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.

6276–6300 of 7443

CriticalFDA (Devices)·Z-1791-2013·2013-07-31
GE Healthcare Recalls Discovery NM 630 Nuclear Imaging Systems
GE Healthcare is recalling 108 Discovery NM 630 nuclear imaging systems worldwide due to a failure mode that can cause serious injury or death.
Product
Discovery NM 630, dual detector free-geometry integrated nuclear imaging system. Product Usage: The GE Discovery NM 630 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and in
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1793-2013·2013-07-31
GE Healthcare Recalls Optima NM/CT 640 Systems Due to Patient Death
GE Healthcare is recalling 25 Optima NM/CT 640 systems worldwide after a patient died from injuries sustained during a scan on a related system.
Product
Optima NM/CT 640 Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine (NM) system using a variety of scannin
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Food)·F-1737-2013·2013-07-31
Bergin Low Glycemic Snack Mix Recalled Due to Salmonella Risk
Bergin Fruit and Nut Company is recalling Low Glycemic Snack Mix products because pistachios used in manufacturing were supplied by a facility where Salmonella was detected.
Product
601180 LOW GLYCEMIC SNACK MIX 12/4 OZ BERGIN RED BAG, UPC 2052601180 601082 LOW GLYCEMIC SNACK MIX 12/8 CLAMSHELL, UPC 2052601082 601082.03 LOW GLYCEMIC SNACK MIX 12/8 CLAMSHELL KOWALSKI, UPC 2052601082 601080 LOW GLYCEMIC SNACK MIX 30#, UPC 2052601080 601084 LOW GLYC
Category
Food
Distribution
15 states
CriticalFDA (Devices)·Z-1761-2013·2013-07-31
LeMaitre Vascular Recalls AlboGraft Vascular Grafts Due to Surface Leaking
LeMaitre Vascular is recalling 3 units of AlboGraft Knitted with Collagen vascular grafts because they may leak blood from the surface after implantation.
Product
AlboGraft Knitted with Collagen, Straight 40x08 Catalog Number: AMC4008 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Category
Medical Device
Distribution
1 state
CriticalFDA (Food)·F-1740-2013·2013-07-31
Bergin Fruit and Nut Pistachio Recall Due to Salmonella Risk
Bergin Fruit and Nut is recalling raw pistachio products because Salmonella was found in the environment at the supplier, ARO Pistachio Inc.
Product
600943 PISTACHIOS KERNELS RAW 8/11 OZ SQ TUB, UPC 2052600943 601902 PISTACHIOS KERNELS RAW 10/14 OZ TAPE BAG, UPC 2052601902 601902.09 PISTACHIOS KERNELS RAW 10/14 OZ TAPE BAG BYERLYS, UPC 2052601902 600899 PISTACHIOS KERNELS RAW 30#, IUPAC 600901 PISTACHIOS KERNELS
Category
Food
Distribution
15 states
CriticalFDA (Food)·F-1742-2013·2013-07-31
Bergin Fruit and Nut Pistachios Recalled Due to Salmonella Risk
Bergin Fruit and Nut Co is recalling pistachio products because Salmonella was found in the environment at the supplier, ARO Pistachio Inc.
Product
603684 PISTACHIOS S/I/S 12/10 OZ GOLD BAG, UPC 2052603684 600913 PISTACHIOS S/I/S 12/12 OZ BAGLINE, UPC 2052600913 600913.11 PISTACHIOS S/I/S 12/12 OZ BAGLINE AMAZON, UPC 2052600913 600913.07 PISTACHIOS S/I/S 12/12 OZ BAGLINE DISPLAY BOX, UPC 2052600913 600923.05 PIST
Category
Food
Distribution
15 states
CriticalFDA (Devices)·Z-1787-2013·2013-07-31
GE Healthcare Recalls Infinia Hawkeye 4 Gamma Cameras Due to Patient Death
GE Healthcare is recalling Infinia Hawkeye 4 Nuclear Medicine Systems after a patient died from injuries sustained during a scan at a US VA Medical Center.
Product
GE Healthcare Infinia Hawkeye 4 Option For Dual-Head Variable Angle Gamma Camera, Hawkeye Option for Dual-Head Variable Angle Gamma Camera (this includes GE Quasar Nuclear Medicine Systems). Nuclear Medicine Systems Infinia devices Product Usage: The intended use of the Qua
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1757-2013·2013-07-31
LeMaitre Recalls AlboGraft Vascular Grafts Due to Blood Leakage
LeMaitre Vascular is recalling 3 units of AlboGraft Knitted with Collagen, Bifurcate 18x09 due to blood blushing or leaking from the graft surface after implantation.
Product
AlboGraft Knitted with Collagen, Bifurcate 18x09 Catalog Number: AMC1809 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Category
Medical Device
Distribution
1 state
CriticalFDA (Devices)·Z-1765-2013·2013-07-31
LeMaitre AlboGraft Vascular Grafts Recalled for Surface Leakage
LeMaitre Vascular is recalling 2 units of AlboGraft Woven with Collagen, Straight 15x26 (Lot 56890A) because blood blushing or leaking was observed from the graft surface after implantation.
Product
AlboGraft Woven with Collagen, Straight 15x26 Catalog Number: ATC1526 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Category
Medical Device
Distribution
1 state
CriticalFDA (Devices)·Z-1789-2013·2013-07-31
GE Healthcare Recalls Elscint APEX Helix Gamma Cameras Due to Patient Death
GE Healthcare is recalling 50 Elscint APEX Helix gamma cameras worldwide after a patient died from injuries sustained during a scan at a US VA Medical Center.
Product
Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring, digital gamma camera Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of sc
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Food)·F-1739-2013·2013-07-31
Bergin Pistachio Products Recalled Due to Salmonella Risk
Bergin Fruit and Nut Company is recalling specific pistachio products because Salmonella was found in the environment at the supplier, ARO Pistachio Inc.
Product
601911 PISTACHIO KERNELS HOT & SPICY 30#, UPC 2052601911 601913 PISTACHIOS HOT AND SPICY 12/5 OZ BERGIN RED BAG, UPC 2052601913
Category
Food
Distribution
15 states
CriticalFDA (Food)·F-1741-2013·2013-07-31
Bergin Fruit and Nut Pistachio Products Recalled Due to Salmonella Risk
Bergin Fruit and Nut Co is recalling pistachio products because Salmonella was found in the environment at the supplier, ARO Pistachio Inc.
Product
600908.03 PISTACHIOS KERNELS R/S 12/16 OZ TRAY KOWALSKI, UPC 2052600908 600909 PISTACHIOS KERNELS R/S 16/7 OZ CLAMSHELL, UPC 2052600909 600909.03 PISTACHIOS KERNELS R/S 16/7 OZ CLAMSHELL KOWALSKI, IUPAC 600904 PISTACHIOS KERNELS R/S 30#, UPC 2052600904 600905 PISTAC
Category
Food
Distribution
15 states
CriticalFDA (Food)·F-1744-2013·2013-07-31
High Quality Organics Recalls Dried Oregano Due to Salmonella Risk
High Quality Organics is recalling dried oregano sold in 25 lb boxes because a customer's test found Salmonella in the product.
Product
Dried Oregano, cut and sifted; Organic; Product of Turkey, sold in 25 lb boxes High Quality Organics, Reno, NV
Category
Food
Distribution
3 states
CriticalFDA (Devices)·Z-1792-2013·2013-07-31
GE Healthcare Recalls Nuclear Medicine Imaging Systems Due to Patient Death
GE Healthcare is recalling 213 Discovery NM/CT 670 systems worldwide after a patient died from injuries sustained during a scan on a related system.
Product
Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system. Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1788-2013·2013-07-31
GE Healthcare Recalls Nuclear Medicine Imaging Systems Due to Patient Death
GE Healthcare is recalling Varicam/VG and VG Hawkeye devices after a patient died from injuries sustained during a scan at a US VA Medical Center.
Product
GE Healthcare Varicam/VG and VG Hawkeye devices Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by vario
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1770-2013·2013-07-31
LeMaitre Recalls AlboGraft Vascular Grafts Due to Surface Bleeding
LeMaitre Vascular is recalling 3 units of AlboGraft Woven with Collagen, Straight 30x26 (Lot 56890A) because blood blushing or leaking was observed from the graft surface after implantation.
Product
AlboGraft Woven with Collagen, Straight 30x26 Catalog Number: ATC3026 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Category
Medical Device
Distribution
1 state
CriticalFDA (Devices)·Z-1756-2013·2013-07-31
LeMaitre Recalls Albo Graft Vascular Implants Due to Surface Leaking
LeMaitre Vascular is recalling 7 units of Albo Graft Knitted with Collagen, Bifurcate 16x08 due to blood blushing or leaking from the graft surface after implantation.
Product
Albo Graft Knitted with Collagen, Bifurcate 16x08 Catalog Number: AMC1608 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Category
Medical Device
Distribution
1 state
CriticalFDA (Devices)·Z-1790-2013·2013-07-31
GE Healthcare Recalls Nuclear Medicine Imaging Systems Due to Patient Death
GE Healthcare is recalling 13 Brivo NM615 nuclear medicine imaging systems worldwide after a patient died from injuries sustained during a scan on a related system.
Product
Brivo NM615, is an all-purpose, single detector integrated nuclear imaging system. Product Usage: The Brivo NM 615 is an emission computed tomography system intended to detect the location and distribution of gamma ray photon emitting radionuclides in the body and to produc
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Food)·F-1743-2013·2013-07-31
Bergin Fruit and Nut Recalls Raw Pistachios Due to Salmonella Risk
Bergin Fruit and Nut Co Inc is recalling raw pistachios because Salmonella was found in the environment at the supplier, ARO Pistachio Inc.
Product
600910 PISTACHIOS SPLITS RAW 30#, UPC 2052600910
Category
Food
Distribution
15 states
CriticalFDA (Drugs)·D-810-2013·2013-07-31
Med Prep Consulting Recalls Magnesium Sulfate Injection Bags Due to Mold
Med Prep Consulting is recalling 403,883 bags of Magnesium Sulfate 2 grams in Dextrose 5% for Injection due to non-sterility and mold contamination.
Product
Magnesium Sulfate 2 grams in Dextrose 5% for Injection, in 50 mL Plastic Infusion Bags, Med Prep Consulting Inc., Tinton Falls, NJ 07712
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Food)·F-1736-2013·2013-07-31
Bergin Fruit and Nut Recalls Pistachio Products Due to Salmonella Risk
Bergin Fruit and Nut Co Inc is recalling pistachio products because Salmonella was found in the environment at the supplier, ARO Pistachio Inc.
Product
604320 LOW GLYCEMIC INSTANT OATMEAL 25#, UPC 2052604320
Category
Food
Distribution
15 states
CriticalFDA (Food)·F-1713-2013·2013-07-24
Fresh Unlimited Broccoli Salad Kit Recalled for Listeria Contamination
Fresh Unlimited Inc is recalling Broccoli Salad Kits because a supplier's sunflower raisin mix packets were contaminated with Listeria monocytogenes.
Product
Broccoli Salad Kit with Dressing; packaged in plastic bags inside paper cartons, 5 bags per case.
Category
Food
Distribution
6 states
CriticalFDA (Food)·F-1712-2013·2013-07-24
Fresh Unlimited Broccoli Salad Kit Recalled for Listeria Contamination
Fresh Unlimited Inc is recalling Broccoli Salad Kit No Dressing, No Bacon because a supplier's sunflower raisin mix was contaminated with Listeria monocytogenes.
Product
Broccoli Salad Kit No Dressing, No Bacon; packaged in plastic bags inside paper cartons, 4 bags per case.
Category
Food
Distribution
6 states
CriticalFDA (Devices)·Z-1690-2013·2013-07-24
Codman MedStream Infusion Pump Recalled for Miscalibrated Fill Level Sensor
Codman & Shurtleff is recalling MedStream Programmable Infusion Pumps because a miscalibrated fill level sensor may affect dosing levels.
Product
MedStream Programmable Infusion Pump- Implantable for the intrathecal delivery of Baclofen or Morphine Product Code:91-4200 (20ml pump) US 91-4200. Intended for the intrathecal delivery of Baclofen or Morphine.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Food)·F-1720-2013·2013-07-24
Windy Acres Recalls Sunflower Kernel and Raisin Mix for Listeria Risk
Windy Acres Candy & Nut is recalling a raw sunflower kernel and dark raisin mix because the supplier reported potential Listeria monocytogenes contamination.
Product
RAW SUNFLOWER KERNEL, DARK RAISIN 50/50 MIX 24/l0 oz packaged in clear plastic wrap.
Category
Food
Distribution
1 state