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

101–125 of 40397

ModerateFDA (Devices)·Z-0089-2027·2026-10-14
Nihon Kohden CNS-6200 Central Nurse Station Recalled for Cybersecurity Vulnerability
Nihon Kohden America LLC is recalling 808 CNS-6200 Series Central Nurse Stations due to a cybersecurity vulnerability that could disrupt patient monitoring.
Product
Product Name: Nihon Kohden CNS-6200 Series Central Nurse Station, Model/Catalog Number: CN-6201 Software Version: software versions: 01-03, 01-04, 01-05, 01-06, 02-10, 02-11, and 02-40 Product Description: The device is intended for use by medical professionals to provide…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0115-2027·2026-10-14
Mindray cPM Series Patient Monitor Manuals Recalled for Alarm Clarification
Mindray DS USA, Inc. is recalling cPM Series Patient Monitor operator's manuals because descriptions of physiological alarm functions may be insufficient or require clarification.
Product
cPM Series Patient Monitor. Operator's Manual: cPM 8/cPM 12
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0069-2027·2026-10-14
Medical Action Industries Recalls Urine Clean Catch Kits Due to Labeling Error
Medical Action Industries is recalling Urinary Clean Catch kits due to an internal data-entry error that resulted in an incorrect expiration date on the label.
Product
Generic Name: Kit, Urine, Clean Catch Trade Name: Kit: Urinary Clean Catch 20/cs Model/Catalog Number: 76769 Lot Number: 333606 UDI-DI: 20809160118228 Software Version: N/A
Category
Medical Device
Distribution
1 state
LowFDA (Devices)·Z-0114-2027·2026-10-14
Mindray Recalls Passport Series Patient Monitor Operator's Manuals
Mindray DS USA, Inc. is recalling Passport Series Patient Monitor operator's manuals because descriptions of selected physiological alarm functions may be insufficient or require clarification.
Product
Passport Series Patient Monitor. Operator's Manuals: 8 / 12 / 12M / 17M / V
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0109-2027·2026-10-14
Mindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
Mindray DS USA is recalling ePM Series Patient Monitor operator's manuals because descriptions of physiological alarm functions may be insufficient or require clarification.
Product
ePM Series Patient Monitor. Patient Monitor Series: ePM 10M/ePM 12M/ePM 12MA/ ePM 15M/ePM 10A
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0113-2027·2026-10-14
Mindray Recalls BeneView T5 and T8 Operator's Manuals for Alarm Clarification
Mindray DS USA, Inc. is recalling 133 BeneView T5 and T8 operator's manuals because descriptions of physiological alarm functions may be insufficient or require clarification.
Product
BeneView Series. Operator's Manuals: T5 / T8
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0112-2027·2026-10-14
Mindray Panorama and Telemetry Monitoring System Operator's Manuals Recalled
Mindray DS USA, Inc. is recalling Panorama and Telemetry Monitoring System operator's manuals because descriptions of selected physiological alarm functions may be insufficient or require clarification.
Product
Panorama and Telemetry Monitoring System. Operator's Manuals: TMS-6016/Panorama Telepack-608/TMS60 (TD60).
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0110-2027·2026-10-14
Certain Mindray patient monitor manuals need clarification of alarm functions
Certain operator's manuals for Mindray BeneVision N1 and N-Series patient monitors contain descriptions that may be insufficient or need clarification about selected physiological alarm functions.
Product
BeneVision N1 and N-Series Patient Monitor. Patient Monitor: N12/N15/N17/N19/N22.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0111-2027·2026-10-14
Mindray BeneVision Telemetry Monitor Manuals Recalled for Alarm Clarification
Mindray DS USA, Inc. is recalling BeneVision Series Telemetry Monitor operator's manuals because descriptions of selected physiological alarm functions may be insufficient or require clarification.
Product
BeneVision Series Telemetry Monitor. Operator's Manuals: TM70/TM80
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0116-2027·2026-10-14
Mindray T1 Patient Monitor Operator's Manual Recall for Alarm Descriptions
Mindray DS USA, Inc. is recalling T1 Patient Monitor Operator's Manuals because descriptions of physiological alarm functions may be insufficient or require clarification.
Product
T1 Patient Monitor. Operator's Manual: T1 Patient Monitor
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-3276-2026·2026-10-07
Volcano Corp Recalls Philips IntraSight Plus Systems Due to Data Error
Volcano Corp is recalling 19 Philips IntraSight Plus systems because software may incorrectly associate patient image data with the wrong medical record.
Product
Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-3227-2026·2026-10-07
Medline Homecare Bed Hand Pendants Recalled for Fire Hazard
Medline is recalling specific homecare bed hand pendants because the pendant or wiring may overheat, potentially leading to smoking, sparking, melting, burning, or fire.
Product
Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories, Hand Pendants: MDR510094 PENDANT F/ MDR107002E MDR520094 PENDANT F/ MDR107003E MDR530094 PENDANT, W/ 9V BATTERY BACKUP, F/ 2E BED MDR540094 PENDANT, W/ 9V BATTERY BACKUP, F/ 3E BED
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-3328-2026·2026-10-07
Spectrum Medical Recalls Quantum PureFlow Heat Exchangers Due to Leak Risk
Spectrum Medical SRL is recalling Quantum PureFlow Standard Heat Exchangers due to a risk of blood-to-glycol leaks during cardiopulmonary bypass procedures.
Product
Brand Name: Quantum PureFlow Product Name: Quantum PureFlow Standard Heat Exchanger High Flow 3/8 Model/Catalog Number: HX55W-S0 Software Version: N/A Product Description: The Quantum PureFlow Standard Heat Exchanger is intended to be used with a compatible Heater/Cooler…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-3327-2026·2026-10-07
Spectrum Medical Recalls Quantum PureFlow Heat Exchangers Due to Leak Risk
Spectrum Medical SRL is recalling Quantum PureFlow Standard Heat Exchangers because a defect may cause blood to leak into the glycol heat transfer fluid.
Product
Brand Name: Quantum PureFlow Product Name: Quantum PureFlow Standard Heat Exchanger High Flow 3/8 W Model/Catalog Number: HX55V-S0W Software Version: N/A Product Description: The Quantum PureFlow Standard Heat Exchanger is intended to be used with a compatible Heater/Cooler…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-3228-2026·2026-10-07
Medline Homecare Beds Recalled for Fire Hazard in Hand Control Pendant
Medline Industries is recalling Basic and Medlite Homecare Beds due to a potential fire hazard involving the hand control pendant and wiring.
Product
Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories MDR107000P BED, MANUAL, MEDLITE
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-3252-2026·2026-10-07
Draeger VentStar Resus Neo Neonatal Breathing Circuit Recall
Draeger is recalling VentStar Resus Neo neonatal breathing circuits due to potential hose cracks that could cause leakage or disconnection.
Product
VentStar Resus Neo. Neonatal. 25 Units per Box. Part Number: MP00310 Disposable breathing circuit for use with a resuscitation module.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-3331-2026·2026-10-07
Penumbra RED 62 Reperfusion Catheter Recalled for Fracture Risk
Penumbra Inc. is recalling 43 RED 62 Reperfusion Catheters due to manufacturing issues that may cause the catheters to fracture.
Product
Brand Name: Penumbra System (RED 62 Reperfusion Catheter) Product Name: Penumbra System (RED 62 Reperfusion Catheter) Model/Catalog Number: THNDRRED62SKIT Software Version: N/A Product Description: Product common name: Percutaneous catheter A complete product description…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-3294-2026·2026-10-07
FDA Recalls Medical Kits with Contaminated Pericare Wipes
American Contract Systems Inc. is recalling 1,804 medical kits containing BD CliniClean Pericare Wipes that may be contaminated with a manufacturing lubricant.
Product
Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays ABDOMINAL HYSTERECTOMY - 205989 Model No. MHAH55AM LAVH-LAP COLON Model No. SPLL54U VAG HYST PACK Model No. SPVH62P
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3155-2026·2026-10-07
Philips Spectral CT 7500 Software Recall for Radiation Exposure Risk
Philips is recalling Spectral CT 7500 software due to a tracking crash that may cause patients to receive additional radiation.
Product
Philips Medical Systems Technologies Ltd. Spectral CT 7500, Software V5.2.x, Product Code 728333
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3302-2026·2026-10-07
Heraeus Medical Recalls PALACOS R+G pro Bone Cement Due to Leakage Risk
Heraeus Medical GmbH is recalling PALACOS R+G pro 40 and 80 bone cement due to a potential for monomer liquid leakage. The recall affects 59,660 units distributed worldwide.
Product
PALACOS R+G pro 40; PALACOS R+G pro 80. Model/Catalog Number: 5081288; 5081289. Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3293-2026·2026-10-07
Recall of Medical Convenience Kits with Contaminated Pericare Wipes
American Contract Systems Inc. is recalling 1,804 medical convenience kits containing potentially contaminated perineal care wipes. The contamination may cause skin irritation or increase infection risk.
Product
Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays CARDIAC HEART BUNDLE NS Model No. LMCH99P OPEN HEART 2 RCH¿ 0248495 Model No. RCOH62C
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3324-2026·2026-10-07
Percussionaire Travel Air and Phasitron 5 Recall for Anesthetic Warning
Percussionaire Corporation is recalling Travel Air and Phasitron 5 devices to update labeling warnings regarding the use of intrapulmonary percussive ventilation with volatile anesthetic delivery systems.
Product
Travel Air, Product Number: S00055; Phasitron 5, Product Number: P5 used with Instruction Manual
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3296-2026·2026-10-07
Cardinal Health Recalls Presource Packs Due to Potential Handpiece Leakage
Cardinal Health 200, LLC is recalling 344 Presource Packs containing Stryker tube sets because handpieces may leak fluid, creating a slip and fall hazard.
Product
Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT,GU DAVINCI , Catalog Number: PGVMDVBWU; 2) KIT,GU DAVINCI , Catalog Number: PGVMDVBWV; 3) KIT,GU DAVINCI , Catalog Number: PGVMDVB26; 4) KIT,GU DAVINCI…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3301-2026·2026-10-07
Heraeus Medical Recalls PALACOS R pro Bone Cement Due to Leakage Risk
Heraeus Medical is recalling PALACOS R pro 40 and 80 bone cement because of a potential for monomer liquid leakage. The recall affects 33,727 units distributed worldwide.
Product
PALACOS R pro 40; PALACOS R pro 80. Model/Catalog Numbers: 5081286; 5081287. Radiopaque, poly (methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3291-2026·2026-10-07
FDA Recalls Opportunity Pro Nitrile Gloves Due to Manufacturing Defects
American Nitrile Operations LLC is recalling 17,481,000 Opportunity Pro nitrile gloves nationwide due to defects like tears and debris that may expose users to pathogens or chemicals.
Product
Brand Name: Opportunity Pro Product Name: Opportunity Pro Model/Catalog Number: 72-50800, 72-50801,72-50802,72-50803,72-50804 Product Description: Blue Nitrile patient examination glove
Category
Medical Device
Distribution
Distributed nationwide

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101–125 of 40397