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

8601–8625 of 27636

HighFDA (Devices)·Z-1166-2025·2025-02-19
Novation XLE hip implant components recalled for missing barrier layer
Exactech is recalling Novation XLE hip implant components due to absence of an Ethylene Vinyl Alcohol (EVOH) barrier layer. Patients with affected implants should contact their healthcare provider.
Product
Novation XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28-50 NV EHXLNTRL LNR G0 28MM 140-28-51 NV EHXLNTRL LNR G1 28MM 140-28-52 NV EHXL NTRL LNR G228MM 140-32-51 NV EHXL NTRL LNR G132MM 140-32-52 NV EHXL NTRL LNR G232MM 140-32-53 NV EHXL N
Category
Medical Device
Distribution
22 states
HighFDA (Food)·F-0563-2025·2025-02-19
Cheese powder ingredient blend recalled for plastic thread contamination
Bridgewell Agribusiness recalls 5912MOD-CAU Pre-Blend (lot 220349) due to plastic thread contamination. The dry ingredient was distributed only in New York.
Product
5912MOD-CAU Pre-Blend, item #991819, is a dry blend. Ingredients consist of Tapioca Starch, Long Grain Rice Flour, Cheese Powder [Cheddar Cheese (Cultured Pasteurized Milk, Salt, Enzymes), Disodium Phosphate, Salt], Rice Starch, Sugar, Salt, Encapsulated Baking Soda (Sodium Bicar
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-1141-2025·2025-02-19
Spore Test Monitoring System Printing Error May Cause Result Misdirection
HF Acquisition Co LLC is recalling Bio52 and Bio12 HealthFirst Mail In Monitoring Systems (4,021 units) due to a printing error on return envelopes that may cause spore test results to be reported to incorrect customer accounts.
Product
Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003600. Biological, Bio12 HealthFirst Mail In Monitoring System, 12 Tests, Item: 1003580
Category
Medical Device
Distribution
50 states
HighFDA (Food)·F-0546-2025·2025-02-19
Chocolate Drizzled Vanilla Granola Bars Recalled for Potential Metal Contamination
Riverside Natural Foods is recalling Chocolate Drizzled Vanilla Granola Bars nationwide due to potential metal piece contamination. Affected products should not be consumed.
Product
1.Chocolate Drizzled Vanilla Granola Bars 25.5oz (30 bars) 2. Chocolate Drizzled Vanilla Granola Bars 4.2oz (5 bars) 3. Chocolate Drizzled Vanilla Granola Bars 0.85oz
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1124-2025·2025-02-19
Medication Cabinet Recall: BD Pyxis MedStation Auxiliary 4000 Drawer and Door Failures
The BD Pyxis MedStation Auxiliary 4000 medication cabinet may experience drawer and door failures, potentially delaying medication access in healthcare facilities.
Product
BD Pyxis MedStation Auxiliary 4000 REF: 306. Intended to securely store and dispense medications to a qualified and authorized healthcare provider.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1100-2025·2025-02-19
Medical laser device recalled for inadequate safety operating instructions
Ithera Medical is recalling the MSOT Acuity Echo medical laser device worldwide due to inadequate instructions for safe operation. Previous user manuals contained an incorrect Nominal Ocular Hazard Distance value.
Product
The MSOT Acuity Echo is a Class 4 medical laser device. The MSOT Acuity is a mobile assembly of electrically-powered components intended for imaging and analysis of soft-tissue and vasculature using combined optoacoustic (photoacoustic) and ultrasound (US) imaging.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0558-2025·2025-02-19
Lemon Jelly Sticks recalled for undeclared Yellow #5 and Potassium Sorbate
The Candy Basket Inc. recalls Lemon Jelly Sticks WHITE because the label fails to disclose Yellow #5 dye and Potassium Sorbate. Consumers with sensitivities to these additives may be at risk.
Product
Lemon Jelly Sticks WHITE, item number CB750-W, is packed and sold in bulk 4lbs. boxes. Product does not have a UPC and is not repackaged for retail. Product was sold out of bulk chocolate cases from candy stores to consumers without any labeling. Label on bulk 4lbs. box declar
Category
Food
Distribution
3 states
HighFDA (Devices)·Z-1121-2025·2025-02-19
LVIS Intraluminal Support Device May Fail to Deploy Properly
MicoVention Terumo LVIS stent devices may fail to advance from the introducer due to PTFE material on the stent loop. Eleven units (Lot 0000456768) distributed in China are affected.
Product
MicoVention Terumo, LVIS Intraluminal Support Device, REF: 213522-CAS, od, 3.5 mm, TL 22 mm, WL 18 mm, Sterile R, CE0297. The intended purpose of the LVIS Device is to serve as a stent-assisted coiling (SAC) device providing support to the embolic coils used in the treatment of
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1132-2025·2025-02-19
Cardinal Health Presource Surgical Kits Recalled for Potential Endotoxin Contamination
Cardinal Health is recalling approximately 973,785 Presource Kits due to potential endotoxin contamination in non-sterile surgical strips and patties. The kits were distributed to healthcare facilities worldwide.
Product
Cardinal Health Presource Kits: 1) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG4; 2) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG5 3) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG6 4) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG7 5) KIT,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0224-2025·2025-02-19
Irbesartan Tablets Recalled Due to Out-of-Specification Dissolution
AvKARE is recalling Irbesartan Tablets USP 300 mg due to dissolution failure, affecting 341 cartons distributed nationwide. Patients should contact their pharmacist or doctor regarding their medication.
Product
IRBESARTAN — IRBESARTAN (IRBESARTAN)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1138-2025·2025-02-19
Stryker Precision Thin Blade Attachments Recalled for Measurement Failure
Stryker Corporation is recalling 622 units of Precision Thin blade attachments that may be out of measurement specifications, preventing them from fitting securely into compatible handpieces.
Product
stryker Precision Thin, Catalog Number REF 2296-003-108; Micro Oscillating and Sagittal Blades
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1129-2025·2025-02-19
Cardinal Health Presource Surgical Kits Recalled for Endotoxin Contamination
Cardinal Health Presource Kits may contain endotoxin-contaminated non-sterile surgical strips and patties. These kits are used in surgical procedures and have been distributed worldwide including the US, Canada, and Saudi Arabia. Affected facilities should verify lot numbers against the recall list.
Product
Cardinal Health Presource Kits: 1) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV20110B; 2) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV20110D 3) KIT,CAROTID ENDARTERECTOMY, Catalog Number:PVV2CA103 4) KIT,CAROTID ENDARTERECTOMY, Catalog Number:PVV2CA10T 5) KIT,CAROTID E
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1168-2025·2025-02-19
MediHoney Gel Wound Dressing Recall: Potential Induction Seal Defect
Integra LifeSciences is recalling MediHoney Gel Wound & Burn Dressing Gel (Model 31815) due to potential induction seal defects in the tube packaging. Approximately 12,166 units were distributed worldwide, including throughout the United States and Malaysia.
Product
Brand Name: MediHoney¿ Gel Product Name: MediHoney¿ Wound & Burn Dressing Gel Model/Catalog Number: 31815 Software Version: N/A Product Description: MediHoney¿ Gel with Active Leptospermum Honey is a moist dressing made of Active Leptospermum Honey in combination with gelling
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1165-2025·2025-02-19
Exactech AcuMatch XLE Hip Implants Recalled Due to Missing Protective Barrier Layer
Exactech recalled AcuMatch XLE hip implants due to the absence of the Ethylene Vinyl Alcohol (EVOH) barrier layer. Approximately 42 units were distributed in the U.S. and internationally.
Product
AcuMatch XLE Item Number / Product Description: 140-28-27 AM EHXL 0¿ LNR G 28MM 140-32-27 AM EHXL 0¿ LNR G 32MM 140-32-28 AM EHXL 0¿ LNR H 32MM 140-28-29 AM EHXL 0¿ LNR J 28MM 140-32-29 AM EHXL 0¿ LNR J 32MM 140-36-29 AM EHXL 0¿ LNR J 36MM 140-32-30 AM EHXL 0¿ LNR K 32MM
Category
Medical Device
Distribution
22 states
HighFDA (Devices)·Z-1169-2025·2025-02-19
Vios Bedside Monitor Pulse Oximeter Sensor Premature Failure and Incorrect Warnings
Murata Vios, Inc. is recalling the Vios Monitoring System Bedside Monitor, Model BSM2050, due to premature failure of the pulse oximeter SpO2 sensor. When the sensor fails, the system displays an incorrect warning that may mask the actual monitoring problem.
Product
Vios Monitoring System Bedside Monitor, Model BSM2050, Software Version Numbers 1.54.20 and 1.56.00
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0557-2025·2025-02-19
Lemon Jelly Sticks DARK Recalled for Undeclared Yellow #5 and Potassium Sorbate
The Candy Basket Inc is recalling Lemon Jelly Sticks DARK (item CB750-D) for containing undeclared Yellow #5 and Potassium Sorbate. The product was sold in bulk boxes without retail packaging across California, Oregon, and Washington.
Product
Lemon Jelly Sticks DARK, item number CB750-D, is packed and sold in bulk 4lbs. boxes. Product does not have a UPC and is not repackaged for retail. Product was sold out of bulk chocolate cases from candy stores to consumers without any labeling. Label on bulk 4lbs. box declares
Category
Food
Distribution
3 states
HighFDA (Devices)·Z-1127-2025·2025-02-19
Cardinal Health Presource Kits recalled for endotoxin contamination risk
Cardinal Health is recalling Presource Kits containing surgical strips and patties due to potential endotoxin contamination. Approximately 973,785 units were distributed in the US, Canada, and Saudi Arabia.
Product
Cardinal Health Presource Kits: 1) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMM14; 2) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMMD9; 3) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMMDX;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1163-2025·2025-02-19
HPV Diagnostic Control Panel Recall Due to Quality Control Failures
Microbiologics is recalling a lot of HPV diagnostic control materials due to inadequate quality control during release. The control's HPV 16 L1 concentration is too low, potentially causing test failures and invalid results in clinical laboratories.
Product
Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet), REF 8234; in-vitro diagnostic test
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1128-2025·2025-02-19
Cardinal Health Urology Robotic Packs recalled for potential endotoxin contamination
Cardinal Health Presource Kits for robotic urology surgery are being recalled due to potential endotoxin contamination in surgical strips and patties. No adverse events have been reported.
Product
Cardinal Health Presource Kits: 1) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFA; 2) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFB; 3) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFC
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1131-2025·2025-02-19
Cardinal Health Laryngoscopy Packs Recalled for Potential Endotoxin Contamination
Cardinal Health Presource Kits containing laryngoscopy packs are being recalled due to potential endotoxin contamination in non-sterile surgical strips and patties.
Product
Cardinal Health Presource Kits: 1) LARYNGOSCOPY PACK, Catalog Number:SRIET0979N;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0547-2025·2025-02-19
Made Good Variety Pack recalled for potential metal contamination nationwide
Riverside Natural Foods is recalling Made Good Variety Pack products nationwide due to potential metal contamination. Consumers should not consume the products and return them to retailers.
Product
1. Made Good Variety Pack 37ct 2.MadeGood Variety Pack 7ct
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-0538-2025·2025-02-19
Chocolate Banana Granola Bars Recalled for Potential Metal Contamination
Riverside Natural Foods is recalling Chocolate Banana Granola Bars sold nationwide due to potential metal contamination. Consumers should not eat affected products and should consult a healthcare provider if consumed.
Product
1. Chocolate Banana Granola Bars; 5.1oz (6 bars) 2. Chocolate Banana Granola Bars; 0.85oz
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1135-2025·2025-02-19
Cardinal Health Presource surgical kits recalled for endotoxin contamination risk
Cardinal Health is recalling Presource Kits for potential endotoxin contamination in non-sterile surgical strips and patties. These surgical components could pose infection risks if used in procedures.
Product
Cardinal Health Presource Kits: 1) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP11; 2) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP12 3) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP13 4) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP1E 5) CHI STD SPINE OPTION 2, Catalog
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1167-2025·2025-02-19
Exactech Alteon XLE Hip Replacement Liners Recalled for Missing Barrier Layer
Exactech is recalling Alteon XLE hip replacement liners due to a manufacturing defect. Some units lack the Ethylene Vinyl Alcohol barrier layer required for proper device function.
Product
Alteon XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28-50 NV EHXLNTRL LNR G0 28MM 140-28-51 NV EHXLNTRL LNR G1 28MM 140-28-52 NV EHXL NTRL LNR G228MM 140-32-51 NV EHXL NTRL LNR G132MM 140-32-52 NV EHXL NTRL LNR G232MM 140-32-53 NV EHXL N
Category
Medical Device
Distribution
22 states
HighFDA (Devices)·Z-1170-2025·2025-02-19
Hologic Sertera-14 Biopsy Device Recalled for Inner Needle Separation Risk
Hologic is recalling 55,335 Sertera-14 biopsy devices nationwide because the inner needle can separate from the hub, creating a risk of needle dislodgement during use.
Product
Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Sertera-14 Software Version: N/A Product Description: Instrument, Biopsy Component: N/A
Category
Medical Device
Distribution
Distributed nationwide

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8601–8625 of 27636