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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