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.

1226–1250 of 7439

CriticalFDA (Devices)·Z-0118-2022·2021-11-03
Surgical Brain Guidance System Recalled for Inaccurate Electrode Placement
ROSA One 3.1 surgical guidance system recalled due to a software anomaly causing inaccurate electrode placement during brain and spine surgery. Manufacturer received 3 complaints related to the issue.
Product
ROSA One 3.1 Brain application The device is intended for the spatial positioning and orientation of instruments holders or tool guides to be used by trained surgeons to guide standard surgical instruments during brain and spine surgeries.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0010-2022·2021-10-27
Coppertone Pure & Simple 50 Sunscreen Spray Recalled for Benzene Contamination
Beiersdorf Inc. is recalling Coppertone Pure & Simple 50 Sunscreen Spray due to the presence of benzene, a chemical contaminant. The recall affects 38,328 cans distributed nationwide.
Product
Coppertone Pure & Simple 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02880 0
Category
Drug
Distribution
Distributed nationwide
CriticalCPSC·22007·2021-10-22
Walmart Better Homes and Gardens Room Spray Recalled for Dangerous Bacteria
Walmart is recalling Better Homes and Gardens Essential Oil Infused Aromatherapy Room Spray with Gemstones due to contamination with Burkholderia pseudomallei bacteria. CDC testing identified the hazard and is investigating a cluster of four melioidosis cases, including two deaths.
Product
Better Homes and Gardens Essential Oil Infused Aromatherapy Room Spray with Gemstones
Category
Consumer Product
Distribution
Distributed nationwide
CriticalUSDA FSIS·36-2021·2021-10-08
Nick’s Famous Bar-B-Q Recalls Smoked Pork for Listeria Risk
Nick’s Famous Bar-B-Q is recalling approximately 3,140 pounds of ready-to-eat smoked pork barbecue products due to possible Listeria monocytogenes contamination.
Product
I-65 BBQ, Inc. — Nick’s Famous Bar-B-Q Recalls Ready-To-Eat Pork Products Due to Possible Listeria Contamination
Category
Food
Distribution
1 state
CriticalFDA (Devices)·Z-2582-2021·2021-10-06
Ultrasound Gel Products Recalled for Possible Bacterial Contamination
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. The FDA recommends healthcare providers stop using these products immediately.
Product
Norco Ultrasound Gel, Item/Description: NC70479/Norco Ultrasound Gel, 250 mL; NC70479/North Coast Ultrasound Gel, 250 mL; NC70479-5/Norco Ultrasound Gel, 5 liters; NC70479-5/North Coast Ultrasound Gel, 5 liters; NC70479-5C/Norco Ultrasound Gel, 5 liters (4); NC70479-5C/North Coas
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2592-2021·2021-10-06
Atrium Pneumostat Chest Drain Valve Recalled Following Fatal Preterm Infant Case
Atrium Medical Corporation is recalling 92,430 units of its Pneumostat Chest Drain Valve after a preterm infant died during treatment with the device. The company is revising product labeling and warnings.
Product
Atrium Pneumostat Chest Drain Valve, Part Number 16100
Category
Medical Device
Distribution
Distributed nationwide
CriticalNHTSA·21V766000·2021-09-30
Volvo Recalls S60 and S80 Vehicles for Air Bag Inflator Defect
Volvo is recalling 2001-2009 S60 and 2001-2006 S80 vehicles because the driver's air bag inflator may explode during deployment, posing a risk of serious injury or death.
Product
VOLVO — VOLVO S60, S80
Category
Vehicle
Distribution
Distributed nationwide
CriticalUSDA FSIS·035-2021·2021-09-28
Espi's Recalls Frozen Chicken and Pork Hot Dogs Due to Listeria
Espi's Sausage and Tocino Co. is recalling frozen ready-to-eat chicken and pork hot dogs due to possible Listeria monocytogenes contamination.
Product
Espi's Sausage and Tocino Co. — Espi’s Sausage and Tocino Co. Recalls Ready-to-Eat Chicken and Pork Hot Dog Products Due to Possible Listeria Contamination
Category
Food
Distribution
1 state
CriticalCPSC·21198·2021-09-23
Boppy Newborn Loungers Recalled After Eight Infant Deaths
The Boppy Company is recalling approximately 3.3 million Boppy newborn loungers due to suffocation risk. Eight infant deaths have been reported associated with the product.
Product
Boppy Original Newborn Loungers, Boppy Preferred Newborn Loungers and Pottery Barn Kids Boppy Newborn Loungers
Category
Consumer Product
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2402-2021·2021-09-15
Pipeline Flex Embolization Device Recalled for Potential Push Wire Fracture Risk
Micro Therapeutics recalls Pipeline Flex Embolization Devices for potential push wire fractures in the delivery system during use. Device fractures in the Hypotube may result in malfunction during vascular procedures.
Product
Pipeline Flex Embolization Device
Category
Medical Device
Distribution
49 states
CriticalFDA (Devices)·Z-2392-2021·2021-09-15
Eco-Med ultrasound gels and lotions recalled for bacterial contamination
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. are being recalled due to potential bacterial contamination. The FDA issued a Class I recall on August 18, 2021, advising health care providers to stop using all affected products.
Product
LiquaSonic Ultrasound Gel 5L, Model No. 001222
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-2285-2021·2021-09-01
Monoject Sodium Chloride Flush Syringes Recalled for Air Embolism Risk
Cardinal Health recalls 267 million Monoject 0.9% Sodium Chloride Flush Syringes due to a plunger defect that may reintroduce air into the syringe, posing a risk of air embolism during IV administration.
Product
Monoject 0.9% Sodium Chloride Flush Syringe, 3 mL Fill, STERILE, Product Code 8881570123 The proposed device is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.
Category
Medical Device
Distribution
Distributed nationwide
CriticalUSDA FSIS·030-2021·2021-08-27
Fratelli Beretta Recalls Uncured Antipasto Meat Due to Salmonella Risk
Fratelli Beretta USA is recalling approximately 862,000 pounds of ready-to-eat uncured antipasto meat products due to possible Salmonella contamination.
Product
Fratelli Beretta USA, Inc. — Fratelli Beretta USA, Inc. Recalls Ready-to-Eat Uncured Antipasto Meat Products Due to Possible Salmonella Contamination
Category
Food
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2196-2021·2021-08-18
Heartware HVAD ventricular assist device recalled due to mortality risk
Medtronic recalled the Heartware HVAD Outflow Graft worldwide due to higher rates of neurological events and mortality compared to other left ventricular assist devices, plus pump restart failures.
Product
HeartWare HVAD Outflow Graft, REF MCS1725OG
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2192-2021·2021-08-18
HeartWare HVAD System Recalled Due to Higher Mortality Rates
Medtronic is stopping the HVAD System due to observational data showing higher mortality rates and neurological adverse events compared to other cardiac assist devices. The internal pump may also delay or fail to restart.
Product
HeartWare HVAD Driveline Extension Cable, REF 100
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2197-2021·2021-08-18
Heartware HVAD Pump Accessories Recalled Over Increased Mortality and Device Failures
Heartware is recalling HVAD Pump Accessories due to clinical data showing higher rates of neurological adverse events and mortality compared to other left ventricular assist devices, and reports of pump malfunctions.
Product
HeartWare HVAD Pump Accessories, REF MCS1753AK
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2191-2021·2021-08-18
HeartWare HVAD Pump Implant Kit Recalled for Increased Mortality and Device Failure
Medtronic is recalling 163 HeartWare HVAD Pump Implant Kits distributed worldwide due to higher rates of neurological adverse events, mortality, and pump malfunction compared to other cardiac assist devices.
Product
HeartWare HVAD Pump Implant Kit, REF 1153
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2195-2021·2021-08-18
HeartWare HVAD Implant Kit Recalled Over Higher Mortality Rates
Medtronic recalled the HeartWare HVAD Implant Kit due to higher rates of neurological adverse events and mortality compared to other left ventricular assist devices. The pump may also fail to restart.
Product
HeartWare HVAD Implant Kit, REF MCS1705PU
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2190-2021·2021-08-18
HeartWare HVAD heart pump implants recalled for neurological events and mortality
Medtronic is withdrawing 4,078 HeartWare HVAD implants worldwide due to higher frequency of neurological adverse events, mortality, and potential pump restart failures compared to other available devices.
Product
HeartWare HVAD Pump Implant Kit, REF 1125
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2194-2021·2021-08-18
HeartWare HVAD Heart Pump Recalled for Neurological Events and Mortality
Medtronic is recalling the HeartWare HVAD heart pump implant due to higher rates of neurological adverse events and mortality compared to other devices. The internal pump may also delay or fail to restart.
Product
HeartWare HVAD Implant Kit, REF 1104JP
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2188-2021·2021-08-18
FDA Recalls HeartWare HVAD Pump Implant Kit for Neurological Events and Mortality
Medtronic is recalling the HeartWare HVAD Pump Implant Kit due to higher rates of neurological adverse events and mortality compared to other heart pump devices. The pump may also delay or fail to restart.
Product
HeartWare HVAD Pump Implant Kit, REF 1103
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2193-2021·2021-08-18
HeartWare HVAD Driveline Extension Cable Recalled for Cardiac Safety Concerns
Medtronic is recalling the HeartWare HVAD Driveline Extension Cable (443 units) due to higher frequency of neurological adverse events and mortality in clinical comparisons with other heart assist devices. The pump may experience restart delays or failures.
Product
HeartWare HVAD Driveline Extension Cable, REF 100US
Category
Medical Device
Distribution
Distributed nationwide
CriticalCPSC·21179·2021-08-17
Zen Magnets and Neoballs Magnets Recalled Due to Ingestion Hazard
Zen Magnets and Neoballs high-powered spherical magnets are being recalled because swallowing multiple magnets can cause intestinal perforation, blockage, and death. About 10 million magnets sold individually and in sets since January 2009 are affected.
Product
Zen Magnets and Neoballs Magnets
Category
Consumer Product
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0677-2021·2021-07-28
Goose Creek Hand Sanitizer Recalled for Methanol and Chemical Contamination
Goose Creek Hand Sanitizer aloe Dragonfruit Splash (3.38 FL. OZ.) is being recalled because the product is contaminated with methanol, benzene, and acetaldehyde. Consumers should stop using the product immediately.
Product
Goose Creek Hand Sanitizer aloe Dragonfruit Splash, Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL), Goose Creek www.GooseCreekCandle.com, 1498 S. Wallace Wilkinson Blvd., Liberty, KY 42539, UPC 8 18489 01332 5
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0679-2021·2021-07-28
Goose Creek Hand Sanitizer Recalled for Methanol and Benzene Contamination
Scentsational Soaps & Candles Inc is recalling Goose Creek Hand Sanitizer aloe Melon Picnic spray (3.38 FL. OZ., Lot #20259) due to contamination with methanol, benzene, and acetaldehyde.
Product
Goose Creek Hand Sanitizer aloe Melon Picnic, Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL), Goose Creek www.GooseCreekCandle.com, 1498 S. Wallace Wilkinson Blvd., Liberty, KY 42539, UPC 8 14630 02424 0
Category
Drug
Distribution
Distributed nationwide