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Cook Biotech, Inc.

Complete recall history across all FDA and CPSC categories — 15 total recalls

Cook Biotech, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (15)

FDA medical device enforcement actions by Cook Biotech, Inc.

Date Product Reason Class
Nov 22, 2024 Cook Medical Biodesign Dural Graft, REF C-DUR-7X10, REF G31091, Sterile Incorrect version of IFU was used rather than updated version; and incorrect ... Class II
Nov 22, 2024 Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, RE... Incorrect version of IFU was used rather than updated version; and incorrect ... Class II
Nov 22, 2024 Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Ste... Incorrect version of IFU was used rather than updated version; and incorrect ... Class II
Aug 7, 2024 Biodesign Fistula Plug C-FPS-0.4 - For implantation to reinforce soft tissue ... Products expire prior to the expiration date printed on the product labeling Class II
Aug 7, 2024 Biodesign Fistula Plug C-FPS-0.7 - For implantation to reinforce soft tissue ... Products expire prior to the expiration date printed on the product labeling Class II
Aug 7, 2024 Biodesign Recto-Vaginal Fistula Plug RVP-0.4 - For implantation to reinforce ... Products expire prior to the expiration date printed on the product labeling Class II
Aug 7, 2024 Biodesign Fistula Plug C-FPS-0.2-2 - For implantation to reinforce soft tissu... Products expire prior to the expiration date printed on the product labeling Class II
Aug 7, 2024 Biodesign Fistula Plug C-FPB-0.4 - For implantation to reinforce soft tissue ... Products expire prior to the expiration date printed on the product labeling Class II
Aug 7, 2024 Biodesign Fistula Plug C-FPS-0.4-2 - For implantation to reinforce soft tissu... Products expire prior to the expiration date printed on the product labeling Class II
Aug 7, 2024 Biodesign Fistula Plug C-FPS-0.2 - For implantation to reinforce soft tissue ... Products expire prior to the expiration date printed on the product labeling Class II
Aug 7, 2024 Biodesign Recto-Vaginal Fistula Plug RVP-0.7 - For implantation to reinforce ... Products expire prior to the expiration date printed on the product labeling Class II
Aug 7, 2024 Biodesign Fistula Plug C-FPS-0.7-2 - For implantation to reinforce soft tissu... Products expire prior to the expiration date printed on the product labeling Class II
Aug 7, 2024 Biodesign Recto-Vaginal Fistula Plug RVP-0.2 - For implantation to reinforce ... Products expire prior to the expiration date printed on the product labeling Class II
Aug 7, 2024 Biodesign Fistula Plug C-FPB-0.7 - For implantation to reinforce soft tissue ... Products expire prior to the expiration date printed on the product labeling Class II
Aug 7, 2024 Biodesign Inguinal Hernia Graft C-IHM-10X15 - To reinforce soft tissues in th... Products expire prior to the expiration date printed on the product labeling Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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