Severity 5 of 5

Critical recalls

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

What “critical” means here

Severity 5 (Critical) covers recalls where deaths or serious injuries have been reported, or where the agency itself classified the action as the highest severity (FDA Class I, NHTSA 'death/serious injury reported'). These are the recalls you should treat as urgent — stop using the product immediately and follow the agency's guidance. Common Severity-5 categories are pathogen-contaminated ready-to-eat foods (Listeria, E. coli O157, Salmonella), drug products with confirmed adverse-event reports, and vehicle defects with documented fatal crashes.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

1351–1375 of 7439

CriticalFDA (Drugs)·D-0254-2021·2021-02-24
Liq-E Recalls Optimus Hand Sanitizer Due to Methanol Contamination
Liq-E S.A. De C.V. is recalling 575 drums of Optimus Instant Hand Sanitizer because the product contains methanol and has lower ethanol content than labeled.
Product
OPTIMUS LUBRICANTS Instant Hand Sanitizer, (alcohol 70% v/v) 55 Gal (208 L) drum, Made in Mexico, Liq-E, S.A. DE C.V., Puerto Tampico No. 345 Col.. La Fe San Nicolas de Los Garza, Nuevo Leon, Mexico. C.P. 66477.UPC # 7 501799 118998
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0253-2021·2021-02-24
Optimus Lubricants Hand Sanitizer Recalled for Methanol Contamination
Liq-E S.A. De C.V. is recalling Optimus Lubricants Instant Hand Sanitizer because the product contains methanol and has lower ethanol content than labeled.
Product
OPTIMUS LUBRICANTS Instant Hand Sanitizer, (ethyl alcohol 70%) 8.5 Fl. Oz. (250 mL) bottle, Made in Mexico, Liq-E, S.A. DE C.V., Puerto Tampico No. 345 Col. La Fe San Nicolas de Los Garza, Nuevo Leon, Mexico. C.P. 66477. UPC # 7 501799 115621
Category
Consumer Product
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1114-2021·2021-02-24
Combat Medical Systems Recalls Fresh Whole Blood Donor Sets
Combat Medical Systems is recalling 954 Fresh Whole Blood Donor Sets due to a potential bent or disconnected needle in the kit components.
Product
Fresh Whole Blood Donor Set (P/N 80-801-D NSN 6515016640306) . Blood convenience kit. The Fresh Whole Blood Doner Set contains everything needed to test for ABO/Rh compatibility and collect the whole blood from donor.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Food)·F-0275-2021·2021-02-17
Maine Grains Organic Yellow Peas Recalled for Undeclared Soy
Maine Grains Inc. is recalling Organic Yellow Peas due to undeclared soy. The product was sold in various packaging formats across multiple states.
Product
Maine Grains Inc. brand Organic Yellow Peas sold between 10/17/2019 and 11/1/2020; product was packaged in 25lb bulk bags, 12 x 1lb cases; and clear cellophane 1lb bags sold online and labelled as "Crop Rotation Organic Yellow Peas"
Category
Food
Distribution
17 states
CriticalFDA (Drugs)·D-0262-2021·2021-02-17
Apotex Recalls Enoxaparin Syringes Due to Labeling Mixup
Apotex Corp. is recalling Enoxaparin Sodium Injection syringes because some barrels may display incorrect concentration markings, posing a risk of dosing errors.
Product
Enoxaparin Sodium Injection, USP 120 mg/ 0.8 mL Single Dose Syringes with Automatic Safety Device For Subcutaneous Injection 10 x 0.8 mL Single Dose Syringes Rx Only,Manufactured by: Gland Pharma Ltd. Hyderabad, India Manufactured for: Apotex Corp. Weston, FL 33326 NDC 60505-079
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Food)·F-0279-2021·2021-02-17
Sprout's Yogurt Covered Cranberries Recalled for Undeclared Almonds
Ohio Hickory Harvest is recalling Sprout's Vanilla Flavored Yogurt Covered Cranberries due to undeclared almonds, a tree nut allergen.
Product
Sprout's Vanilla Flavored Yogurt Covered Cranberries UPC 646670463778 12 Ounce Stand-Up Pouch Bag Ambient Storage
Category
Food
Distribution
0 states
CriticalFDA (Food)·F-0266-2021·2021-02-10
Frito-Lay Recalls Ruffles Potato Chips for Undeclared Milk
Frito-Lay is recalling specific bags of Ruffles Original Potato Chips because they may contain undeclared milk, posing a risk to consumers with milk allergies.
Product
RUFFLES "PARTY SIZE" ORIGINAL POTATO CHIPS 13 1/2 oz. UPC 028400034005 packaged in flexible bags
Category
Food
Distribution
6 states
CriticalFDA (Food)·F-0267-2021·2021-02-10
Hill Pharma Recalls Pea Protein Due to Possible Salmonella Contamination
Hill Pharma Inc is recalling 20,000 kilograms of Pisiva Pea Protein 80% due to possible Salmonella Worthington contamination. The product was distributed to one manufacturer in Wisconsin.
Product
Pisiva Pea Protein 80% 20 kg (44 lbs) packaged in poly lined kraft paper bags.
Category
Food
Distribution
1 state
CriticalNHTSA·21V050000·2021-02-05
GM Recalls Trucks and SUVs for Airbag Inflator Explosion Risk
General Motors is recalling specific 2007-2011 trucks and SUVs because the front passenger airbag inflators may explode due to humidity, posing a risk of serious injury or death.
Product
GMC — GMC, CHEVROLET, CADILLAC SIERRA 3500, YUKON, TAHOE, YUKON XL
Category
Vehicle
Distribution
Distributed nationwide
CriticalNHTSA·21V053000·2021-02-05
GM Recalls 2009-2013 Trucks and SUVs for Airbag Inflator Defect
General Motors is recalling specific 2009-2013 Chevrolet, GMC, and Cadillac vehicles because the front passenger airbag inflator may explode, sending metal fragments into the cabin.
Product
CHEVROLET — CHEVROLET, GMC, CADILLAC TAHOE, YUKON XL, SIERRA 1500, ESCALADE ESV
Category
Vehicle
Distribution
Distributed nationwide
CriticalNHTSA·21V051000·2021-02-05
GM Recalls 2012 Trucks and SUVs for Airbag Inflator Defect
General Motors is recalling 2012 Chevrolet, GMC, and Cadillac vehicles because the front passenger airbag inflators may explode, posing a risk of serious injury or death.
Product
CHEVROLET — CHEVROLET, GMC, CADILLAC SILVERADO 1500, SILVERADO 3500, YUKON, ESCALADE
Category
Vehicle
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0879-2021·2021-01-27
Boston Scientific Recalls Emblem S-ICD Subcutaneous Electrodes Due to Fracture Risk
Boston Scientific is recalling Emblem S-ICD Subcutaneous Electrodes because fractures may prevent the device from delivering therapy.
Product
EMBLEM S-ICD Subcutaneous Electrode Model 3501. Component of implantable cardioverter defibrillator (ICD)
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-0850-2021·2021-01-27
Penumbra JET 7 Reperfusion Catheter Recalled for Potential Tip Damage
Penumbra Inc. is recalling JET 7 Reperfusion Catheters because distal tip damage could cause vessel injury or death during use.
Product
Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF 5MAXJET7L138KIT The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) is a component of the Penumbra system. JET 7 Xtra Flex delivers aspiration from the Aspiration Pu
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0849-2021·2021-01-27
Penumbra JET 7 Reperfusion Catheter Recalled for Potential Vessel Damage
Penumbra Inc. is recalling JET 7 Reperfusion Catheters because distal tip damage could cause vessel injury or death during use.
Product
Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF 5MAXJET7KIT The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) is a component of the Penumbra system. JET 7 Xtra Flex delivers aspiration from the Aspiration Pump t
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0848-2021·2021-01-27
Penumbra JET 7 Reperfusion Catheter Recalled for Potential Tip Damage
Penumbra Inc. is recalling 3,368 JET 7 Reperfusion Catheters because the distal tip may become damaged during use, posing a risk of vessel damage and patient injury or death.
Product
Penumbra JET 7 Reperfusion Catheter REF 5MAXJET7 The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) is a component of the Penumbra system. JET 7 Xtra Flex delivers aspiration from the Aspiration Pump to the site of occlusion to assist in the ef
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0851-2021·2021-01-27
Penumbra JET 7MAX Kits Recalled for Potential Vessel Damage Risk
Penumbra Inc. is recalling JET 7MAX Kits because catheter tip damage during use could cause vessel damage, leading to patient injury or death.
Product
Penumbra JET 7MAX KIT Penumbra JET 7 Reperfusion Catheter+ MAX Delivery Device + Hi-Flow Aspiration Tubing REF J7XKIT132 The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) is a component of the Penumbra system. JET 7 Xtra Flex delivers aspirat
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Food)·F-0215-2021·2021-01-27
Listeria-contaminated cookie dough recalled from Rhino Foods, Inc.
FDA is recalling 20 lb. ready-to-eat chocolate chip cookie dough due to possible Listeria monocytogenes contamination.
Product
AF01886 NTFA No egg Ready-to-Eat Chocolate Chip Cookie Dough Dough- 20 lb. sold frozen
Category
Food
Distribution
1 state
CriticalFDA (Food)·F-0235-2021·2021-01-20
Divvies Vanilla Cupcakes Recalled for Undeclared Milk and Egg
Divvies LLC is recalling specific lots of vegan vanilla cupcakes because they contain undeclared milk and egg ingredients.
Product
"Divvies Vegan and Nut Free Vanilla Cupcakes with Vanilla Frosting ***Net. Wt. 6 oz. "
Category
Food
Distribution
3 states
CriticalFDA (Drugs)·D-0218-2021·2021-01-06
Wishgarden Herbs Recalls Happy Ducts Compress Due to Microbial Contamination
Wishgarden Herbs is recalling 46 jars of Happy Ducts Compress because the product tested positive for Cronobacter Sakazakii.
Product
Happy Ducts Compress, 3 oz. plastic jar, www.wishgardenherbs.com, Boulder, CO. 80301. UPC 6 56490 20223 5
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0220-2021·2021-01-06
WishGarden Herbs Recalls Goldenseal Powder Jars Due to Microbial Contamination
WishGarden Herbs is recalling 298 jars of Goldenseal Powder because testing found Cronobacter Sakazakii contamination.
Product
Goldenseal POWDER, 0.25 oz. (7 g) plastic jars, WishGarden Herbs, Inc., Boulder, CO 80301. UPC 6 56490 64137 9
Category
Food
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0599-2021·2020-12-30
Cook Inc. Recalls Flexor Check-Flo Introducer Sheaths Due to Separation Risk
Cook Inc. is recalling 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-6.0-35-55-RB-HFANL1-HC, Order Number G56236 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
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
CriticalFDA (Food)·F-0173-2021·2020-12-16
Hy-Vee Grill Ready Veggie Mix Recalled for Listeria
Hy-Vee is recalling Short Cuts Grill Ready Veggie Mix because an ingredient tested positive for Listeria monocytogenes.
Product
Hy-Vee, Short Cuts, Grill Ready Veggie Mix sold by weight in approximate 1 lb containers, Distributed by Hy-Vee Inc, West Des Moines, IA UPC 272104 XXXXXX
Category
Food
Distribution
8 states
CriticalFDA (Food)·F-0174-2021·2020-12-16
Hy-Vee Pot Roast Mix Recalled for Listeria Contamination
Hy-Vee is recalling Short Cuts Pot Roast Mix because an ingredient tested positive for Listeria monocytogenes. Consumers should discard the product.
Product
Hy-Vee, Short Cuts, Pot Roast Mix sold by weight in approximate 1 lb containers, Distributed by Hy-Vee Inc, West Des Moines, IA UPC 272083 XXXXXX
Category
Food
Distribution
8 states