Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

37501–37525 of 40325

HighFDA (Devices)·Z-2144-2013·2013-09-11
Genzyme Recalls LeGoo Endovascular Occlusion Gel Due to Particulates
Genzyme is recalling LeGoo Endovascular Occlusion Gel because the product contains particulates (fibers). The recall affects 250 units distributed worldwide.
Product
LeGoo¿ Endovascular Occlusion Gel-2.5 mL LeGoo w/ no Cannula Product Number: PV-250 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel.…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2149-2013·2013-09-11
Genzyme Recalls LeGoo Internal Vessel Occluder Due to Fiber Particulates
Genzyme Corporation is recalling 776 units of LeGoo Internal Vessel Occluder because the product contains particulates (fibers). The recall covers units distributed worldwide.
Product
LeGoo Internal Vessel Occluder .5mL Product Number: 10-0050 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2152-2013·2013-09-11
Genzyme Recalls LeGoo Internal Vessel Occluder Due to Fiber Particulates
Genzyme is recalling LeGoo Internal Vessel Occluder 5mL units because they contain fiber particulates. The recall covers 308 units distributed worldwide.
Product
LeGoo Internal Vessel Occluder 5mL Product Number: 10-0500 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2148-2013·2013-09-11
Genzyme Recalls LeGoo Internal Vessel Occluder Due to Particulates
Genzyme is recalling LeGoo Internal Vessel Occluder devices because they contain particulates (fibers). The recall affects 448 units distributed worldwide.
Product
LeGoo Internal Vessel Occluder .25mL Product Number: 10-0025 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2158-2013·2013-09-11
MicroAire Steinmann Pins Recalled Due to Potential Sterility Compromise
MicroAire Surgical Instruments is recalling Steinmann Pins because defective pouch seals may compromise sterility. The recall affects 15,786 units distributed worldwide.
Product
Steinmann Pin, packed in a clear tube with end caps, tubes packed in a sterile barrier pouch, 6 pouches/sales unit. Pouches are labeled in part ***MicroAire Surgical Instruments 3590 Grand Forks Blvd Charlottesville, VA LLC 22911*** Models: 1620-109 1636-509…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2140-2013·2013-09-11
Genzyme Recalls LeGoo Endovascular Occlusion Gel Due to Particulates
Genzyme Corporation is recalling 65 units of LeGoo Endovascular Occlusion Gel because the product contains particulates (fibers). The recall covers lots distributed worldwide.
Product
LeGoo¿ Endovascular Occlusion Gel-0.5 mL LeGoo with 3 Cannula Pouch Product Number: CS-50 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2150-2013·2013-09-11
Genzyme Recalls LeGoo Internal Vessel Occluder Due to Particulates
Genzyme Corporation is recalling 652 units of LeGoo Internal Vessel Occluder because the product contains particulates (fibers). The recall covers units distributed worldwide.
Product
LeGoo Internal Vessel Occluder 1mL Product Number: 10-0100 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2153-2013·2013-09-11
Genzyme Recalls LeGoo Internal Vessel Occluder Due to Particulates
Genzyme Corporation is recalling 37 units of LeGoo Internal Vessel Occluder 10mL because the product contains particulates (fibers). The recall covers units distributed worldwide.
Product
LeGoo Internal Vessel Occluder 10mL Product Number: 10-1000 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2159-2013·2013-09-11
MicroAire Kirschner-Wire Recall Due to Defective Sterile Pouch Seals
MicroAire Surgical Instruments is recalling Kirschner-Wires because defective pouch seals may compromise sterility. The recall affects 15,786 units distributed worldwide.
Product
Kirschner-Wire (K-Wire), packed in a clear tube with end caps, tubes packed in a sterile barrier pouch, 6 pouches/sales unit. Pouches are labeled in part ***MicroAire Surgical Instruments 3590 Grand Forks Blvd Charlottesville, VA LLC 22911*** Models: 1620-109…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2134-2013·2013-09-11
DePuy Spine Recalls Confidence Spinal Cement System Kits
DePuy Spine is recalling Confidence Spinal Cement System Kits because hydraulic pump leaks can cause loss of pressure during cement injection.
Product
CONFIDENCE SPINAL CEMENT SYSTEM KIT, Product Code: 2839-13-000 The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or…
Category
Medical Device
Distribution
33 states
HighFDA (Devices)·Z-2147-2013·2013-09-11
Genzyme Recalls LeGoo Endovascular Occlusion Gel Due to Particulates
Genzyme Corporation is recalling 181 units of LeGoo Endovascular Occlusion Gel because the product contains particulates (fibers). The recall covers all lot codes distributed worldwide.
Product
LeGoo¿ Endovascular Occlusion Gel-2.5 mL LeGoo with 1 Cannula Pouch Product Number: LG250 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2135-2013·2013-09-11
Siemens Recalls ADVIA Chemistry A1c_3 Calibrators Due to Positive Bias
Siemens Healthcare Diagnostics is recalling ADVIA Chemistry A1c_3 Calibrators because they cause a positive bias of up to 12% in HbA1c test results.
Product
ADVIA Chemistry A1c_3 Calibrators, Catalog Number 10491408, IVD --- COMMON/USUAL NAME: ADVIA Chemistry A1c_3 Calibrators Shipping or unit package: Level 1: 2 x 0.5 g; Level 2: 2 x 0.5 g; Level 3: 2 x 0.5 g; Level 4: 2 x 0.5 g -- Siemens Healthcare Diagnostics, Inc. Tarrytown…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2141-2013·2013-09-11
Genzyme Recalls LeGoo Endovascular Occlusion Gel Due to Particulates
Genzyme Corporation is recalling LeGoo Endovascular Occlusion Gel because the product contains particulates (fibers). The recall covers 100 units distributed worldwide.
Product
LeGoo¿ Endovascular Occlusion Gel-1.0 mL LeGoo with 3 Cannula Pouch Product Number: CS-100 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2151-2013·2013-09-11
Genzyme Recalls LeGoo Internal Vessel Occluder Due to Particulates
Genzyme Corporation is recalling 331 units of LeGoo Internal Vessel Occluder 2.5mL because the product contains particulates (fibers). The recall covers units distributed worldwide.
Product
LeGoo Internal Vessel Occluder 2.5mL Product Number: 10-0250 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2143-2013·2013-09-11
Genzyme Recalls LeGoo Endovascular Occlusion Gel Due to Particulates
Genzyme is recalling 45 units of LeGoo Endovascular Occlusion Gel because the product contains particulates (fibers). The recall covers all lot codes distributed worldwide.
Product
LeGoo¿ Endovascular Occlusion Gel- 1.0 mL LeGoo w/ no Cannula Product Number: PV-100 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel.…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2132-2013·2013-09-11
DePuy Spine Recalls Confidence Spinal Cement System 5cc Kits
DePuy Spine is recalling Confidence Spinal Cement System 5cc kits because hydraulic pump leaks can cause loss of pressure during injection.
Product
CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT, Product Code: 2839-05-000 The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or…
Category
Medical Device
Distribution
33 states
HighFDA (Devices)·Z-2157-2013·2013-09-11
Elekta Recalls DMLC IV-ERGO Beam Shaping Blocks for Radiation Therapy
Elekta, Inc. is recalling 31 DMLC IV-ERGO beam shaping blocks used in radiation therapy due to potential clinical mistreatment from workflow errors or incorrect settings.
Product
DMLC IV-ERGO - Beam shaping block for Radiation Therapy.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2142-2013·2013-09-11
Genzyme Recalls LeGoo Endovascular Occlusion Gel Due to Particulates
Genzyme Corporation is recalling LeGoo Endovascular Occlusion Gel because the product contains particulates (fibers). The recall affects 5 units distributed worldwide.
Product
LeGoo¿ Endovascular Occlusion Gel-0.5 mL LeGoo w/ no Cannula Product Number: PV-50 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel.…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2139-2013·2013-09-11
Genzyme Recalls LeGoo Endovascular Occlusion Gel Due to Particulates
Genzyme is recalling LeGoo Endovascular Occlusion Gel because the product contains particulates (fibers). The recall affects 30 units distributed worldwide.
Product
LeGoo¿ Endovascular Occlusion Gel-0.25 mL LeGoo with 3 Cannula Pouch Product Number: CS-25 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2133-2013·2013-09-11
DePuy Spine Recalls Confidence Spinal Cement System Due to Pump Leak
DePuy Spine is recalling the Confidence Spinal Cement System 11CC Plus Kit because water leaks in the hydraulic pump cause pressure loss, preventing cement injection.
Product
CONFIDENCE SPINAL CEMENT SYSTEM 11CC PLUS KIT, Product Code: 2839-10-000 The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during…
Category
Medical Device
Distribution
33 states
ModerateFDA (Devices)·Z-2137-2013·2013-09-11
Boston Scientific Recalls Small Peripheral Cutting Balloon Catheters
Boston Scientific is recalling 4.0mm x 15mm Small Peripheral Cutting Balloon catheters because users may be unable to remove the protector cap from the device.
Product
Boston Scientific, Small Peripheral Cutting BalloonTM, Sterilized using irradiation: The Peripheral Cutting Balloon Catheters are indicated for Percutaneous Transluminal Angioplasty (PTA) of obstructive lesions of synthetic or native arteriovenous dialysis fistulae. 1)…
Category
Medical Device
Distribution
43 states
ModerateFDA (Devices)·Z-2146-2013·2013-09-11
Genzyme Recalls LeGoo Endovascular Occlusion Gel Due to Particulates
Genzyme Corporation is recalling 994 units of LeGoo Endovascular Occlusion Gel because the product contains particulates (fibers). The recall covers units distributed worldwide.
Product
LeGoo¿ Endovascular Occlusion Gel- 1.0 mL LeGoo with 3 Cannula Pouch Product Number: LG100 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2156-2013·2013-09-11
Genzyme Recalls LeGoo Endovascular Occlusion Gel Due to Particulates
Genzyme Corporation is recalling LeGoo Endovascular Occlusion Gel 2.5 mL because the product contains particulates (fibers). The recall covers 100 units distributed worldwide.
Product
LeGoo Endovascular Occlusion Gel 2.5 mL Product Number: LG250IT LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2138-2013·2013-09-11
Boston Scientific Recalls 4.0mm Flextome Cutting Balloon Devices
Boston Scientific is recalling 4.0mm x 15mm Flextome Cutting Balloon devices because users may be unable to remove the protector cap.
Product
Boston Scientific, FlextomeTM Cutting BalloonTM, Sterilized using irradiation: 1) 4.00mm x 15mm FlextomeTM Cutting BalloonTM MonorailTM Microsurgical Dilatation Device, UPN #H749CBM3400150 Catalogue # CBM340015 & UPN# H749RB4400150 Catalogue # RB440015 2) 4.00mm x 15mm…
Category
Medical Device
Distribution
43 states
LowFDA (Devices)·Z-2131-2013·2013-09-11
Copan WASP Instrument Recalled for Software Upgrade to Prevent Table Rotation
Copan Italia is recalling 63 WASP instruments to upgrade software and eliminate a very low risk of the broth table rotating while the door is open.
Product
WASP (Walk Away Specimen Process). Automatic Planting and Streaking Instrument Catalog number: W086 WASP is a fully automated system used to process microbiological specimens in liquid phase for the investigation of infectious microbes.
Category
Medical Device
Distribution
2 states

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37501–37525 of 40325