Severity 4 of 5

Severe recalls

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

What “severe” means here

Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.

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.

19351–19375 of 32115

SevereFDA (Devices)·Z-2613-2016·2016-08-31
Cook Inc. Recalls Shuttle Select Slip-Cath Catheters Due to Tip Fracture
Cook Inc. is recalling 60,302 Shuttle Select Slip-Cath catheters worldwide due to polymer degradation causing tip fracture and separation.
Product
Shuttle Select Slip-Cath Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2620-2016·2016-08-31
Cook Inc. Recalls Aprima Access Nonvascular Introducer Sets Due to Tip Fracture
Cook Inc. is recalling Aprima Access Nonvascular Introducer Sets because polymer degradation can cause the catheter tip to fracture or separate, potentially leading to medical complications.
Product
Aprima Access Nonvascular Introducer Set Accessories, Catheter Intended for single-puncture percutaneous access to facilitate placement of an .038 inch (0.97 mm) diameter working wire guide for interventional radiology procedures
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2660-2016·2016-08-31
Tecan Infinite F50 Absorbance Reader Recalled for Battery Overheating Risk
Tecan US, Inc. is recalling Infinite F50 absorbance readers because the batteries may overheat, melt, or char.
Product
Infinite F50 instrument. The INFINITE F50 instrument is a 96-well absorbance reader for the measurement of light absorbance (optical density) of liquid media. The instrument is intended to be used primarily in in-vitro diagnostic analysis of samples from the human body to…
Category
Medical Device
Distribution
19 states
SevereFDA (Devices)·Z-2649-2016·2016-08-31
Bovie Precise 360 Handpiece Recalled Due to Incomplete Tip Bond
Bovie Medical Corporation is recalling 95 units of the BVX-450NR Bovie Precise 360 Handpiece because the adhesive bond to the angled tip may be incomplete.
Product
BVX-450NR Bovie Precise 360 Handpiece 45cm, needle Product is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2650-2016·2016-08-31
Medtronic Recalls 78 Viva Quadripolar Implantable Cardioverter Defibrillators
Medtronic is recalling 78 Viva Quadripolar Implantable Cardioverter Defibrillators because a circuit defect may cause rapid battery depletion. Seven confirmed failures have been reported.
Product
Medtronic, Viva Quadripolar Implantable Cardioverter Defibrillators: Product Model VIVAXTCRT-D DTBA1D1, DTBA1D4 VIVASCRT-D DTBB1D1, DTBB1D4 Product Usage: The Medtronic Viva CRT -D dual chamber, implantable cardioverter defibrillator with cardiac…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2537-2016·2016-08-31
Cook Inc. Recalls Roadrunner Uniglide Hydrophilic Wire Guides Due to Glass Contamination
Cook Inc. is recalling Roadrunner Uniglide Hydrophilic Wire Guides because they may be contaminated with glass particles. The recall covers 8,750 devices distributed worldwide.
Product
Roadrunner Uniglide Hydrophilic Wire Guide, Catalog Numbers and GPN: HPWA-18-260, G30489; HPWA-18-320, G30490; HPWA-25-260, G30491; HPWA-35-260, G30492; HPWAS-35-260, G30506; HPW-35-150, G56149; HPW-35-180, G56150; HPWS-35-150, G56152; HPWS-35-180, G56153; HPWA-35-80, G56172…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2357-2016·2016-08-31
Alere INRatio2 PT/INR Testing System Recalled for Inaccurate INR Results
Alere San Diego is voluntarily recalling INRatio2 PT/INR Testing Systems because some patients showed significantly higher INR results in central laboratories than on the device.
Product
Alere INRatio2 PT/INR Professional Testing System Model Number: 0200431 Product Usage: The INRatio 2 PT Monitoring system is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The INRatio 2 PT Monitoring system is intended for…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2621-2016·2016-08-31
Cook Inc. Recalls Selective Salpingography Catheters Due to Tip Fracture Risk
Cook Inc. is recalling 7,819 Selective Salpingography Catheters with Beacon Tip due to polymer degradation that can cause the catheter tip to fracture or separate.
Product
Selective Salpingography Catheter with Beacon Tip Cannula, Manipulator/ Injector, Uterine Used for injection of contrast medium into the fallopian tube(s) for selective salpingography.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2661-2016·2016-08-31
Tecan INFINITE F50 Absorbance Reader Recalled for Battery Overheating Risk
Tecan US, Inc. is recalling 19 INFINITE F50 absorbance readers because the batteries may overheat, melt, or char.
Product
SUNRISE instrument. The INFINITE F50 instrument is a 96-well absorbance reader for the measurement of light absorbance (optical density) of liquid media. The instrument is intended to be used primarily in in-vitro diagnostic analysis of samples from the human body to obtain…
Category
Medical Device
Distribution
19 states
SevereFDA (Food)·F-1982-2016·2016-08-31
SM Fish Corp. Recalls Dublin Herring for Listeria Risk
SM Fish Corp. is recalling Ossie's Dublin Herring due to potential Listeria monocytogenes contamination. The product was distributed in New York and New Jersey.
Product
OSSIE'S DUBLIN HERRING, NET WT. 7 OZ., UPC 739885109002; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
Category
Food
Distribution
2 states
SevereFDA (Food)·F-1951-2016·2016-08-31
Northwest Wild Products Recalls Canned Seafood Due to Botulism Risk
Northwest Wild Products is recalling canned black cod, salmon, sardines, steelhead, sturgeon, tuna, and razor clams with codes starting with OC due to potential Clostridium botulinum contamination.
Product
Pacific Black Cod, NW Wild Products, 6.5 oz. metal cans. No UPC
Category
Food
Distribution
1 state
SevereFDA (Drugs)·D-1463-2016·2016-08-31
Talon Compounding Pharmacy Recalls Sermorelin Injections Due to Sterility Concerns
Talon Compounding Pharmacy is recalling Sermorelin and Sermorelin/GHRP-2 injections because the FDA cannot assure the products are sterile.
Product
Sermorelin 6 mg and Sermorelin 6 mg/GHRP-2 Injection, 12 mg, 10 ml depyrogenated vials, Rx Only, Compounded by Talon Compounding Pharmacy, San Antonio, TX 78247
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2664-2016·2016-08-31
Tecan Infinite M1000 Microplate Reader Recalled for Battery Overheating Risk
Tecan US, Inc. is recalling the Infinite M1000 microplate reader because its batteries may overheat, melt, or char.
Product
Tecan Infinite M1000 The Tecan Infinite M1000 is a multifunctional monochromator based microplate reader that provides high performance for the vast majority of todays microplate applications and research. Besides offering absorbance and fluorescence intensity measurements, the…
Category
Medical Device
Distribution
19 states
SevereFDA (Food)·F-1971-2016·2016-08-31
Eatin' Alive Recalls Thai Peanut Noodles for Undeclared Soy Allergen
Paige Common is recalling 24 units of Eatin' Alive Thai Peanut Noodles sold in Oregon due to undeclared soy.
Product
Eatin' Alive VEGAN GLUTEN FREE RAW thai peanut noodles. Keep Refrigerated. 8oz UPC 0 91037 56624 9
Category
Food
Distribution
1 state
SevereFDA (Food)·F-1953-2016·2016-08-31
Northwest Wild Products Recalls Canned Seafood Due to Botulism Risk
Northwest Wild Products is recalling various canned seafood products with codes starting with OC due to potential Clostridium botulinum contamination.
Product
Wild Columbia River Coho Salmon- Custom Packed, NW Wild Products, 6.5 oz. metal cans. No UPC
Category
Food
Distribution
1 state
SevereFDA (Food)·F-1955-2016·2016-08-31
Northwest Wild Products Recalls Canned Seafood for Botulism Risk
Northwest Wild Products is recalling various canned seafood products due to potential Clostridium botulinum contamination. Consumers should check for codes starting with OC.
Product
Columbia River Chinook Salmon -Custom Packed, NW Wild Products, 6.5 oz. metal cans. No UPC
Category
Food
Distribution
1 state
SevereFDA (Food)·F-1960-2016·2016-08-31
Northwest Wild Products Recalls Canned Fish Due to Botulism Risk
Northwest Wild Products is recalling various canned fish products, including sturgeon, due to potential Clostridium botulinum contamination.
Product
Wild Columbia River Sturgeon - Custom Smoked-NW Wild Products, 6.5 oz. metal cans. No UPC
Category
Food
Distribution
1 state
SevereFDA (Devices)·Z-2612-2016·2016-08-31
Cook Inc. Recalls Beacon Tip Catheters Due to Tip Fracture Risk
Cook Inc. is recalling Beacon Tip catheters because polymer degradation can cause the tip to fracture or separate, potentially leading to device fragments in the body.
Product
Beacon Tip Centimeter Sizing Catheter Beacon Tip White Vessel Sizing Catheter Beacon Tip Vessel Sizing Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·F-1987-2016·2016-08-31
SM Fish Corp. Recalls Ossie's Pickled Herring Due to Listeria Risk
SM Fish Corp. is recalling Ossie's Pickled Herring in 8 oz. plastic tubs because the manufacturing plant tested positive for Listeria monocytogenes. The product was distributed in New York and New Jersey.
Product
OSSIE'S PICKLED HERRING, NET WT. 8 OZ., UPC 739885104175; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
Category
Food
Distribution
2 states
SevereFDA (Devices)·Z-2618-2016·2016-08-31
Cook Inc. Recalls Liver Access and Biopsy Needle Sets Due to Tip Fracture
Cook Inc. is recalling 52,756 Liver Access and Biopsy Needle Sets because polymer degradation can cause the catheter tip to fracture or separate, potentially leading to device fragments in the body.
Product
Liver Access and Biopsy Needle Set Biopsy needle kit Intended for use in obtaining liver histology samples via a jugular vein approach.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·F-1964-2016·2016-08-31
Northwest Wild Products Recalls Canned Fish Due to Botulism Risk
Northwest Wild Products is recalling canned fish products with codes starting with OC due to potential Clostridium botulinum contamination.
Product
Pacific Black Cod- Custom Smoked -NW Wild Products, 6.5 oz. metal cans. No UPC
Category
Food
Distribution
1 state
SevereFDA (Food)·F-1962-2016·2016-08-31
Northwest Wild Products Recalls Canned Seafood Due to Botulism Risk
Northwest Wild Products is recalling canned seafood, including razor clams, due to potential Clostridium botulinum contamination. The products were distributed in Oregon via mail order.
Product
Wild Northwest Razor Clams - Custom Smoked-NW Wild Products, 6.5 oz. metal cans. No UPC
Category
Food
Distribution
1 state
SevereFDA (Food)·F-1984-2016·2016-08-31
SM Fish Corp. Recalls Ossie's Pickled Lox Due to Listeria Risk
SM Fish Corp. is recalling Ossie's Pickled Lox & Cream because the manufacturing plant tested positive for Listeria monocytogenes. The product was distributed in New York and New Jersey.
Product
OSSIE'S PICKLED LOX & CREAM, NET WT. 8 OZ., UPC 739885104113; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
Category
Food
Distribution
2 states
SevereFDA (Food)·F-1957-2016·2016-08-31
Northwest Wild Products Recalls Canned Seafood Due to Botulism Risk
Northwest Wild Products is recalling various canned seafood products with codes starting with OC due to potential Clostridium botulinum contamination.
Product
Wild Steelhead Salmon - Custom Packed-NW Wild Products, 6.5 oz. metal cans. No UPC
Category
Food
Distribution
1 state
SevereFDA (Devices)·Z-2611-2016·2016-08-31
Cook Inc. Recalls Beacon Tip Royal Flush Plus High-Flow Catheters
Cook Inc. is recalling 532,395 Beacon Tip Royal Flush Plus High-Flow Catheters worldwide due to polymer degradation that can cause the catheter tip to fracture or separate.
Product
Beacon Tip Royal Flush Plus High-Flow Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques. Standard techniques for placement of vascular access sheaths…
Category
Medical Device
Distribution
Distributed nationwide