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

3301–3325 of 27375

HighFDA (Devices)·Z-1001-2025·2025-01-29
Olympus Thunderbeat Hand Instruments Recalled for Probe Tip Damage and Breaking
Olympus is recalling Thunderbeat hand instruments because probe tips can be damaged or break, and pads can detach during use. No injuries have been reported.
Product
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Type S Model Number: TB-0520FCS Catalog Number/Product Code: N5423930 Software Version: N/A Product Description: Thunderbeat instrument is a
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1010-2025·2025-01-29
Baxter Clearlink system solution sets recalled for clamp defect
Baxter Healthcare is recalling specific lots of Clearlink System Solution Sets with inverted clamps that render the tubing unusable. The affected units are distributed nationwide in eight U.S. states.
Product
Baxter Clearlink System Solution Set with Duo-Vent Spike, REF 2R8538
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1002-2025·2025-01-29
Olympus Thunderbeat surgical instrument probe tips may damage or break
Olympus is recalling Thunderbeat surgical hand instruments due to damaged or breaking probe tips that may occur during use and affect surgical procedure safety.
Product
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Type S Model Number: TB-0520FCS Catalog Number/Product Code: N5424110¿ Software Version: N/A Product Description: Thunderbeat instrument is a
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0971-2025·2025-01-29
BD Pyxis MedStation ES Medication Dispenser Drawer and Door Failure Recall
BD Pyxis MedStation ES medication dispensing units may experience drawer and door failures due to latch failure, cable ribbon damage, or magnet displacement. These failures could delay access to medications in healthcare facilities.
Product
BD Pyxis MedStation ES (Med ES Main), REF 323
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0974-2025·2025-01-29
BD Pyxis MedStation 4000 Medication Cabinet Drawer and Door Failures
CareFusion 303 is recalling 5,056 BD Pyxis MedStation 4000 AUX units worldwide due to drawer and door failures that may delay medication access. Failures include door latch failure, cable ribbon damage, and magnet falling out.
Product
BD Pyxis MedStation 4000 AUX, REF 306
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0988-2025·2025-01-29
CardioMEMS HF Pressure Measurement System Recalled for Inaccurate Readings
St. Jude Medical is recalling the CardioMEMS HF Pressure Measurement System due to a cloud data migration that caused the system to revert to an outdated configuration, resulting in inaccurate pulmonary artery pressure readings.
Product
CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Patient Electronics System (PES) REF CM1100 Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Which interfaces with CardioMEMSTM HF System Patient Electronics System (PES) and CardioMEMSTM HF S
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0997-2025·2025-01-29
Olympus Thunderbeat Surgical Hand Instruments Recalled for Damaged Probe Tips
Olympus recalls 54,500 Thunderbeat surgical hand instruments due to probe tips that may be damaged or break. These sterile devices are used in ultrasonic surgical procedures.
Product
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,35 cm ,Front-actuated Grip Type S Model Number: TB-0535FCS Catalog Number/Product Code: N5423630 Software Version: N/A Product Description: Thunderbeat instrument is a s
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0972-2025·2025-01-29
BD Pyxis MedStation ES AUX medication dispenser drawer and door failures
The BD Pyxis MedStation ES AUX medication dispenser may experience drawer and door failures due to latch, cable, or magnet defects, potentially delaying access to medications. Approximately 39,615 units are affected worldwide.
Product
BD Pyxis MedStation ES AUX, REF 324
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0996-2025·2025-01-29
Olympus Thunderbeat Surgical Hand Instruments Recalled for Probe Damage
Olympus Corporation is recalling Olympus Thunderbeat front-actuated surgical hand instruments (Model TB-0535FCS) due to damaged or breaking probe tips and pad detachment. Approximately 128,608 units distributed outside the US are affected.
Product
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,35 cm, Front-actuated Grip Type S Model Number: TB-0535FCS Catalog Number/Product Code: N5423730 Software Version: N/A Product Description: Thunderbeat instrument is a
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0987-2025·2025-01-29
Heart Failure Monitoring System Unable to Transmit Patient Readings After Cloud Migration
The Merlin.net Heart Failure monitoring application cannot transmit patient readings after a data migration to a cloud environment. Some systems (25 total) distributed across 13 U.S. states are affected.
Product
Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Model MN6000) (Which interfaces with CardioMEMS" Hospital System model CM3100) The CardioMEMS" HF System provides pulmonary artery (PA) hemodynamic data used for monitoring and management of heart failure (H
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-1016-2025·2025-01-29
Dressing Change Tray Recalled Due to Potential Package Sterility Compromise
Trinity Sterile's Dressing Change Tray (Model TM6180CP, Lot 600032) is recalled because of a potential hole in the package that could compromise sterility. The recall affects 280 units distributed across Maryland, Pennsylvania, Tennessee, and Texas.
Product
Brand Name: Tacy Medical, Inc. Product Name: Dressing Change Tray CS/20 Model/Catalog Number: TM6180CP Software Version: N/A Product Description: Dressing change tray, case of 20, lot #600032, 50 cases affected. Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0768-2025·2025-01-29
Bodor P and C series laser cutting machines recalled for non-compliance
Jinan Bodor Cnc Machine Co Ltd is recalling 269 units of Bodor P and C series laser cutting machines distributed nationwide due to non-compliance with FDA standards.
Product
Bodor P and C series laser cutting machines
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1009-2025·2025-01-29
Baxter Solution Set with Duo-Vent Spike Recalled for Inverted Clamps
Baxter Healthcare is recalling specific lots of its Solution Set with Duo-Vent Spike due to inverted side clamps that may render the tubing unusable. The affected product was distributed nationwide.
Product
Baxter Solution Set with Duo-Vent Spike, REF 2R8404
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1012-2025·2025-01-29
Dressing change kits recalled due to packaging defect compromising sterility
Trinity Sterile is recalling Dressing Change Kits with ChloraPrep and HaloGUARD due to potential holes in the package that could compromise product sterility. The recall affects 1,980 units distributed across multiple states.
Product
Brand Name: IMed Products Product Name: Dressing Change Kit with ChloraPrep 3mL & HaloGUARD Model/Catalog Number: IM46062 Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600022, 66 cases affected. Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1003-2025·2025-01-29
Olympus Thunderbeat Surgical Instruments Recalled for Probe Tip Damage
Olympus is recalling Thunderbeat hand instruments (Model TB-0535FCS) because probe tips can be damaged or break during use. The recall affects 27,352 units distributed internationally.
Product
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: Thunderbeat, 5MM, 35CM, Front-actuated Grip Type S¿ Model Number: TB-0535FCS Catalog Number/Product Code: N5423810 Software Version: N/A Product Description: Thunderbeat instrument is a
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0884-2025·2025-01-22
Welch Allyn Life 2000 Ventilator Battery Charger Defect Causes Inoperability
The Welch Allyn Life 2000 Ventilator has a battery charger defect that could cause an alarm, rendering it inoperable. 187 units nationwide are affected in this FDA Class I recall.
Product
Welch Allyn, Inc., Life 2000 Ventilation System, REF BT-20-0002
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0830-2025·2025-01-22
Impella RP Flex Devices Recalled Due to Optical Sensor Damage Risk
Abiomed is recalling 2,364 units of the Impella RP Flex with SmartAssist due to risk of optical sensor damage from device interaction. Damage may cause temporary or permanent pump stop and loss of vital monitoring signals.
Product
Impella RP Flex with SmartAssist; Product Number: 1000323;
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0887-2025·2025-01-22
Life2000 Ventilation System battery charger defect causes device inoperability
Baxter Healthcare is recalling the Life2000 Ventilation System due to a battery charger defect that can trigger an alarm, rendering the ventilator inoperable and unable to support patients' breathing.
Product
Breathe Technologies, Inc., Life2000 Ventilation System, REF BT-20-0002AP
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0825-2025·2025-01-22
ALTRUA 2 DR Pacemaker Models S702 and S722 Safety Mode Risk
Boston Scientific ALTRUA 2 DR Pacemakers may unexpectedly enter Safety Mode during normal operation due to high battery impedance, potentially affecting device functionality.
Product
ALTRUA 2 DR Pacemaker, SL (Model Number S702) and EL (Model Number S722)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0824-2025·2025-01-22
ESSENTIO DR Pacemakers May Malfunction Due to Battery Impedance Issue
Boston Scientific is recalling certain ESSENTIO DR Pacemakers manufactured before September 2018 due to latent battery impedance that may cause Safety Mode malfunction during normal operations.
Product
ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL (Model Number L121), and EL MRI (Model Number L131)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0827-2025·2025-01-22
VISIONIST CRT-P Pacemakers Recalled Due to Battery Impedance Risk
Certain VISIONIST CRT-P pacemakers with latent high battery impedance may initiate Safety Mode unexpectedly during normal operations. Manufactured before September 2018, 156,329 units were distributed worldwide.
Product
VISIONIST CRT-P, EL (Model Number U225 and U226) and EL MRI (Model Number U228)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0822-2025·2025-01-22
ACCOLADE DR Pacemakers Recalled for Unintended Safety Mode Activation
Boston Scientific is recalling ACCOLADE DR Pacemakers built before September 2018 due to risk of unintended Safety Mode activation caused by battery impedance issues. The devices may enter Safety Mode during normal telemetry operations.
Product
ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (Model Number L321), and EL MRI (Model Number L331)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0821-2025·2025-01-22
Neo-Tee Resuscitator Spring Defect May Impair Pediatric Ventilation
Mercury Medical is recalling the Neo-Tee T-Piece Resuscitator due to an undersized spring in the circuit flow controller that may prevent reaching proper pressure ranges, potentially impairing emergency ventilation.
Product
Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Part: 1050805, 1050808, 1050809, 1050810, 1050811, 1050814, 1050832, 1050839, 1050840, 1050841, 1050842
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0715-2025·2025-01-22
Endoscopic Access Sheath Recalled Due to Risk of Intrarenal Pressure Buildup
Trokamed GmbH is recalling an endoscopic access sheath (18 Fr., 130 mm) used in gastroenterology and urology. Rapid fluid inflow may block outflow and cause dangerous pressure buildup inside the kidney.
Product
Sheath, 18 Fr., 130 mm (REF: WA2PS18S), gastroenterology-urology endoscopic access overtube.
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-0886-2025·2025-01-22
Welch Allyn Life2000 Ventilator Battery Charger Malfunction Recall
Baxter Healthcare Corporation is recalling Welch Allyn Life2000 Ventilation Systems due to a battery charger malfunction that triggers an alarm and renders the ventilator inoperable.
Product
Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002AP
Category
Medical Device
Distribution
Distributed nationwide

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3301–3325 of 27375