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

10226–10250 of 36631

SevereFDA (Devices)·Z-0609-2021·2020-12-30
Cook Inc. Recalls Flexor Check-Flo Introducers Due to Sheath Separation Risk
Cook Inc. is recalling 631 Flexor Check-Flo Introducers because the sheath may separate at the proximal bond site, posing a risk of life-threatening adverse events.
Product
Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL1-HC, Order Number G56228 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0604-2021·2020-12-30
Cook Inc. Recalls Flexor Check-Flo Introducers Due to Separation Risk
Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate during use, potentially causing life-threatening adverse events.
Product
Flexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL0-HC, Order Number G56222 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0591-2021·2020-12-30
Cook Inc. Recalls Flexor Check-Flo Introducers Due to Sheath Separation Risk
Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate during use, potentially causing life-threatening adverse events.
Product
Flexor Check-Flo Introducer, RPN KCFW-4.0-35-55-RB-HFANL0-HC, Order Number G56229 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0593-2021·2020-12-30
Cook Inc. Recalls Flexor Check-Flo Introducer Sheaths Due to Separation Risk
Cook Inc. is recalling 458 Flexor Check-Flo Introducer sheaths because the proximal bond site may separate, potentially causing life-threatening adverse events such as embolization or hemorrhage.
Product
Flexor Check-Flo Introducer, RPN KCFW-4.0-35-70-RB-HFANL0-HC, Order Number G56219 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0653-2021·2020-12-30
CryoLife Recalls CryoPatch SG Pulmonary Human Cardiac Patch Units
CryoLife, Inc. is recalling two units of CryoPatch SG Pulmonary Human Cardiac Patch due to post-processing microbial culture test failures.
Product
CryoPatch SG Pulmonary Human Cardiac Patch. The patch is cryopreserved in a tissue culture medium containing cryoprotectants within the innermost pouch of a three-pouch packaging system. The packaging system not only withstands ultracold temperatures, but also allows for aseptic
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0605-2021·2020-12-30
Cook Inc. Recalls Flexor Check-Flo Introducers Due to Separation Risk
Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate during use, posing a risk of life-threatening adverse events.
Product
Flexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL1-HC, Order Number G56227 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0600-2021·2020-12-30
Cook Inc. Recalls Flexor Check-Flo Introducers Due to Separation Risk
Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate at the proximal bond site, potentially causing life-threatening adverse events during use.
Product
Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL0-HC, Order Number G56221 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0598-2021·2020-12-30
Cook Inc. Recalls Flexor Check-Flo Introducers Due to Sheath Separation Risk
Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate at the proximal bond site, posing a risk of life-threatening adverse events during use.
Product
Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL0-HC, Order Number G56231 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0603-2021·2020-12-30
Cook Inc. Recalls Flexor Check-Flo Introducers Due to Sheath Separation Risk
Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate at the proximal bond site, potentially causing life-threatening adverse events during use.
Product
Flexor Check-Flo Introducer, RPN KCFW-7.0-35-55-RB-HFANL1-HC, Order Number G49043 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0610-2021·2020-12-30
Cook Inc. Recalls Flexor Tuohy-Borst Side-Arm Introducers Due to Separation Risk
Cook Inc. is recalling 902 Flexor Tuohy-Borst Side-Arm Introducers because the sheath may separate during use, potentially causing life-threatening adverse events.
Product
Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN KSAW-5.0-38-90-RB-SHTL-FLEX-HC, Order Number G31133 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0601-2021·2020-12-30
Cook Inc. Recalls Flexor Check-Flo Introducers Due to Separation Risk
Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate during use, potentially causing life-threatening adverse events.
Product
Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL1-HC, Order Number G56226 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·F-0181-2021·2020-12-30
Maribel's Sweets Recalls Dark Chocolate Pearls Due to Undeclared Milk
Maribel's Sweets, Inc. is recalling Cacao Market Marie Belle New York Dark Chocolate Pearls because the product contains undeclared milk.
Product
CACAO MARKET MARIE BELLE NEW YORK; Dark Chocolate Pearls; Ingredients: Cocoa bean, sugar, biscuit cereals (wheat flour, sugar, wheat malt, wheat starch, raising agent: E500ii, palm oil, salt, vanilla flavoring 17%, cocoa butter, emulsifier (soy lecithin), natural vanilla extract;
Category
Food
Distribution
13 states
SevereFDA (Devices)·Z-0596-2021·2020-12-30
Flexor Check-Flo Introducer sheath separation recall due to potential life-threatening complications
The FDA is recalling the Flexor Check-Flo Introducer because its sheath may separate at the proximal bond site, potentially causing serious complications such as embolization, vessel injury, or hemorrhage.
Product
Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL0-HC, Order Number G56220 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0602-2021·2020-12-30
Cook Inc. Recalls Flexor Check-Flo Introducers Due to Separation Risk
Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate during use, potentially causing life-threatening adverse events.
Product
Flexor Check-Flo Introducer, RPN KCFW-7.0-35-55-RB-HFANL0-HC, Order Number G56232 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0608-2021·2020-12-30
Cook Inc. Recalls Flexor Check-Flo Introducers Due to Separation Risk
Cook Inc. is recalling 228 Flexor Check-Flo Introducers because the sheath may separate at the proximal bond site, potentially causing life-threatening adverse events.
Product
Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL0-HC, Order Number G56223 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0592-2021·2020-12-30
Cook Inc. Recalls Flexor Check-Flo Introducers Due to Separation Risk
Cook Inc. is recalling 383 Flexor Check-Flo Introducers because the sheath may separate at the proximal bond site, posing a risk of life-threatening adverse events during use.
Product
Flexor Check-Flo Introducer, RPN KCFW-4.0-35-55-RB-HFANL1-HC, Order Number G56234 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
Category
Medical Device
Distribution
Distributed nationwide
SevereNHTSA·20V813000·2020-12-28
Yamaha Recalls FJR1300 Motorcycles Due to Transmission Gear Crack Risk
Yamaha is recalling 2016-2020 FJR1300 motorcycles because a transmission gear can crack and break, potentially locking the rear wheel and causing a crash.
Product
YAMAHA — YAMAHA FJR1300
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·20E094000·2020-12-28
Summit Racing 6-Ton Jack Stands Recalled Due to Ratchet Bar Failure Risk
Autosales Inc. is recalling Summit Racing 6-Ton Jack Stands because the ratchet bar may fail, allowing the vehicle to fall. Owners should stop using the stands and contact Autosales for a refund.
Product
EQUIPMENT:MECHANICAL:ACCESSORY SCISSOR/SCREW/BOTTLE JACK/LIFT:STAND recall
Category
Consumer Product
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0168-2021·2020-12-23
AvKare Recalls Trazodone Hydrochloride Tablets Due to Sildenafil Packaging Mix-Up
AvKare Inc. is recalling 14,368 bottles of Trazodone Hydrochloride Tablets 100 mg because they were inadvertently packaged with sildenafil.
Product
TraZODONE Hydrochloride Tablets USP 100 mg, Rx Only, 1000-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-834-10
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Food)·F-0172-2021·2020-12-23
Holiday Cookie Platter Recalled for Undeclared Pecans
George DeLallo Co. is recalling Holiday Cookie Platters due to undeclared pecans, a major food allergen.
Product
Holiday Cookie Platter packaged in plastic container 20 OZ (1.25 LB) 567g. UPC 41415 88690
Category
Food
Distribution
6 states
SevereFDA (Drugs)·D-0143-2021·2020-12-23
Advanced Nutriceuticals Recalls LL-37 Vials Due to Sterility Concerns
Advanced Nutriceuticals is recalling LL-37 vials because production processes cannot assure sterility. The product was distributed to seven states.
Product
LL-37, 2000 MCG/ML, 2 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Category
Drug
Distribution
7 states
SevereFDA (Drugs)·D-0145-2021·2020-12-23
Zydus Recalls Lansoprazole Tablets for Failed Dissolution Specifications
Zydus Pharmaceuticals is recalling 15,144 cartons of Lansoprazole 15 mg tablets because they failed to meet dissolution specifications.
Product
LANSOPRAZOLE — LANSOPRAZOLE (LANSOPRAZOLE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0131-2021·2020-12-23
FDA Recalls AOD-9604 Vials Due to Sterility Concerns
Advanced Nutriceuticals, LLC is recalling AOD-9604 vials because production processes cannot assure sterility. The product was distributed in seven states.
Product
AOD-9604, 1200 MCG/ML, 5 ML vial The Guyer Institute of Molecular Medicine, Indianapolis, IN
Category
Drug
Distribution
7 states
SevereFDA (Drugs)·D-0135-2021·2020-12-23
Advanced Nutriceuticals Recalls GHRP Vials Due to Sterility Concerns
Advanced Nutriceuticals is recalling GHRP vials because production processes cannot assure sterility. The product was distributed in seven states.
Product
GHRP, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Category
Drug
Distribution
7 states
SevereFDA (Drugs)·D-0141-2021·2020-12-23
Advanced Nutriceuticals Recalls GHK-CU Vials Due to Sterility Concerns
Advanced Nutriceuticals is recalling GHK-CU vials because production processes cannot assure sterility. The product was distributed in seven states.
Product
GHK-CU, 10 MG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Category
Drug
Distribution
7 states

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10226–10250 of 36631