Manufacturer

Cook, Inc.

264 recalls in our database name Cook, Inc. as the manufacturing or recalling firm.

What the numbers show

Total: 264
Critical: 5
Severe: 51
Most recent: 2021-12-29

Of the 264 recalls from Cook, Inc. we have scored against our rubric, 5 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 51 (19%) 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.

176–200 of 264

HighFDA (Devices)·Z-1188-2018·2018-04-04
Cook Inc. Recalls IVF Embryo Transfer Sets Due to Quality Testing Gaps
Cook Inc. is recalling specific lots of IVF embryo transfer sets and catheters because they were distributed without completed quality testing, posing a risk of nonviable gametes or embryos.
Product
1. SMS Embryo Transfer Set, Catalog Number: K-J-SMS-571800, Global Product Number: G19182; 2. Guardia" Access Nano Embryo Transfer Catheter, Catalog Number: K-JETS-551910-L, Global Product Number: G24215; 3. Sydney IVF¿ Embryo Transfer Set, Product Number: K-JETS-7019-SIVF, Globa
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1187-2018·2018-04-04
Cook Inc. Recalls Marrs Laparoscopic GIFT Catheters Due to Quality Testing Gaps
Cook Inc. is recalling 21 Marrs Laparoscopic GIFT Catheters because they were distributed without completed quality testing, posing a risk of nonviable embryos.
Product
Marrs Laparoscopic GIFT Catheters, Catalog Number:K-J-MLC-503000, Global Product Number: G18022 Product Usage: Used to place in vitro fertilized (IVF) embryos into the uterine cavity. Intended for one-time use
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1186-2018·2018-04-04
Cook Inc. Recalls IVF Intratubal Transfer Sets Due to Quality Testing Gaps
Cook Inc. is recalling specific lots of Echosight Jansen-Anderson Intratubal Transfer Sets because they were distributed without completed quality testing, posing a risk of nonviable embryos.
Product
Echosight Jansen-Anderson Intratubal Transfer Set, Catalog Number: K-J-JITS-572900, Global Product Number: G17946 Product Usage: Used to place in vitro fertilized (IVF) embryos into the uterine cavity. Intended for one-time use
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0960-2018·2018-03-21
Cook Inc. Newton Wire Guide Recalled for Missing Heparin Labeling
Cook Inc. is recalling Newton Wire Guides because the labels do not state that the product is heparin-coated.
Product
Newton Wire Guide
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0954-2018·2018-03-21
Cook Inc. Recalls Coons Interventional Wire Guide Due to Labeling Error
Cook Inc. is recalling 3,369 Coons Interventional Wire Guides because the label fails to state that the product is heparin-coated.
Product
Coons Interventional Wire Guide
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0966-2018·2018-03-21
Cook Inc. Recalls Femoral Artery Pressure Monitoring Sets for Labeling Error
Cook Inc. is recalling 266 femoral artery pressure monitoring sets because the labels fail to state that the product is heparin-coated.
Product
Femoral Artery Pressure Monitoring Set
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0955-2018·2018-03-21
Cook Inc. Recalls Disposable Reuter Tip Deflecting Wire Guides for Labeling Error
Cook Inc. is recalling 18,398 units of Disposable Reuter Tip Deflecting Wire Guides because the labels fail to state that the product is heparin-coated.
Product
Disposable Reuter Tip Deflecting Wire Guide
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0957-2018·2018-03-21
Cook Inc. Recalls Fixed Core Bentson Devices Due to Labeling Error
Cook Inc. is recalling 2,210 Fixed Core Bentson devices because the labels fail to state that the product is heparin-coated.
Product
Fixed Core Bentson
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0963-2018·2018-03-21
Cook Inc. Recalls TFE Coated Curved Newton LLT Due to Labeling Error
Cook Inc. is recalling 3,364 units of TFE Coated Curved Newton LLT because the label fails to state that the product is heparin-coated.
Product
TFE Coated Curved Newton LLT
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0962-2018·2018-03-21
Cook Inc. Recalls Rosen Curved Wire Guides Due to Labeling Error
Cook Inc. is recalling Rosen Curved Wire Guides because the labels fail to state that the product is heparin-coated.
Product
Rosen Curved Wire Guide
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0961-2018·2018-03-21
Cook Inc. Recalls Reuter Tip Deflecting Wire Guide for Labeling Error
Cook Inc. is recalling 55 Reuter Tip Deflecting Wire Guides because the labels fail to state that the product is heparin-coated.
Product
Reuter Tip Deflecting Wire Guide
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0948-2018·2018-03-21
Cook Inc. Recalls Amplatz Extra Stiff Wire Guide Due to Labeling Error
Cook Inc. is recalling 129,727 Amplatz Extra Stiff Wire Guides because the label fails to state that the product is heparin-coated.
Product
Amplatz Extra Stiff Wire Guide
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0956-2018·2018-03-21
Cook Inc. Recalls Double Flexible Tipped Wire Guides Due to Labeling Error
Cook Inc. is recalling 10,367 Double Flexible Tipped Wire Guides because the labels fail to state that the product is heparin-coated.
Product
Double Flexible Tipped Wire Guide
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0959-2018·2018-03-21
Cook Inc. Recalls Movable Core Wire Guide Due to Labeling Error
Cook Inc. is recalling 21,913 Movable Core Wire Guides because the labels failed to state that the products are heparin-coated.
Product
Movable Core Wire Guide
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0947-2018·2018-03-21
Cook Inc. Recalls Amplatz Extra Stiff Whisker Wire Guide for Labeling Error
Cook Inc. is recalling 648 Amplatz Extra Stiff Whisker Wire Guides because the labels fail to state that the product is heparin-coated.
Product
Amplatz Extra Stiff Whisker Wire Guide
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0950-2018·2018-03-21
Cook Inc. Recalls Amplatz Ultra Stiff Wire Guide Due to Labeling Error
Cook Inc. is recalling 12,462 Amplatz Ultra Stiff Wire Guides because the label fails to state that the product is heparin-coated.
Product
Amplatz Ultra Stiff Wire Guide
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0951-2018·2018-03-21
Cook Inc. Recalls Bentson Cerebral Wire Guide Due to Labeling Error
Cook Inc. is recalling 45 Bentson Cerebral Wire Guides because the labels fail to state that the product is heparin-coated.
Product
Bentson Cerebral Wire Guide
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0964-2018·2018-03-21
Cook Inc. Recalls Central Venous Catheter Trays Due to Labeling Error
Cook Inc. is recalling 13 Central Venous Catheter Trays because the label fails to state that the product is heparin-coated.
Product
Central Venous Catheter Tray
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0949-2018·2018-03-21
Cook Inc. Recalls Amplatz Stiff Wire Guide Due to Labeling Error
Cook Inc. is recalling 32,340 Amplatz Stiff Wire Guides because the labels fail to state that the product is heparin-coated.
Product
Amplatz Stiff Wire Guide
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0965-2018·2018-03-21
Cook Inc. Recalls Left Atrial Catheter Sets Due to Labeling Error
Cook Inc. is recalling 56 Left Atrial Catheter Sets because the labels failed to state that the product is heparin-coated.
Product
Left Atrial Catheter Set
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0953-2018·2018-03-21
Cook Inc. Recalls Bentson Wire Guides Due to Missing Heparin Labeling
Cook Inc. is recalling Bentson Wire Guides because the labels fail to state that the product is heparin-coated.
Product
Bentson Wire Guide
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0952-2018·2018-03-21
Cook Inc. Recalls Bentson Plus Wire Guide Due to Labeling Error
Cook Inc. is recalling the Bentson Plus Wire Guide because the label fails to state that the product is heparin-coated.
Product
Bentson Plus Wire Guide
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0958-2018·2018-03-21
Cook Inc. Recalls Fixed Core Wire Guide Due to Heparin Labeling Error
Cook Inc. is recalling 601,778 Fixed Core Wire Guides because the labels failed to state that the products are heparin-coated.
Product
Fixed Core Wire Guide
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0830-2018·2018-03-07
Cook Inc. Recalls Percutaneous Gastrostomy Sets Due to Wire Guide Defect
Cook Inc. is recalling 615 units of Mallinckrodt Institute Percutaneous Gastrostomy Sets because wire guides may be loaded backwards into the holder.
Product
Mallinckrodt Institute Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0832-2018·2018-03-07
Cook Recalls Wills-Oglesby Percutaneous Gastrostomy Sets Due to Wire Guide Defect
Cook Inc. is recalling Wills-Oglesby Percutaneous Gastrostomy Sets because wire guides may be loaded backwards into the holder.
Product
Wills-Oglesby Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding
Category
Medical Device
Distribution
Distributed nationwide