Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

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.

20376–20400 of 50413

HighFDA (Devices)·Z-1655-2021·2021-05-26
Bard Groshong Catheter Recall for Connector Defects
Bard Access Systems is recalling specific lots of Groshong NXT ClearVue Catheters due to connector defects that may prevent proper catheter passage or locking.
Product
REF 7617408D, Groshong NXT ClearVue Catheter, Maximal Barrier Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741035262 - Product Usage: is designed for use when central venous catheterization is prescribed.
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·21V397000·2021-05-26
2021 KZRV SPORTTREK and STRATUS trailers water heater circuit fire hazard
KZRV is recalling 2021 SPORTTREK and STRATUS trailers with incorrectly sized water heater circuit breakers. The wiring defect may prevent proper electrical protection and increase fire risk.
Product
KZRV — KZRV SPORTTREK, STRATUS
Category
Vehicle
Distribution
Distributed nationwide
HighCPSC·21141·2021-05-26
Target Recalls Room Essentials Shower Stools Due to Fall Hazard
Target is recalling Room Essentials Shower Stools because they can become unstable or slippery, posing a fall hazard. About 58,500 units were sold.
Product
Room Essentials Shower Stools
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1596-2021·2021-05-26
Roche Recalls Troponin I Immunoassay Kits Due to False Negative Risk
Roche Diagnostics is recalling 726 Elecsys Troponin I Immunoassay kits because they may produce false negative results when run immediately after proBNP II tests on specific modules.
Product
Elecsys Troponin I Immunoassay: Catalog# 05094810160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1611-2021·2021-05-26
Medtronic Guardian Sensor 3 Recalled for Inaccurate Glucose Readings
Medtronic is recalling Guardian Sensor 3 units worldwide because use with hydroxyurea may cause inaccurate elevated glucose readings.
Product
Medtronic REF: MMT-7020C5 Guardian Sensor (3) for the following packaging: GS3 5PK 1L AUS/ GTIN: 20763000252056 GS3 5PK 1L AUS/ GTIN: 20763000414362 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1601-2021·2021-05-26
Medtronic Guardian Sensor 3 Recalled for Inaccurate Readings with Hydroxyurea
Medtronic is recalling Guardian Sensor 3 units because use with the drug hydroxyurea may cause inaccurate elevated glucose readings.
Product
Medtronic REF: MMT-7020A, Guardian Sensor (3) for the following packaging: GS3 5PK 2L US/ GTIN: 20763000140940 GS3 5PK 2L US/ GTIN: 20763000337005 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose…
Category
Medical Device
Distribution
0 states
HighCPSC·21139·2021-05-26
Ergobaby Recalls METROUS Strollers Due to Choking Hazard
Ergobaby is recalling METROUS strollers because a harness buckle button can break and detach, posing a choking hazard to young children.
Product
METROUS1, METROUS2 and METROUS4 Compact City Strollers
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1669-2021·2021-05-26
Bard Groshong NXT ClearVue Catheter Recall for Connector Defects
Bard Access Systems is recalling specific lots of Groshong NXT ClearVue Catheters due to connector defects that may prevent proper catheter passage or locking.
Product
REF 7617407, Groshong NXT ClearVue Catheter, Full Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741035248 - Product Usage: is designed for use when central venous catheterization is prescribed.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0537-2021·2021-05-26
PepsiCo Recalls Evolve Protein Shakes Due to Undeclared Soy
PepsiCo is recalling Evolve Double Chocolate Plant-Based Protein Shakes because they contain undeclared soy. The recall covers 17,381 cases distributed nationwide.
Product
Evolve Double Chocolate Plant-Based Protein Shake, 11oz "Tetra Pak" carton, sold 4 cartons per retail unit. UPC on retail 4 pack: 876063007887 Packed 3 retail four packs per wholesale case.
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1612-2021·2021-05-26
Medtronic Guardian Sensor 3 Recall for Hydroxyurea Interaction
Medtronic is recalling Guardian Sensor 3 units worldwide because use with hydroxyurea may cause inaccurate high glucose readings.
Product
Medtronic REF: MMT-7020D1 Guardian Sensor (3) for the following packaging: GS3 1PK OUS1/ GTIN: 00643169704084 GS3 1PK 9L OUS1/ GTIN: 00763000243333 GS3 1PK 9L OUS1/ GTIN: 00763000318857 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1646-2021·2021-05-26
Biopsybell Cement Delivery Kits Recalled for Potential Sterility Failure
Biopsybell is recalling 305 units of 10 Gauge Single Cement Delivery kits because they were labeled sterile but may not have been sterilized.
Product
10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES, CODE INTVM-SCDK
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1602-2021·2021-05-26
Medtronic Guardian Sensor 3 Recall Due to Hydroxyurea Interference
Medtronic is recalling Guardian Sensor 3 units because use with the drug hydroxyurea can cause inaccurate, elevated glucose readings.
Product
Medtronic REF: MMT-7020B, Guardian Sensor (3) for the following packaging: GS3 1PK 2L US/GTIN: 00763000140779 GS3 1PK 2L US/ GTIN: 00763000337049 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1666-2021·2021-05-26
Bard Groshong NXT ClearVue Catheter Recall for Connector Defects
Bard Access Systems is recalling specific Groshong NXT ClearVue Catheters because connector defects may prevent proper catheter passage or locking.
Product
REF CK000379, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Full Kit, 4F, Single-Lumen, TLS, CE 2797, UDI: (01)10801741102704 - Product Usage: is designed for use when central venous catheterization is prescribed.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0535-2021·2021-05-26
Wolfie's Crunchy Cheddar & Jalapeno Peanuts Recalled for Undeclared Milk
Wolfies Group Inc is recalling Crunchy Cheddar & Jalapeno Peanuts due to undeclared milk on the label. The product was distributed across all 50 states.
Product
Wolfie's Crunchy Cheddar & Jalapeno Peanuts Packaged in a Rice Paper Stand Up Pouch with Clear Poly Plastic Bag inside 5oz - 12 bags per case 14oz - 6 bags per case 28oz - 4 bags per case 80oz sold as individual bag
Category
Food
Distribution
0 states
HighFDA (Devices)·Z-1657-2021·2021-05-26
Bard Groshong NXT ClearVue Catheter Recalled for Connector Defects
Bard Access Systems is recalling Groshong NXT ClearVue Catheters because connector defects may prevent proper catheter passage or locking.
Product
REF 7655405J, Groshong NXT ClearVue Catheter, Basic Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741200615 - Product Usage: is designed for use when central venous catheterization is prescribed.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0523-2021·2021-05-26
Newly Weds Bread Crumbs Recalled for Foreign Material
Newly Weds Foods Inc is recalling 489 bags of bread crumbs due to the presence of foreign material. The recall covers distribution to manufacturers and distributors in 17 states and Mexico.
Product
Newly Weds B70731 bread crumbs X1, 25lbs bag
Category
Food
Distribution
16 states
HighFDA (Devices)·Z-1604-2021·2021-05-26
Medtronic Guardian Sensor 3 Recalled for Inaccurate Readings with Hydroxyurea
Medtronic is recalling Guardian Sensor 3 units because use with the drug hydroxyurea may cause inaccurate elevated glucose readings.
Product
Medtronic REF: MMT-7020LA, Guardian Sensor (3) for the following packaging: GS3 5PK US/ GTIN: 20763000336985 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1667-2021·2021-05-26
Bard Access Systems Recalls Groshong NXT ClearVue Catheters Due to Connector Defects
Bard Access Systems is recalling specific lots of Groshong NXT ClearVue Catheters because connector defects may prevent proper catheter passage or locking.
Product
REF CK000516, Groshong NXT ClearVue Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet, Full Kit, 4F, Single-Lumen, TPS, CE 2797, UDI: (01)10801741107891 - Product Usage: is designed for use when central venous catheterization is prescribed.
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·21V395000·2021-05-26
2017–2021 Holiday Rambler and Fleetwood Motorhomes Recalled for Improperly Sealed Flooring
REV Recreation Group is recalling 2017–2021 Fleetwood, Holiday Rambler, and Fleetwood motorhomes with improperly sealed floor holes that could allow carbon monoxide into the living area. Dealers will reseal the floor free of charge.
Product
HOLIDAY RAMBLER — HOLIDAY RAMBLER, FLEETWOOD VACATIONER, BOUNDER, SOUTHWIND
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Food)·F-0494-2021·2021-05-26
Public Goods Hair, Skin, & Nails Supplement Recalled for Undeclared Soy
Public Goods is recalling Hair, Skin, & Nails dietary supplements because they may contain undeclared soy. Consumers with soy allergies should stop using the product.
Product
PUBLIC GOODS brand HAIR, SKIN, & NAILS Dietary Supplement; 60 tablets per bottle; Other ingredients: Stearic acid; croscarmellose sodium, magnesium stearate, aqueous film coating (purified water, hydroxypropyl methylcellulose, vegetable glycerin), microcrystalline cellulose.…
Category
Food
Distribution
51 states
HighNHTSA·21V394000·2021-05-26
Pierce Recalls 2017-2021 Commercial Vehicles Due to Fuel Rail Leak Risk
Pierce Manufacturing is recalling 2017-2021 Arrow XT, Enforcer, Impel, Quantum, Saber, and Velocity vehicles because a sealing washer defect may cause high-pressure fuel leaks, increasing fire risk.
Product
PIERCE — PIERCE ARROW XT, ENFORCER, VELOCITY, IMPEL
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1616-2021·2021-05-26
Medtronic Guardian Sensor 3 Recalled for Inaccurate Readings with Hydroxyurea
Medtronic is recalling Guardian Sensor 3 units worldwide because use with the drug hydroxyurea may cause inaccurate elevated glucose readings.
Product
Medtronic REF: MMT-7020D5 Guardian Sensor (3) for the following packaging: GS3 1PK 1L AUS/ GTIN 00763000252069 GS3 1PK 1L AUS/ GTIN 00763000414375 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1624-2021·2021-05-26
Bioseal Central Line Dressing Kits Recalled for Potential Mold Growth
Bioseal Corporation is recalling 580 Central Line Dressing Kits because the included ChloraPrep applicator may allow Aspergillus penicillioides growth, potentially breaching package integrity.
Product
Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC009/20, Sterile EO, Single Use Only, UDI: (01)00630094430096
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1650-2021·2021-05-26
Medtronic Recalls Two Defective Implantable Cardioverter Defibrillators
Medtronic is recalling two Cobalt HF Quad MRI SureScan CRT-D devices due to a potential missing resistance spot weld.
Product
Cobalt HF Quad MRI SureScan Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D) - Product Usage: are multiprogrammable cardiac devices that monitor and regulate a patient s heart rate by providing single- or dual chamber rate responsive…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1595-2021·2021-05-26
Roche Recalls Troponin I STAT Immunoassay Kits Due to False Negative Risk
Roche Diagnostics is recalling 10,489 Troponin I STAT Immunoassay kits because they may produce false negative results when run after proBNP II tests on specific modules.
Product
Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.
Category
Medical Device
Distribution
Distributed nationwide