Greatbatch Medical

Complete recall history across all FDA and CPSC categories — 16 total recalls

Greatbatch Medical 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 (16)

FDA medical device enforcement actions by Greatbatch Medical

Date Product Reason Class
Apr 23, 2017 Linear Straight Broach Handle (Rasp Handle) (Greatbatch Part # 510397; DJO Su... Greatbatch Medical has voluntarily initiated a Recall for the Linear Straight... Class II
Feb 15, 2017 Biosense Webster MobiCath Bi-Directional Guiding Sheath, Model D140010 (small... One side of the MobiCath Bi-Directional Guiding Sheath pouch may not be sealed. Class II
Nov 11, 2016 ViaPeel PTFE Peelable Introducer 5FR, Part Number 10890-006 Greatbatch received complaints with the ViaPeel Introducer Sheath 5FR, of han... Class II
Oct 19, 2016 Offset Reamer Handle, T5766 Product Usage: The reamer handles are re-usab... On June 14, 2016, Greatbatch discovered a significant increase in the number ... Class II
Sep 8, 2016 Greatbatch Stiffer Coaxial Micro-Introducer. Model #/ Name: 10904-001 Stiffer... Greatbatch Medical has identified an issue with the Stiffer Coaxial Micro-Int... Class II
Aug 2, 2016 Greatbatch, Offset Cup Impactor with the following Parts and Catalogue #: T... On December 17, 2015, Greatbatch discovered that the Standard Offset Cup Impa... Class I
Apr 26, 2016 Torque Limiting Adapter: Torque Limiting Attachment, Non Sterile, Distribute... Greatbatch Medical has initiated a global Field Recall for Torque Limiting D... Class II
Apr 26, 2016 Torque Limiting Handle: PRECIMED, T-Handle Torque, Non Sterile. Handle: ... Greatbatch Medical has initiated a global Field Recall for Torque Limiting D... Class II
Apr 26, 2016 Torque Limiting Screwdriver: Greatbatch Medical, Torque Limiting Driver, N... Greatbatch Medical has initiated a global Field Recall for Torque Limiting D... Class II
Apr 28, 2014 Coaxial Micro-Introducer Kit. Greatbatch Part Number/Bard Access Systems O... Greatbatch identified that the documentation does not support the five-year s... Class II
Jan 31, 2014 Greatbatch Medical, Offset Cup Impactor. Part Numbers: P9485, T10243, T1028... Greatbatch Medical has initiated a global Field Corrective Action for the Sta... Class I
May 31, 2013 Cordis a Johnson & Johnson Company, RadialSource Spring Wire Transradial Acce... Cordis Corporation, Inc and Greatbatch Medical are recalling one lot of the c... Class II
Jan 16, 2013 45¿ Angle Driver / Z-H, Greatbatch Medical 10 000 Wahrie Drive, Clarance, NY ... Greatbatch Medical has initiated a global voluntary recall and market withdra... Class II
Nov 12, 2012 Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog... Greatbatch Medical observed some anomalies of the inner lumen of the MobiCath... Class II
Sep 24, 2012 Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog... We are notifying you of a potential interaction between therapeutic catheters... Class II
Sep 6, 2012 Boston Scientific, Z Flex 270, Steerable Sheath, Sterile EO, Rx only, Distri... During the investigation of four returned Z Flex 270 Steerable Sheaths that w... 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.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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