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 13543

HighFDA (Devices)·Z-0983-2025·2025-01-29
HALYARD Laparotomy Surgical Pack Recalled for Additive Residue Contamination
O&M HALYARD is recalling HALYARD Laparotomy Packs due to elevated residues of anti-block/slip additives found in the sterile packaging. These surgical instruments were distributed nationwide.
Product
Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Description: Laparotomy Pack Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0995-2025·2025-01-29
Olympus Thunderbeat Surgical Hand Instruments Recalled for Damaged Probe Tips
Olympus has recalled Thunderbeat surgical hand instruments because the probe tips can become damaged or broken, including pad damage and detachment. The recall affects 36,712 units distributed internationally outside the United States.
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: N5424030 Software Version: N/A Product Description: Thunderbeat instrument is a s
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0981-2025·2025-01-29
Stryker neurosurgical device labeling mismatch: wrong instruments shipped
Stryker is recalling 3.0MM Neuro Match Head devices (REF 5820-107-430) where the actual device may not match the product label, potentially causing surgeons to use wrong instruments during neurosurgery.
Product
stryker 3.0MM Neuro Match Head, REF 5820-107-430, used to cut bone and bone cement during neurosurgery
Category
Medical Device
Distribution
Distributed nationwide
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-1005-2025·2025-01-29
Medical Analyzer Software May Fail to Alert of Expired Reagent Packs
The VITROS 5600 Integrated System's software (version 3.8.0 and higher) may fail to notify users when Signal Reagent Packs expire. This could result in use of expired reagents, causing no results or erroneous results from tests.
Product
Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: 6802413 (New), 6802415 (Certified/Refurbished), 6904001 (China) Software Version: version 3.8.0 or higher Product Description: In vitro diagnostic chemistry analyzer. FDA 3 letter product
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0969-2025·2025-01-29
Otological Ventilation Tubes Recalled for Lack of FDA 510(k) Clearance
Adept Medical Ltd is recalling 2,440 otological ventilation tubes due to lack of FDA 510(k) regulatory clearance. The recall affects 1,940 units in the US and 500 units distributed internationally.
Product
Otological Ventilation Tube - Donaldson - Blue Silicone; Product Code: NZ3321;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0978-2025·2025-01-29
Integra implantable hydrocephalus valve recalled for incorrect product description on labels
Integra LifeSciences is recalling CODMAN CERTAS Plus Programmable Valves (Model 828810PL) due to incorrect product descriptions on internal and external labels. The mislabeling affects 170 units distributed across the US and several international locations.
Product
CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810PL. 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-0967-2025·2025-01-29
Otological Ventilation Tube Recalled Due to Lack of Regulatory Clearance
Adept Medical Ltd is recalling otological ventilation tubes distributed without FDA 510(k) clearance. The recall affects approximately 2,190 units in the US.
Product
Otological Ventilation Tube - T-Tube 12mm - Silicone; Product Code: NZ3312;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0965-2025·2025-01-29
Otological Ventilation Tubes Recalled for Lack of FDA Premarket Clearance
Adept Medical Ltd is recalling 2,610 T-Tube 9mm otological ventilation tubes distributed without required FDA premarket 510(k) clearance. The affected silicone tubes were sold in the US and internationally.
Product
Otological Ventilation Tube - T-Tube 9mm - Double - Silicone; Product Code: NZ3309-2;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0964-2025·2025-01-29
Otological Ventilation Tubes Distributed Without FDA 510(k) Clearance
Adept Medical Ltd is recalling 2,010 units of T-Tube 6mm Double Silicone otological ventilation tubes distributed without required FDA 510(k) clearance. The recall affects 630 US units and 1,380 international units.
Product
Otological Ventilation Tube - T-Tube 6mm - Double - Silicone; Product Code: NZ3306-2;
Category
Medical Device
Distribution
Distributed nationwide
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-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-0968-2025·2025-01-29
Otological Ventilation Tubes recalled due to lack of FDA 510(k) clearance
Adept Medical Ltd is recalling 310 units of Otological Ventilation Tubes (Product Code NZ3312-2) distributed in the US and internationally due to lack of FDA 510(k) regulatory clearance. The devices were distributed without required FDA pre-market approval.
Product
Otological Ventilation Tube - T-Tube 12mm - Double - Silicone; Product Code: NZ3312-2;
Category
Medical Device
Distribution
Distributed nationwide
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-0980-2025·2025-01-29
Stryker Surgical Burs Recalled Due to Package Label Mismatch
Stryker Corporation is recalling surgical burs that may be packaged with incorrect labels, causing a mismatch between the device model inside and the label. Approximately 491 affected devices were distributed worldwide.
Product
The 3.0MM Neuro Match Head Soft Touch bur (5820-107-030) is intended to be used to cut bone and bone cement during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT)/Otology/Neurotology/ Otorhinolaryngology, orthopedic, and general surgic
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-0984-2025·2025-01-29
Medtronic Pediatric Arterial Cannulae Recalled for Incorrect Labeling
Medtronic is recalling 745 DLP Pediatric Arterial Cannulae (Models 77008 and 77014) due to incorrect labeling affecting seven manufactured lots distributed nationwide and worldwide.
Product
DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)
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-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
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
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-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-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

How to read this listing

Filters

4001–4025 of 13543