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

9151–9175 of 31219

HighFDA (Devices)·Z-1015-2025·2025-01-29
Dressing Change Kit Recalled Due to Package Integrity Concern
Trinity Sterile is recalling Wolf-Pak Premium Dressing Change Kits due to potential holes in packaging that could compromise sterility. The recall affects 5,940 units distributed in Maryland, Pennsylvania, Tennessee, and Texas.
Product
Brand Name: Wolf-Pak Product Name: Premium Dressing Change Kit with GuardiVa & Statlock CS/30 Model/Catalog Number: DC5090LF Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600088, 198 cases affected. Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0985-2025·2025-01-29
Medtronic Recalls EOPA Arterial Cannula Models for Labeling Errors
Medtronic Perfusion Systems is recalling EOPA Arterial Cannula models 77418 and 77422 due to incorrect labeling on seven manufacturing lots. Approximately 930 units were distributed worldwide.
Product
EOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0982-2025·2025-01-29
Stryker 3.0MM Neuro Precision Head Recalled for Package Labeling Mismatch
Stryker is recalling the 3.0MM Precision Neuro Match Head due to a packaging discrepancy where the device may not match the product label. Approximately 1,489 units distributed worldwide are affected, including lot numbers 22179047, 22179027, and 22160017.
Product
stryker 3.0MM Precision Neuro Match Head, REF 5820-107-530, used to cut bone and bone cement during neurosurgery
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-1004-2025·2025-01-29
BD PCR Cartridges for MAX System signal drift in select lots
Specific lots of BD PCR Cartridges used with the MAX System may experience signal drift, potentially affecting diagnostic accuracy. BD has initiated a recall of 516,435 affected units worldwide.
Product
BD PCR Cartridges used with MAX System. Model Number: 437519
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1018-2025·2025-01-29
Randox Lipoprotein (a) Diagnostic Assay Lacks FDA Clearance, Recalled
Randox Laboratories is recalling 33 Randox Lipoprotein (a) diagnostic kits nationwide. The assay's claims for use on Roche Cobas c501 analyzers lack required FDA clearance or approval.
Product
Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP2757
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0994-2025·2025-01-29
Olympus Thunderbeat Hand Instrument Probe Tips May Break or Detach
Olympus is recalling the Thunderbeat surgical hand instrument because the probe tips are being damaged or breaking. The recall affects 34,325 units distributed in the US and internationally.
Product
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: Thunderbeat Front-Actuated Grip Type S Model Number: TB-0545FCS Catalog Number/Product Code: R5000688 Software Version: N/A Product Description: Thunderbeat instrument is a sterile, sing
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
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-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 (Drugs)·D-0208-2025·2025-01-29
Venlafaxine Extended-Release Tablets Recalled for Missing Tablet Identification
Appco Pharma LLC is recalling Venlafaxine Extended-Release Tablets, 150mg, due to missing tablet identification imprints. The defect affects 1,380 bottles distributed nationwide.
Product
VENLAFAXINE — VENLAFAXINE (VENLAFAXINE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0205-2025·2025-01-29
Kissable Diabetics Foot Cream recalled nationwide for inadequate release testing
Brands International Corporation is recalling Kissable Diabetics Foot Cream nationwide due to lack of adequate release testing during manufacturing. The FDA has classified this as a Class II recall.
Product
Kissable Diabetics Foot Cream, NET WT 4 oz (113 g) per tube, Manufactured By: Brands International Corp., Newmarket, ON, L3X 2S2. UPC 6 72008 80925 3
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0408-2025·2025-01-29
River Valley Ranch Spinach Artichoke Dip Mix Recalled for Underprocessing
River Valley Ranch & Kitchens Spinach Artichoke Dip Mix (224 jars, Wisconsin) has been recalled due to underprocessing. Affected batches are 40124113001, 40124113002, and 40124113003.
Product
River Valley Ranch & Kitchens Spinach Artichoke Dip Mix. net wt. 16 oz. (453g). UPC 6 92016-40021 1. Keep Refrigerated After Opening. 39900 60th Street, Burlington, WI 53105.
Category
Food
Distribution
1 state
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-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-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-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-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
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 (Food)·F-0405-2025·2025-01-29
Mr. Bing Sriracha Chili Sauce Recalled for Possible Spoilage
Mr. Bing brand Sriracha Chili Sauce in 9 oz and 18 oz bottles is being recalled because it may contain spoilage organisms. Affected consumers should not use the product.
Product
Mr. Bing brand Sriracha Chili Sauce; 9 oz and 18 oz, in clear PET bottle with green cap; UPC 850044819072 and UPC 850044819058
Category
Food
Distribution
9 states
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-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-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

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9151–9175 of 31219