopter.
Product
Akreos, SKU: AO60P0300. Akreos intraocular lenses
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2444-2025·2025-09-03
Loupe nose pad kits recalled because nickel content may cause allergic reaction
Orascoptic Dragonfly Nose Pad Accessory Kits are recalled because loupe nose pads containing nickel may cause an allergic reaction, following complaints. 743 kits are affected.
Product
Orascoptic Superior Visualization Dragonfly Nose Pad Accessory Kit ( nose pad and screw) 1 pk and 20 pk.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2464-2025·2025-09-03
Heart and vascular packs recalled because sterilization rationale was not justified
American Contract Systems heart, vascular and off-pump CABG packs are recalled because the firm cannot confirm that product sterilization assurance requirements were met. 31,506 units are affected.
Product
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) HEART PACK - 205947, MODEL/ITEM NUMBER ANCV78BC; 2) VASCULAR PACK - 232024, MODEL/ITEM NUMBER ANVA82AB; 3) OFF PUMP CABG PACK - 170316, MODEL/ITEM NUMBER BHOP48O; 4) OFF PUMP CABG PACK - 170316, M
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2442-2025·2025-09-03
Dragonfly Essentials loupe kits recalled because nickel nose pads may cause allergy
Orascoptic Dragonfly Essentials Kits are recalled because loupe nose pads containing nickel may cause an allergic reaction, following complaints. 32 kits are affected.
Product
Orascoptic Superior Visualization Dragonfly Essentials Kit ( Nose pad, a screw, lens cleaning wipe, side shields, head strap, and a screwdriver)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2445-2025·2025-09-03
Phantom nose pad kits recalled because nickel content may cause allergic reaction
Orascoptic Phantom Nose Pad Accessory Kits are recalled because loupe nose pads containing nickel may cause an allergic reaction, following complaints. 22 kits are affected.
Product
Orascoptic Superior Visualization Phantom Nose Pad Accessory Kit ( nose pad and screw) 1 pk. and 20 pk.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2341-2025·2025-09-03
OEC 9800 C-arm systems recalled over missing collimator cover lead tape
GE HealthCare OEC 9800 C-arm systems are recalled because impacted units are missing the full layer of lead tape in the collimator covers, slightly increasing radiation exposure.
Product
GE HealthCare OEC 9800.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2469-2025·2025-09-03
Labor and delivery packs recalled over unconfirmed product sterilization assurance
American Contract Systems Born on Arrival kits and Labor & Delivery packs are recalled because the firm cannot confirm that product sterilization assurance requirements were met. 781 units are affected.
Product
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) BORN ON ARRIVAL KIT, Model/Item Number LLBN11C; 2) LABOR & DELIVERY PACK, Model/Item Number LLLD19I.
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2443-2025·2025-09-03
Phantom Essential loupe kits recalled because nickel nose pads may cause allergy
Orascoptic Phantom Essential Kits are recalled because loupe nose pads containing nickel may cause an allergic reaction, following complaints. 74 kits are affected.
Product
Orascoptic Superior Visualization Phantom Essential kit ( Nose pad, a screw, lens cleaning wipe, side shields, head strap, and a screwdriver)
Category
Medical Device
Distribution
Distributed nationwide

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3201–3225 of 39824