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

3951–3975 of 13449

ModerateFDA (Devices)·Z-0977-2025·2025-01-29
Programmable Valve Device Recalled Due to Incorrect Product Description Labels
CODMAN CERTAS Plus Programmable Valve (Model 828810) units were distributed with incorrect product descriptions on labels. 132 units affected across multiple U.S. states and international locations.
Product
CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810 Implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0986-2025·2025-01-29
Medtronic Arterial Cannula Recall Due to Incorrect Labeling
Medtronic Perfusion Systems is recalling Select Series Angled Tip Arterial Cannulas (Model 72422) due to incorrect labeling. The recall involves 440 units distributed nationwide.
Product
Select Series Angled Tip Arterial Cannula, Model Number 72422 (22 Fr)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0975-2025·2025-01-29
BD Pyxis Med ES Medication Cabinet Drawer and Door Failure Recall
CareFusion recalls the BD Pyxis Med ES Auxiliary medication cabinet due to drawer and door failures that may delay access to medications. Three failure modes identified: door latch failure, cable ribbon damage, and magnet falling out.
Product
BD Pyxis Med ES Auxiliary (AUX), REF 343
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0970-2025·2025-01-29
Otological Ventilation Tube Recalled Due to Lack of FDA Clearance
Adept Medical Ltd is recalling otological ventilation tubes distributed without FDA 510(k) clearance. The recall affects 4,080 units distributed in the US and internationally.
Product
Otological Ventilation Tube - Donaldson - Double - Blue Silicone; Product Code: NZ3321-2;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0979-2025·2025-01-29
CODMAN CERTAS Plus programmable valve recalled for incorrect label descriptions
Integra LifeSciences is recalling 46 units of the CODMAN CERTAS Plus Programmable Valve due to incorrect product descriptions on internal and external labels. The affected devices were distributed nationwide across the U.S. and internationally.
Product
CODMAN CERTAS Plus Programmable Valve Right Angle Valve Only. Model Number: 828820. Implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.
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-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-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-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-0714-2025·2025-01-22
Endoscopic Access Overtube Recalled for Risk of Obstruction and Pressure Buildup
Trokamed is recalling a 20 Fr. endoscopic access overtube due to risk of obstruction and dangerous kidney pressure buildup during procedures. If inflow speed is too quick, rapid fluid flow can restrict outflow and cause intrarenal pressure to accumulate.
Product
Sheath, 20 Fr., 160 mm (REF: WA2PS20L), 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
SevereFDA (Devices)·Z-0713-2025·2025-01-22
Endoscopic Access Overtube May Cause Dangerous Pressure Buildup During Procedures
Trokamed's endoscopic access overtube may cause rapid pressure buildup in the kidney if inflow speed is too fast. The device can become obstructed by tissue and blood fragments, restricting outflow.
Product
Sheath, 20 Fr., 130 mm (REF: WA2PS20S), gastroenterology-urology endoscopic access overtube.
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-0765-2025·2025-01-22
Medline Fluid Delivery Sets Recalled Due to Assembly Error
Medline Fluid Delivery Sets were incorrectly assembled with macro drip chambers instead of required micro drip chambers. The macro chamber delivers three times more fluid per drop, creating a risk of dosing errors.
Product
Medline Fluid Delivery Set with Drip Chamber: 1) MTO,135,YELLOW,MICRO,SPK-MAIMONIDES, Item Number: 60130527; 2) MTO,ANGIO,DOUBLE,SPIKE,KIT,KENNEDY HLTH, Item Number: 65111341; 3) MTO,ANGIO,SINGLE,SPIKE,KIT, Item Number: 65232486; 4) MTO,ANGIO,SINGLE,SPIKE,KIT,GOOD,SAM, Item
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0829-2025·2025-01-22
Impella RP Heart Pump Recalled Due to Optical Sensor Damage Risk
Abiomed is recalling 1,560 units of the Impella RP with SmartAssist pump due to risk of optical sensor damage from device interactions. Damaged sensors may cause temporary or permanent pump malfunction.
Product
Impella RP with SmartAssist; Product Number: 0046-0035;
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0831-2025·2025-01-22
Dialysis Blood Circuit May Cause Excessive Fluid Removal
The AquaFlexFlow UF 500 Plus blood circuit may malfunction and remove excessive fluid from patients, causing a dangerous drop in blood volume. This risk is especially dangerous for pediatric patients.
Product
nuwellis AquaFlexFlow UF 500 Plus, REF 114156, Catalog Number A06163, extracorporeal blood circuit which is used with the Aquadex SmartFlow or Aquadex FlexFlow System
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0716-2025·2025-01-22
Endoscopic Access Overtube Sheath Recalled Due to Pressure Buildup Risk
Trokamed GmbH is recalling an endoscopic access overtube sheath due to risk of intrarenal pressure buildup when inflow speed is too fast. No injuries reported.
Product
Sheath, 18 Fr., 160 mm (REF: WA2PS18L), gastroenterology-urology endoscopic access overtube.
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-0905-2025·2025-01-22
Olympus MAJ-891 Forceps Recalled for Potential Biomaterial Retention During Reprocessing
Olympus recalls the MAJ-891 endoscope forceps/irrigation plug nationwide because improper reprocessing may leave biomaterial inside the device, creating a contamination risk.
Product
Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number: MAJ-891. This instrument is designed to be attached to the instrument channel port of Olympus endoscopes to allow both irrigation and the use of endo-therapy accessories.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0764-2025·2025-01-22
Medline Fluid Delivery Sets incorrectly assembled with wrong drip chamber
Medline fluid delivery sets were assembled with a macro drip chamber instead of the required micro drip chamber, delivering three times more fluid per drop and risking patient fluid overload.
Product
Medline Fluid Delivery Set with Drip Chamber: 1) FDS,135,CHMN,W/F,MLL,RC(2),PG, Item Number 99000069; 2) FDS,135,NV,MICRO-CHAMBER,W/FILTER,BLUE, Item Number 949000222; 3) FDS,135,NV,MICRO-CHAMBER,W/FILTER,GREEN, Item Number 949000224; 4) FDS,135,NV,MICRO-CHAMBER,W/FILTER,RE
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-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-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-0826-2025·2025-01-22
CRT-P Pacemakers Recalled for Potential Safety Mode Initiation Risk
Boston Scientific's ACCOLADE Family pacemakers, including VALITUDE CRT-P models, are recalled due to battery impedance defects that could trigger unintended Safety Mode during normal operation.
Product
VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0885-2025·2025-01-22
Welch Allyn Life2000 Ventilator Battery Charger May Cause Device Inoperability
Baxter Healthcare is recalling 946 Welch Allyn Life2000 ventilators due to a battery charger defect that can trigger an alarm and render the device inoperable.
Product
Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002A
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

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3951–3975 of 13449