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

5426–5450 of 39968

HighFDA (Devices)·Z-0285-2025·2024-11-13
Endoscopic Vessel Harvesting System Recalled for Assembly Defect
Zimmer recalls the Venapax XL endoscopic vessel harvesting system due to assembly defects that may cause endoscope interference during surgery. A Gen 5 tail piece was incorrectly assembled to Gen 4 devices, affecting 432 units nationwide.
Product
Saphena Medical Venapax XL- Endoscopic Vessel Harvesting System for use in minimally invasive surgery allowing access for vessel harvesting and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. Item Number: VPX4000 (7273)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0287-2025·2024-11-13
Surgical neurological sponges recalled for detaching X-ray markers
American Surgical Company is recalling 390 units of Americot 20-01S neurological sponges used in surgery. The X-ray detectable barium strip may detach, potentially delaying the surgical process.
Product
Americot 20-01S (1/4" x 1/4") or 6mm x 6mm: Neurological sponges for use in the protection of neural tissue during surgery. Ref: 20-01S ¿ x ¿ inches or 6mm x 6mm) Component: N/A
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0320-2025·2024-11-13
Hillrom HScribe Holter System cardiac monitoring devices duplicate identifier risk
Hillrom HScribe Holter System monitoring devices may assign duplicate file identifiers, risking patient identification mismatches in medical systems that use the identifier to match patient data to cardiac recordings.
Product
Hillrom Welch Allyn HScribe Holter System; ambulatory monitoring
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0313-2025·2024-11-13
Beckman Coulter Access Cortisol Assay Recalled for Calibration Error
Beckman Coulter is recalling 149 units of the Access Cortisol assay due to an incorrect calibration curve parameter that may cause test delays and potential injuries.
Product
The Access Cortisol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cortisol levels in human serum, plasma (heparin, EDTA) and urine using the Access Immunoassay Systems.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0289-2025·2024-11-13
Medtronic DLP Aortic Root Cannula Recalled for Potential Sterility Breach
Medtronic is recalling 420 units of DLP Aortic Root Cannulas due to a potential sterility breach caused by a misaligned seal.
Product
Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery
Category
Medical Device
Distribution
7 states
ModerateFDA (Devices)·Z-0315-2025·2024-11-13
Biocare Medical Recalls IHC Kits Due to Potential Staining Failure
Biocare Medical is recalling specific IHC kits containing DAB Buffer because they may produce weak or no staining, leading to test failure.
Product
intelliPATH Universal HRP Detection Kit, REF: IPK5011G80, containing DAB Buffer, Catalog Number: IPBF5009G20; ONCORE Pro DAB Chromogen, REF: OPRI6056KT180, containing DAB Buffer, Catalog Number: OPRI6055T60; IP DAB Chromogen Kit 80 ml, REF: IPK5010G80, containing DAB Buffer,
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0317-2025·2024-11-13
Shimadzu FLUOROspeed X-ray System Software Recall for Image Display Failure
Shimadzu is recalling 30 FLUOROspeed X-ray systems because software may fail to display images when switching modes, potentially delaying or canceling examinations.
Product
The FLUOROspeed is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. FLUOROspeed may be used for emer
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0311-2025·2024-11-13
Intra-Aortic Balloon Catheters Recalled for Packaging Label Discrepancy
Datascope Corp. is recalling 160 units of MEGA 7.5Fr intra-aortic balloon catheters due to discrepant labeling between inner and outer packaging, which could cause confusion about proper use.
Product
MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0316-2025·2024-11-13
X-ray System Software May Fail to Display Images During Mode Switching
SHIMADZU CORPORATION's SONIALVISION G4 X-ray system may occasionally fail to display images when switching from fluoroscopy to radiography mode. This could result in examination delays or cancellations.
Product
SONIALVISION G4 is a multi-purpose X-ray R/F system. The equipment is suitable for radiographic and fluoroscopic examinations, including general radiography and pediatric examinations, excluding mammography.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0284-2025·2024-11-13
Canon Medical PET-CT System Software Malfunction Prevents Image Reconstruction
27 Canon Cartesion Prime PET-CT imaging systems may experience software processing failures during simultaneous imaging of multiple patients, necessitating repeat examinations. The issue occurs when PET acquisition or reconstruction for another patient is performed while reconstruction is in progress.
Product
Cartesion Prime, Digital PET-CT, Model: PCD-1000A/3D.004, PCD-1000A/3D, is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
Category
Medical Device
Distribution
18 states
ModerateFDA (Devices)·Z-0314-2025·2024-11-13
Adult Cap-ONE Biteblock devices recalled for expired product distribution
Nihon Kohden America Inc is recalling 17 Adult Cap-ONE Biteblock devices shipped after expiration dates. The single-use devices are intended for sampling CO2 and administering oxygen during endoscopy procedures.
Product
Adult Cap-ONE Biteblock REF YG-227T The cap-ONE Biteblock is intended to sample CO2 and administer supplemental oxygen, for patients who can wear a 20mm bite block, during endoscopy type procedures. The device is intended for single patient use only.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0288-2025·2024-11-13
iotaSOFT Plus Drive Unit Recalled Due to Incorrect GTIN Number
Iotamotion Inc. is recalling the iotaSOFT Plus Drive Unit (Lot #D500330) due to an incorrect GTIN number on the product label. Five devices were distributed in Iowa.
Product
iotaSOFT Plus Drive Unit, REF IM-05. The iotaSOFT Insertion System is intended to aid the surgeon in placement of cochlear implant electrode arrays into a radiographically normal cochlea by controlling the speed of implant insertion.
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-0208-2025·2024-11-06
Phasitron5 breathing circuits recalled for nickel-coated spring discoloration
Percussionaire Corporation is recalling Phasitron5 breathing circuits (P5-10, P5-HC, P5-UC-10) due to discolored fluid caused by an unintended nickel coating on the spring component reacting with medicated mist. 43,830 devices have been distributed across the U.S.
Product
Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary Percussive Ventilation, used to provide airway clearance therapy
Category
Medical Device
Distribution
40 states
SevereFDA (Devices)·Z-0092-2025·2024-11-06
VasoView HemoPro Vessel Harvesting System Recalled for Silicone Component Detachment
Maquet Cardiovascular is recalling the VasoView HemoPro Endoscopic Vessel Harvesting System due to silicone detachment from the Harvesting Tool Jaws during use. This FDA Class I recall affects 28,809 units worldwide.
Product
VasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W and VH-3500
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0222-2025·2024-11-06
Ambulatory Infusion System Batteries May Short Circuit and Overheat
CADD-Solis battery packs used in ambulatory infusion systems may develop internal short circuits causing battery case melting and charging circuit failure. The FDA Class I recall affects 138,039 units worldwide.
Product
CADD-Solis Li-ion Rechargeable Battery Packs, REF 21-2160-XX, which are also sold as a component of the following CADD Solis Ambulatory Infusion Systems: 21-2101-0100-50, 21-2101-0200-02, 21-2101-0200-03, 21-2101-0200-06, 21-2101-0200-07, 21-2101-0200-12, 21-2101-0200-14, 21-210
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0141-2025·2024-11-06
GE Healthcare Infant Incubator Recall: Airborne Formaldehyde Off-Gassing
GE Healthcare Giraffe Incubator Carestation CS1 units may release airborne formaldehyde residue during initial use. Manufacturer notified customers in June 2023 to run incubators for one week to off-gas any residual formaldehyde, which can cause eye irritation.
Product
GE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator. Model Numbers: 1) 2082844-002-01040417; 2) 2082844-002-01044956; 3) 2082844-002-01058424; 4) 2082844-002-01069017; 5) 2082844-002-01089666; 6) 2082844-002-01090474; 7) 2082844-002-01091269; 8) 208
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0277-2025·2024-11-06
Smith & Nephew Knee Prosthesis Recalled for Wrong Size Shipped
Smith & Nephew is recalling a knee prosthesis implant after a complaint indicated that a Size 3 LEFT component was shipped instead of the labeled Size 4 LEFT. Size mismatch poses a risk if the implant is placed without prior verification.
Product
smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 3 LEFT, REF 71421163; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0246-2025·2024-11-06
Surgical Patties and Strips Recalled for Elevated Endotoxin Levels
Codman Surgical Patties and Strips are being recalled due to higher-than-expected endotoxin levels in raw materials. Approximately 93,782 units were distributed worldwide for use in protecting tissue during surgery.
Product
SURG PAT XRAY 1X3 Model/Catalog Number: 801408. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0228-2025·2024-11-06
Hospital Bed Fails to Send Remote Alerts Through Nurse Call System
Hillrom Centrella Smart+ hospital beds may fail to send remote alerts through the Rauland Responder 5 Nurse Call System, though local bed alerts still function. This could delay nursing staff notification of patient needs.
Product
a. Hillrom Centrella Smart+ Medical-Surgical Hospital Bed, Product codes: P7900B000001, P7900B100010, P7900B100024, P7900B100208, P7900B100273, P7900B100304, P7900B000005, P7900B100011, P7900B100025, P7900B100212, P7900B100277, P7900B100307, P7900B000010, P7900B100017, P7900B10
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0249-2025·2024-11-06
Surgical patties and strips recalled for endotoxin contamination
Integra LifeSciences is recalling surgical patties and strips due to higher-than-expected endotoxin levels in raw materials. The contamination may have resulted in out-of-specification finished products.
Product
SURG STRP 1/4X6 Model/Catalog Number: 801450. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0239-2025·2024-11-06
Surgical Patties and Strips Recalled for Out-of-Specification Endotoxin
Integra LifeSciences is recalling Codman Surgical Patties and Strips (Model 801400) due to higher-than-expected endotoxin levels in raw materials that resulted in out-of-specification finished products.
Product
SURG PAT XRAY 1/2X1/2 Model/Catalog Number: 801400. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0281-2025·2024-11-06
Smith & Nephew Knee Prosthesis Component Packaging Error: Wrong Implant Shipped
Smith & Nephew is recalling a knee prosthesis component after discovering some packages contained a different implant than labeled. No illnesses or injuries have been reported.
Product
smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZE 5 LEFT, REF 71421015; Uncoated knee femur prosthesis, metallic
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-0248-2025·2024-11-06
Surgical Patties and Strips Recalled for Higher-Than-Expected Endotoxin
Integra LifeSciences is recalling surgical patties and strips (Model 801449) due to higher-than-expected endotoxin levels in raw materials that may have resulted in out-of-specification finished products.
Product
SURG STRP 1/8X6 Model/Catalog Number: 801449. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0234-2025·2024-11-06
Abbott STI and HPV Test Kits Recalled for Quality Control Failures
Abbott is recalling Alinity m STI and HPV test kits due to iron leaching that invalidates quality control checks, potentially compromising test result reliability.
Product
Abbott Alinity m STI AMP Kit, used with the Alinity m System, product codes: a) REF 09N17-095; b) REF 09N17-090; c) REF 09N17-091;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0247-2025·2024-11-06
Surgical patties and strips recalled for elevated endotoxin levels
Integra LifeSciences is recalling surgical patties and strips (Model 801409) used in surgery due to higher-than-expected endotoxin levels detected in raw materials. No illnesses have been reported.
Product
SURG PAT XRAY 3X3 Model/Catalog Number: 801409. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
Category
Medical Device
Distribution
Distributed nationwide

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5426–5450 of 39968