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

4001–4025 of 39824

ModerateFDA (Devices)·Z-1687-2025·2025-05-07
Boston Scientific IceSeed CX Cryoablation Needles Incorrectly Programmed
Boston Scientific is recalling IceSeed 1.5 CX S cryoablation needles manufactured April 2024 to February 2025 that were programmed with DEMO instead of Commercial settings. If disconnected and reconnected after initial testing, the system will re-prompt testing rather than functioning normally.
Product
IceSeed 1.5 CX S NEEDLE OUS, Cryoablation Needle, REF H7493967334100. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1706-2025·2025-05-07
Medline Sterile 0.9% Normal Saline 100mL bottles recalled for leaks
Medline Sterile 0.9% Normal Saline 100mL bottles are being recalled because they may leak at the interface where the peel-foil meets the bottle opening. The bottles were distributed nationwide in the US and in Panama and Canada.
Product
Medline Sterile 0.9% Normal Saline, USP, 100mL, REF RDI30296
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1710-2025·2025-05-07
Medline Plastics Suture Tray recalled due to leaking sterile liquid bottles
Medline is recalling Plastics Suture Tray kits (Ref SUT13535) because the included Sterile Water and Sterile 0.9% Normal Saline bottles leak at the peel-foil and bottle opening interface.
Product
Medline procedure kits, labeled as: PLASTICS SUTURE TRAY, REF SUT13535
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1686-2025·2025-05-07
IceSeed 1.5 CX S Cryoablation Needle Programmed with Incorrect Settings
Boston Scientific is recalling 435 IceSeed 1.5 CX S cryoablation needles manufactured between April 2024 and February 2025 that were programmed with DEMO settings instead of Commercial settings, which can cause the Cryoablation System to prompt repeated tests if the needle is disconnected and reconnected.
Product
IceSeed 1.5 CX S NEEDLE US, Cryoablation Needle, REF H7493967233100. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1691-2025·2025-05-07
Automated External Defibrillators DDU-2200 Missing Italian Language Translation
Defibtech is recalling Automated External Defibrillators Model DDU-2200 distributed in Switzerland because they lack required Italian language labeling and instructions for use.
Product
Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1¿(German/English dual language), DCF-E2210-F3/1¿(French/English dual language)
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-1694-2025·2025-05-07
Defibtech Automated External Defibrillators Model DDU-2200 Missing Italian Translation
Defibtech is recalling Automated External Defibrillators Model DDU-2200 distributed in Switzerland due to missing Italian translation of product labeling and instructions, which violates Swiss Medical Devices Ordinance requirements.
Product
Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1¿(German/English dual language), DCF-E2210-F3/1¿(French/English dual language)
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-1690-2025·2025-05-07
Semi-Automated External Defibrillators Missing Italian Language Labeling
Defibtech is recalling semi-automated external defibrillators (Models DDU-100 and DDU-100E) distributed in Switzerland because they lack required Italian language labeling and instructions for use.
Product
Semi-Automated External Defibrillators; Models: DDU-100 and DDU-100E. Item numbers: DCF-E110SG-DE/1 (German language), DCF-E110SG-FR/1 (French language), DCF-E110SG-IT/1 (Italian language)
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1644-2025·2025-04-30
Amplatzer TorqVue LP Catheter Recalled for Shaft Breach Risk
Abbott is recalling the Amplatzer TorqVue LP Catheter (Model 9-TVLPC4F90/080) due to a potential small breach in the proximal shaft that may not be visible and could lead to prolonged procedures, blood loss, or air embolism.
Product
Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1643-2025·2025-04-30
Amplatzer TorqVue LP Delivery System Recall for Shaft Breach
Abbott is recalling specific lots of the Amplatzer TorqVue LP Delivery System due to a possible small breach in the shaft that is not visible but could lead to prolonged procedures, blood loss, or air embolism.
Product
Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1585-2025·2025-04-30
Novasight Hybrid Catheter Recalled for Potential Sheath Detachment
Conavi Medical Inc. is recalling the Novasight Hybrid Catheter (Model TA-06-0001) due to manufacturing issues that could cause the catheter sheath to detach. The device is used for diagnostic intravascular imaging.
Product
Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid Catheter Model/Catalog Number: TA-06-0001 Product Description: Common Name: Diagnostic intravascular catheter Description: The Novasight Hybrid catheter is a 3Fr single use, sterile device, which will be able
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-1654-2025·2025-04-30
Abbott CELL-DYN Ruby hematology analyzer affected by expired reagent date masking
Abbott is recalling the CELL-DYN Ruby hematology analyzer because expired reagents may have their expiration dates automatically changed to current or future dates without user notification, potentially leading to use of expired reagents.
Product
Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-10 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1639-2025·2025-04-30
BD PYXIS MEDBANK Automated Dispensing Cabinet Software Defect
CareFusion's BD PYXIS MEDBANK and MEDFLEX automated dispensing cabinets may experience a software issue during bin restocking that doubles bin quantities, potentially delaying access to medications and supplies.
Product
BD PYXIS MEDBANK (Name, REF): MEDPASS MODULE, 139088-01; MINI 1FH-1FM, 169-137; MINI 1HH-1FH-1HM, 169-101; MINI 1HH-1HM-1FM, 169-102; MINI 2FH, 138902-01; MINI 2FH, 169-104; MINI 2FM, 169-105; MINI 2HH-1FH, 169-106; MINI 2HH-1FH, 138908-01; MINI 2HH-1FM, 169-107; MINI
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1655-2025·2025-04-30
CELL-DYN Ruby hematology analyzer system expiration date validation
Abbott Laboratories is recalling CELL-DYN Ruby hematology analyzers (model 08H67-13) because expired reagents can be used without proper notification when their expiration dates are scanned or entered into the system.
Product
Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-13 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1656-2025·2025-04-30
CELL-DYN Ruby hematology analyzer medical device recall
Abbott Laboratories is recalling CELL-DYN Ruby hematology analyzers because expired reagents may be used without user notification when scanned or manually entered into the system, contrary to manufacturer guidelines.
Product
Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 04U42-84 Software Version: All software versions Product Description: CELL-DYN Ruby
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1652-2025·2025-04-30
CELL-DYN Ruby Hematology Analyzer Expiration Date Software Defect
Abbott's CELL-DYN Ruby hematology analyzer may accept expired reagents without alerting the operator, potentially allowing use of expired materials in patient testing.
Product
Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-01 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1623-2025·2025-04-30
Medtronic NIM Vital Nerve Monitoring System Software Version Recall
Medtronic is recalling NIM Vital Nerve Monitoring Systems with software versions v1.6.4 or earlier due to potential increased stimulus artifact that may require troubleshooting and could lead to procedure delay, extubation, and medical intervention.
Product
NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01; CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED, REF: NIM4CM01RF; PATIENT INTERFACE NIM4CPB1 NIM 4.0, REF: NIM4CPB1; PATIENT INTFC NIM4CPB1RF NIM 4.0 REFURB, REF: NIM4CPB1RF; SOFTWARE NIM4SWU143 UPGRA
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1650-2025·2025-04-30
InPen Smart Insulin Pen Recall Due to Incorrect Assembly
Medtronic MiniMed is recalling InPen smart insulin pens that may have been incorrectly assembled, potentially causing the insulin cartridge to not fit or the cartridge holder to be difficult to remove. Users without backup insulin could experience temporary hyperglycemia.
Product
InPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MMT-105ELBLNA, MMT-105ELGYNA, MMT105ELPKNA
Category
Medical Device
Distribution
41 states
HighFDA (Devices)·Z-1583-2025·2025-04-30
Zenition 70 Medical Device Recall: Unintended Radiation Exposure Risk
Philips is recalling Zenition 70 systems with Vascular Extension option and Wireless Foot Switch due to potential for unintended radiation exposure in healthcare facilities.
Product
Zenition 70. The device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-sterile environment in a variety of procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1581-2025·2025-04-30
Zenition 70 Radiological System Wireless Foot Switch Recall
Philips is recalling Zenition 70 radiological systems with wireless foot switches that may stick in the active position when released, potentially causing unintended radiation emission during medical procedures.
Product
Zenition 70. Product Code 718133. The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the devices.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1622-2025·2025-04-30
VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System C-Ring Break
Maquet Cardiovascular is recalling the VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System due to a ceramic C-Ring component that may break during use. At least 12 user complaints were reported as of March 3, 2025.
Product
The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm extended length endoscope. The Harvesting Cannula has four lumens which house the endoscope, C-Ring, distal lens washer tube, and Harvesting Tool for cutting and cauterizin
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1660-2025·2025-04-30
Philips Brilliance CT Big Bore X-Ray System Gantry Motion Collision Hazard
Philips is recalling Brilliance CT Big Bore computed tomography systems due to unintended motion in the interventional control that may cause the gantry or table to collide with operators or patients.
Product
Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1580-2025·2025-04-30
Zenition 50 Medical Imaging Devices Wireless Foot Switch Recall
Philips is recalling Zenition 50 medical imaging devices because the wireless foot switch pedal may get stuck in the active position, causing unintended radiation emission.
Product
Zenition 50. Product Code 718096. The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the devices.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1670-2025·2025-04-30
Rover Mobile X-ray System internal fastening mechanism failure risk
Micro-X Ltd. is recalling the Rover Mobile X-ray System (model MXU-RV35) due to a potential failure of the internal fastening mechanism within the generator. Five units distributed in New Jersey, Washington, and Puerto Rico are affected.
Product
Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number:MXU-RV35 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring medical diagno
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-1669-2025·2025-04-30
Rover Mobile X-ray System internal fastening mechanism failure potential
Micro-X Ltd. is recalling Rover Mobile X-ray System units (models MXU-RV71, MXU-RV35) due to a potential failure of the internal fastening mechanism within the generator. Affected units were distributed in New Jersey, Washington, and Puerto Rico.
Product
Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71, MXU-RV35 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring med
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-1663-2025·2025-04-30
Skytron Freedom Monitor Mount Hardware Recall for Inadequate Thread Engagement
The mounting hardware supplied with the Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount does not provide adequate thread engagement to support the weight of the frame and monitor, creating a risk of hardware failure and separation.
Product
Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount
Category
Medical Device
Distribution
Distributed nationwide

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4001–4025 of 39824