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

4026–4050 of 13512

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-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-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-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-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-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-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-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-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-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-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-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
HighFDA (Devices)·Z-0927-2025·2025-01-22
Sklar Instruments Recalls ECONO STERILE Trousseau Dilator Kits for Packaging Defects
Sklar Instruments is recalling ECONO STERILE trousseau dilator kits (Model 941-0191) distributed nationwide due to packaging issues that may compromise the sterile barrier. Affected healthcare providers should stop use immediately.
Product
ECONO STERILE medical procedure kits labeled as: ECONO STERILE TROUSSEAU DILATOR CS/25, Model Number 941-0191 (tracheal procedures)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0902-2025·2025-01-22
VITROS DGXN Slides Recalled Due to Hemoglobin Interference in Digoxin Measurement
VITROS DGXN Slides are recalled because hemoglobin can interfere with digoxin measurement, producing artificially low results. Approximately 1,541 units were distributed in the US and internationally.
Product
Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products DGXN Slides Model/Catalog Number: 8343386 Software Version: Not Applicable Product Description: The VITROS DGXN Slide is a multilayered, analytical element coated on a polyester support. Digoxi
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0933-2025·2025-01-22
Sklar Instruments Recalls ECONO STERILE Surgical Retractors Due to Packaging Issues
Sklar Instruments is recalling 1,050 ECONO STERILE surgical retractors nationwide due to packaging defects that may compromise sterility. The affected kits have potential breaches in their sterile barriers.
Product
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ARMY RETR (SET OF 2) STER CS25, Model Number 96-2243; 2) ECONO STERILE ARMY RETR (SET OF 2)STRL CS/25, Model Number 96-2243M; 3) ECONO STERILE SENN RETR DE BL 6.25"STRLCS/25, Model Number 96-2267; 4) ECONO
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0926-2025·2025-01-22
ECONO STERILE Medical Procedure Kits Recalled for Packaging Defects
Sklar Instruments is recalling ECONO STERILE medical procedure kits due to packaging issues that may compromise the sterile barrier and allow contamination.
Product
ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE FREER ELEV DE S/B 7.25" CS/25, Model Number 96-2483 (multiple purpose); 2) ECONO STERILE LOCKE ELEV #94 NARROW STER 25, Model Number 96-2484 (foot procedures)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0823-2025·2025-01-22
PROPONENT DR Pacemaker Recalled for Unexpected Safety Mode Risk
Boston Scientific is recalling certain PROPONENT DR pacemakers built before September 2018 due to latent battery impedance that could cause unexpected Safety Mode initiation during normal operation.
Product
PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0916-2025·2025-01-22
Cardinal Health Presource Surgical Kits Recalled for Potential Endotoxin Contamination
Cardinal Health is recalling Presource surgical kits due to potential endotoxin contamination in non-sterile surgical strips and patties. The recall affects 512,786 units distributed worldwide.
Product
Cardinal Health Presource Kits: 1) ORTHO PLASTIC MICROVASCULAR PK , Catalog Number: PGVMFFBLY; 2) ORTHO PLASTIC MICROVASCULAR PK , Catalog Number: PGVMFFBLZ; 3) KIT,NEURO SPINE,ANDERSON , Catalog Number: PN23SPAM5; 4) KIT, MAJOR SPINE , Catalog Number: PN33MSOC3; 5) KIT, MAJOR
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0882-2025·2025-01-22
Intuitive Surgical Bipolar Grasper Recall Due to Frayed or Broken Grip Cables
Intuitive Surgical is recalling 14,507 8MM Long Bipolar Graspers due to increased complaints of frayed or broken grip cables that could impair surgical control during laparoscopic procedures.
Product
8MM,LONG BIPOLAR GRASPER,IS4000 REF 471400
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0838-2025·2025-01-22
NOA Medical Industries Hospital Bed Side Rails Recalled for Defective Engagement Button
NOA Medical Industries is recalling 34 hospital bed side rails (Model 1055050GRY-BOX) because the red button used to engage the rails can break or become stuck, making it difficult to engage the safety rails.
Product
NOA Medical Industries Behavioral Health Hospital bed side rails, Product number 1055050GRY-BOX
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-0897-2025·2025-01-22
GE Healthcare Infinia II Systems Detector Fall Risk Recall
GE Healthcare recalls certain Infinia II and related nuclear medicine systems that may have been transported without proper detector support. This risk of detector fall could cause life-threatening bodily injury.
Product
GE Healthcare Infinia II, Model/Catalog Numbers: 1) H2799ZP; 2) H3000WT; System, Tomography, Computed, Emission
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0892-2025·2025-01-22
GE Healthcare nuclear medicine imaging systems recalled for detector mounting risk
GE Healthcare is recalling Discovery NM/CT nuclear medicine imaging systems that may fail if transported improperly. Unsupported detectors risk mounting mechanism failure and detector fall, potentially causing life-threatening injury.
Product
GE Healthcare Discovery NM/CT 670 DR, Model/Catalog Numbers: 1) 5376204-70-56-2; 2) H2401AW; 3) H3100AN; 4) H3100BT; 5) H3100PX; System, Tomography, Computed, Emission
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0908-2025·2025-01-22
Cardinal Health Presource Surgical Kits Recalled for Endotoxin Contamination
Cardinal Health is recalling Presource surgical kits due to potential endotoxin contamination in non-sterile surgical strips and patties. No illnesses have been reported.
Product
Cardinal Health Presource Kits: 1) KIT,PLASTIC FLAP,Catalog Number PGHDOT951; 2) KIT,ORP PLASTIC FLAP,Catalog Number PGHDOT952; 3) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT910; 4) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT911; 5) KIT,ORP PLASTIC FLAP,Catalog Number PWHD
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0962-2025·2025-01-22
Olympus LithoCrushV Mechanical Lithotriptor Recalled for Distal Tip Tearing Risk
Olympus Corporation recalls the LithoCrushV Single Use Mechanical Lithotriptor due to potential distal tip tearing during endoscopic procedures. The FDA Class II recall affects 989 units distributed nationwide.
Product
LithoCrushV Single Use Mechanical Lithotriptor V. Model Number: BML-V442QR-30. Single Use Mechanical Lithotriptor V used with Olympus endoscope for crushing calculi inside the bile duct.
Category
Medical Device
Distribution
Distributed nationwide

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4026–4050 of 13512