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.

19376–19400 of 32115

SevereFDA (Devices)·Z-2662-2016·2016-08-31
Tecan Infinite 200 Absorbance Reader Recalled for Battery Overheating Risk
Tecan US, Inc. is recalling 5 units of the Tecan Infinite 200 absorbance reader because the batteries may overheat, melt, or char.
Product
Tecan Infinite 200. The SUNRISE 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-1963-2016·2016-08-31
Northwest Wild Products Recalls Canned Seafood Due to Botulism Risk
Northwest Wild Products is recalling various canned seafood products, including razor clams, because they may be contaminated with Clostridium botulinum.
Product
Wild Northwest Razor Clams - Custom Packed-NW Wild Products, 6.5 oz. metal cans. No UPC
Category
Food
Distribution
1 state
SevereFDA (Devices)·Z-2617-2016·2016-08-31
Cook Inc. Recalls Kumpe Access Catheters Due to Tip Fracture Risk
Cook Inc. is recalling 26,076 Kumpe Access Catheters because polymer degradation can cause the tip to fracture or separate, potentially leading to device fragments in the body.
Product
Kumpe Access Catheter Cathether, Ureteral, General & Plastic Surgery Used in combination with a HiWire, Bentson, or other flexible-tipped wire guide to gain difficult ureteral access beyond a redundant or tortuous ureteral segment
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·F-1974-2016·2016-08-31
Laxmi Nutkhhata Golden Raisins Recalled for Undeclared Sulfites
House of Spices is recalling Laxmi Nutkhhata Golden Raisins because they contain undeclared sulfites, a major food allergen.
Product
LAXMI NUTKHHAT Golden Raisins, Net Wt. 200g (7 oz), Product of USA -- Distributed by House of Spice Flushing, NY
Category
Food
Distribution
5 states
SevereFDA (Devices)·Z-2359-2016·2016-08-31
Alere INRatio 2 Home Monitor Recalled for Inaccurate INR Readings
Alere San Diego is voluntarily recalling INRatio 2 home monitors because they may display inaccurate INR results compared to central laboratory tests.
Product
Alere INRatio2 Replacement Monitor (Home) Model Number: 0200457 Product Usage: Alere INRatio 2 PT/INR Home Monitoring System: The Alere INRatio 2 PT/INR Home Monitoring System, consisting of the INRatio 2 Home Monitor and INRatio PT/INR test strip, is used for quantitative…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2615-2016·2016-08-31
Cook Inc. Recalls FluoroSet Radiographic Tubal Assessment Sets
Cook Inc. is recalling 1,881 FluoroSet Radiographic Tubal Assessment Sets due to polymer degradation that can cause catheter tip fracture or separation.
Product
FluoroSet Radiographic Tubal Assessment Set Cannula, Manipulator/ Injector, Uterine Used for instillation of contrast media into the uterine cavity for radiographic evaluation of the uterine cavity and for injection of appropriate contrast media into the fallopian tubes for…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2663-2016·2016-08-31
Tecan Infinite 200 PRO Microplate Reader Recalled for Battery Overheating
Tecan US, Inc. is recalling 27 Infinite 200 PRO microplate readers because the batteries may overheat, melt, or char.
Product
Infinite 200 PRO The Tecan Infinite 200 PRO is a multifunctional microplate reader with injector option. The Infinite 200 PRO provides high performance for the vast majority of todays microplate applications and research and is robotic compatible. The Infinite 200 PRO has been…
Category
Medical Device
Distribution
19 states
SevereFDA (Devices)·Z-2361-2016·2016-08-31
Alere INRatio PT/INR Test Strips Recalled for Inaccurate INR Readings
Alere San Diego is voluntarily recalling INRatio PT/INR test strips and meters because they may display therapeutic INR values that are significantly higher in central laboratory testing.
Product
Alere INRatio PT/INR Test Strips Model Number: 0100071, 0100139 Product Usage: The INRatio/INRatio2 Test Strips perform a modified version of the one-stage Prothrombin Time test, using a recombinant human thromboplastin reagent. The clot formed in the Prothrombin Time…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·F-1976-2016·2016-08-31
SM Fish Corp. Recalls Ossie's Pickled Lox Due to Listeria Risk
SM Fish Corp. is recalling Ossie's Pickled Lox Dairy because the manufacturing plant tested positive for Listeria monocytogenes. The product was distributed in New York and New Jersey.
Product
OSSIE'S PICKLED LOX DAIRY, NET WT. 8 OZ., UPC 739885114136; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
Category
Food
Distribution
2 states
SevereFDA (Food)·F-1966-2016·2016-08-31
Northwest Wild Products Recalls Canned Seafood Due to Botulism Risk
Northwest Wild Products is recalling various canned seafood products, including tuna, salmon, and black cod, due to potential Clostridium botulinum contamination.
Product
Pacific White Albacore Tuna - Custom Packed -NW Wild Products, 6.5 oz. metal cans. No UPC
Category
Food
Distribution
1 state
SevereFDA (Devices)·Z-2355-2016·2016-08-31
Alere INRatio PT/INR Monitoring Systems Recalled for Inaccurate INR Results
Alere San Diego is voluntarily recalling INRatio PT/INR Monitoring Systems because they may report inaccurate INR values, potentially leading to incorrect anticoagulant dosing.
Product
INRatio Prothrombin Time (PT) Monitoring System Model Number: 0100007 Product Usage: The INRatio Prothrombin Time Monitoring System uses a modified version of the one-stage PT test. After a drop of blood is applied to the test strip, it is drawn into the test area and…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·F-1983-2016·2016-08-31
SM Fish Corp. Recalls Honey Mustard Herring for Listeria Risk
SM Fish Corp. is recalling 336 containers of Ossie's Honey Mustard Herring due to potential Listeria monocytogenes contamination. The product was distributed in New York and New Jersey.
Product
OSSIE'S HONEY MUSTARD HERRING; NET WT. 7 OZ. 739885109019; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
Category
Food
Distribution
2 states
SevereFDA (Devices)·Z-2665-2016·2016-08-31
Tecan Infinite M1000 PRO Microplate Reader Recalled for Battery Overheating Risk
Tecan US, Inc. is recalling 11 Infinite M1000 PRO microplate readers because their batteries may overheat, melt, or char.
Product
Tecan Infinite M1000 PRO The Tecan Infinite M1000 PRO is a multifunctional monochromator-based microplate reader that provides high performance for the vast majority of todays microplate applications and research. In addition to offering absorbance and fluorescence intensity…
Category
Medical Device
Distribution
19 states
SevereFDA (Food)·F-1961-2016·2016-08-31
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 can codes and stop using affected items.
Product
Pacific White Albacore Tuna - Custom Smoked -NW Wild Products, 6.5 oz. metal cans. No UPC
Category
Food
Distribution
1 state
SevereFDA (Devices)·Z-2596-2016·2016-08-31
Conmed Dual Dispersive Electrodes Recalled for Burn Risk
Conmed is recalling Adult ThermoGard Dual Dispersive Electrodes because they may be incompatible with some electrosurgical generators, posing a risk of undetected pad lift and potential burns.
Product
Adult ThermoGard¿ Dual Dispersive Electrodes (for patients >15 kg.), No Cable, Catalog Number 51-7410. Intended to be used for the dispersion and return to the electrosurgical generator.
Category
Medical Device
Distribution
45 states
SevereFDA (Devices)·Z-2354-2016·2016-08-31
Alere INRatio PT/INR System Recalled for Inaccurate Warfarin Monitoring Results
Alere San Diego is voluntarily recalling INRatio PT/INR Monitoring Systems because they may show lower INR values than central laboratory tests, potentially affecting warfarin dosing.
Product
Alere INRatio PT/INR System Professional Model Numbers: 0100004 Product Usage: Alere INRatio ¿ 2 PT/INR Monitoring System (Professional Use): The Alere INRatio ¿ 2 PT/INR Monitoring System (Professional Use), consisting of the INRatio ¿ 2 Monitor and INRatio¿ 2 PT/INR test…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2622-2016·2016-08-31
Cook Inc. Recalls Transluminal Biliary Biopsy Forceps Sets Due to Tip Fracture
Cook Inc. is recalling 2,606 Transluminal Biliary Biopsy Forceps Sets because polymer degradation can cause the catheter tip to fracture or separate, potentially leading to device fragments in the body.
Product
Transluminal Biliary Biopsy Forceps Set Forceps, Biopsy, Non-Electric Intended for access to and biopsy of tissue within the biliary ductal system
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2609-2016·2016-08-31
Baxter HomeChoice Peritoneal Dialysis Systems Recalled for Software Defect
Baxter is recalling HomeChoice and HomeChoice PRO automated peritoneal dialysis systems due to a software defect that may cause serious complications in patients with ascites.
Product
1) The HomeChoice automated peritoneal dialysis system. Dataplate located on the device is labeled in part: Baxter. 2) The HomeChoice PRO automated peritoneal dialysis system. Dataplate located on the device is labeled in part: Baxter. The HomeChoice/HomeChoice Pro…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2360-2016·2016-08-31
Alere INRatio2 PT/INR Monitoring System Recalled for Inaccurate INR Results
Alere San Diego is voluntarily recalling INRatio2 PT/INR Monitoring Systems because they may report inaccurate INR results, potentially leading to incorrect anticoagulant dosing.
Product
Alere INRatio2 PT/INR Professional Monitoring System Model Number: 55128A Product Usage: The Alere INRatio¿/INRatio¿2 system uses a modified version of the one-stage PT test. After a drop of blood is applied to the test strip, it is drawn into the test area and mixed with…
Category
Medical Device
Distribution
Distributed nationwide
SevereNHTSA·16V634000·2016-08-31
Daimler Trucks Recalls 2014-2017 Models Due to Front Axle Hub Failure Risk
Daimler Trucks North America is recalling specific 2014-2017 Freightliner and Western Star trucks because front axle hubs may fail, causing the wheel to separate from the axle.
Product
WESTERN STAR — WESTERN STAR, FREIGHTLINER 4800, 5700, 108SD, CASCADIA
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2362-2016·2016-08-31
Alere INRatio PT/INR Test Strips Recalled for Inaccurate Results
Alere San Diego is voluntarily recalling INRatio test strips because they may report inaccurate INR results, potentially affecting warfarin therapy.
Product
Alere INRatio/ INRatio2 PT/INR Test Strips Model Number: 99007EU, 99007G1, 99007G3, 99007G5, 99007G7, 99008EU, 99008G1, 99008G3, 99008G5, 99008G7 Product Usage: The Alere INRatio¿/INRatio¿2 system uses a modified version of the one-stage PT test. After a drop of blood is…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2619-2016·2016-08-31
Cook Inc. Recalls Neff DAgostino Percutaneous Access Sets Due to Tip Fracture
Cook Inc. is recalling 5,020 Neff DAgostino Percutaneous Access Sets because polymer degradation can cause the catheter tip to fracture or separate, potentially leading to device fragments in the body.
Product
Neff DAgostino Percutaneous Access 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 (Food)·F-1954-2016·2016-08-31
Northwest Wild Products Recalls Canned Fish and Razor Clams
Northwest Wild Products is recalling canned fish and razor clams with codes starting with OC due to potential Clostridium botulinum contamination.
Product
Columbia River Chinook Salmon -Custom Smoked, NW Wild Products, 6.5 oz. metal cans. No UPC
Category
Food
Distribution
1 state
SevereFDA (Food)·F-1965-2016·2016-08-31
Northwest Wild Products Recalls Canned Fish and Razor Clams for Botulism Risk
Northwest Wild Products is recalling canned fish and razor clams with codes starting with OC due to potential Clostridium botulinum contamination.
Product
Oregon Sardines - Custom Smoked-NW Wild Products, 6.5 oz. metal cans. No UPC
Category
Food
Distribution
1 state
SevereFDA (Drugs)·D-1467-2016·2016-08-31
Mylan Amlodipine Besylate Tablets Recalled for CGMP Deviations
Mylan Institutional, Inc. is recalling Amlodipine Besylate Tablets, 5 mg, because they were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Product
Amlodipine Besylate Tablets, USP, 5 mg*, packaged in a) 100-count (10 x 10) unit dose blisters per carton, NDC 51079-451-20; b) 300-count (10 x 30) unit dose blisters per carton, NDC 51079-451-56, c) 25-count (25 x 1) Robot-Rx Ready Packages in a carton, NDC 51079-451-19; and d)…
Category
Drug
Distribution
Distributed nationwide