Manufacturer

Genzyme Corporation, A Sanofi Company

18 recalls in our database name Genzyme Corporation, A Sanofi Company as the manufacturing or recalling firm.

What the numbers show

Total: 18
Critical: 0
Severe: 0
Most recent: 2013-09-11

Of the 18 recalls from Genzyme Corporation, A Sanofi Company we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–18 of 18

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. L
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-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 temp
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 tempo
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2145-2013·2013-09-11
Genzyme Recalls LeGoo Endovascular Occlusion Gel Due to Particulates
Genzyme is recalling LeGoo Endovascular Occlusion Gel because the product contains particulates (fibers). The recall covers 660 units distributed worldwide.
Product
LeGoo¿ Endovascular Occlusion Gel- 0.5 mL LeGoo with 3 Cannula Pouch Product Number: LG50 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 ves
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2154-2013·2013-09-11
Genzyme Recalls LeGoo Endovascular Occlusion Gel Due to Particulates
Genzyme is recalling 110 units of LeGoo Endovascular Occlusion Gel 0.5 mL because the product contains particulates (fibers). The recall covers all lot codes distributed worldwide.
Product
LeGoo Endovascular Occlusion Gel 0.5 mL Product Number: LG50IT 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-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 temp
Category
Medical Device
Distribution
Distributed nationwide
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 v
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 tem
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 v
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2155-2013·2013-09-11
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 220 units distributed worldwide.
Product
LeGoo Endovascular Occlusion Gel 1.0 mL Product Number: LG100IT 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-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 ve
Category
Medical Device
Distribution
Distributed nationwide
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. Le
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 tem
Category
Medical Device
Distribution
Distributed nationwide
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 ve
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 for
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 ves
Category
Medical Device
Distribution
Distributed nationwide