Medtronic

Complete recall history across all FDA and CPSC categories — 47 total recalls

Medtronic 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 (47)

FDA medical device enforcement actions by Medtronic

Date Product Reason Class
May 3, 2017 Sutures. POLYSORB: POLSORB 0 18 U/D PRECUT 126R, Item Number: L4; POLSORB 0 ... Potential for an incomplete seal on the inner package, which may result in pr... Class II
May 3, 2017 Sutures. MAXON: MAXON 4/0 5X18" GREEN CV-24 D-TACH; Item Number: 8886621933;... Potential for an incomplete seal on the inner package, which may result in pr... Class II
May 3, 2017 USPACK-SUTURE KIT; Item Number: US1672 Potential for an incomplete seal on the inner package, which may result in pr... Class II
May 3, 2017 Best Practice Kit, Item Numbers: 00Z2064, 00Z2150, 00Z2190, 00Z2192, 00Z2211,... Potential for an incomplete seal on the inner package, which may result in pr... Class II
May 3, 2017 Sutures. ENDO STITCH: ENDO STITCH POLYSORB 0 48" U/D DLU SU, Item Number: 17... Potential for an incomplete seal on the inner package, which may result in pr... Class II
May 3, 2017 Sutures. BIOSYN: BIOSYN 4/0 18" VIOLET CV-25 DT, Item Number: GMJ34M Potential for an incomplete seal on the inner package, which may result in pr... Class II
May 3, 2017 CUSTOM SUTURE PACK; Item Number: US1540 and US1614 Potential for an incomplete seal on the inner package, which may result in pr... Class II
May 3, 2017 SCHRITTMACHER ANGIO X3; Item Number: 4045255423347 Potential for an incomplete seal on the inner package, which may result in pr... Class II
Feb 8, 2017 BNX Fine Need Aspiration System (22GA); Material/Part#: DSN-22-01 Handle may break during use. Class II
Feb 8, 2017 SharkCore LG Fine Needle Biopsy System (19GA); Material/Part#: DSL-19-01 Handle may break during use. Class II
Feb 8, 2017 SharkCore Fine Needle Biopsy System (25GA); Material/Part#: DSC-25-01 Handle may break during use. Class II
Feb 8, 2017 SharkCore Fine Needle Biopsy System (22 GA); Material/Part #s: DSC-22-01 Handle may break during use. Class II
Feb 8, 2017 BNX Fine Need Aspiration System (19GA); Material/Part #: DSN-19-01 Handle may break during use. Class II
Oct 4, 2016 Covidien Clearify Visualization System Item Code: 21-345 Intended to be us... Product sterility is compromised due to breach of the sterile barrier Class II
Oct 4, 2016 Best Practices kits containing certain production lots of Clearify Visualizat... Product sterility is compromised due to breach of the sterile barrier Class II
Jul 8, 2016 Valleylab Laparoscopic Flat L-Hook Electrode 36CM Item Code: E277436 The V... Potential for compromise of the package resulting in a breach of the sterile ... Class II
Jul 8, 2016 Valleylab Laparoscopic Cylindrical Tip Electrode 28CM Item Code: E278628 T... Potential for compromise of the package resulting in a breach of the sterile ... Class II
Jul 8, 2016 Valleylab Laparoscopic Straight Spatula Electrode 28CM Item Code: E278028 ... Potential for compromise of the package resulting in a breach of the sterile ... Class II
Jul 8, 2016 Valleylab Laparoscopic Argon Modified Flat l Electrode 28CM Item Code: E2581... Potential for compromise of the package resulting in a breach of the sterile ... Class II
Jul 8, 2016 Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes 6" Item Code: ... Potential for compromise of the package resulting in a breach of the sterile ... Class II
Jul 8, 2016 Valleylab Laparoscopic AP Argon Blunt Needle Electrode 28cm Item Code: E2583... Potential for compromise of the package resulting in a breach of the sterile ... Class II
Jul 8, 2016 Valleylab Laparoscopic Straight Spatula Electrode 36C Item Code: E277036 T... Potential for compromise of the package resulting in a breach of the sterile ... Class II
Jul 8, 2016 Valleylab Laparoscopic Argon Sharp Needle Electrode 28CM Item Code: E258228 ... Potential for compromise of the package resulting in a breach of the sterile ... Class II
Jul 8, 2016 Valleylab Laparoscopic Wire L-Hook Electrode 28CM Item Code: E278328 The Va... Potential for compromise of the package resulting in a breach of the sterile ... Class II
Jul 8, 2016 Valleylab Laparoscopic Curved Spatula Electrode Retractable 28CM Item Code:... Potential for compromise of the package resulting in a breach of the sterile ... Class II
Jul 8, 2016 Valleylab Laparoscopic Curved Spatula Electrode 28CM Item Code: E278128 Th... Potential for compromise of the package resulting in a breach of the sterile ... Class II
Jul 8, 2016 Valleylab Laparoscopic Wire J-Hook Electrode Retractable 28CM Item Code: E27... Potential for compromise of the package resulting in a breach of the sterile ... Class II
Jul 8, 2016 Valleylab Laparoscopic Wire J-Hook Electrode 36CM Item Code: E277336 The Va... Potential for compromise of the package resulting in a breach of the sterile ... Class II
Jul 8, 2016 Valleylab Laparoscopic Curved Spatula Electrode 36CM Item Code: E277136 The... Potential for compromise of the package resulting in a breach of the sterile ... Class II
Jul 8, 2016 Valleylab Laparoscopic Curved Spatula Electrode 45CM Item Code: E277145 The... Potential for compromise of the package resulting in a breach of the sterile ... Class II
Jul 8, 2016 Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes Item Code: E25... Potential for compromise of the package resulting in a breach of the sterile ... Class II
Jul 8, 2016 Valleylab Laparoscopic Wire L-Hook Electrode Retractable Item Code: E2783R28... Potential for compromise of the package resulting in a breach of the sterile ... Class II
Jul 8, 2016 Valleylab Laparoscopic Wire L-Hook Electrode Retractable Item Code: E2783R3... Potential for compromise of the package resulting in a breach of the sterile ... Class II
Jul 8, 2016 Valleylab Laparoscopic Flat L-Hook Electrode Retractable Item Code: E2784R... Potential for compromise of the package resulting in a breach of the sterile ... Class II
Jul 8, 2016 Valleylab Laparoscopic Wire J-Hook Electrode 28CM Item Code: E278228 The V... Potential for compromise of the package resulting in a breach of the sterile ... Class II
Jul 8, 2016 Valleylab Laparoscopic Flat L-Hook Electrode 28cm Item Code: E278428 The V... Potential for compromise of the package resulting in a breach of the sterile ... Class II
Jul 8, 2016 Valleylab Laparoscopic Wire J-Hook Electrode 45CM Item Code: E277345 The V... Potential for compromise of the package resulting in a breach of the sterile ... Class II
Jul 8, 2016 Valleylab Laparoscopic Flexible Laparoscopic Argon Blade Electrodes 28CM Ite... Potential for compromise of the package resulting in a breach of the sterile ... Class II
Jul 8, 2016 Valleylab Laparoscopic Wire J-Hook Electrode 36CM Item Code: E277236 The V... Potential for compromise of the package resulting in a breach of the sterile ... Class II
Jul 8, 2016 Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes 3" Item Code: ... Potential for compromise of the package resulting in a breach of the sterile ... Class II
Apr 13, 2016 Battery Pack Used with the Capnostream"20 and Capnostream"20p Patient Monitor... Medtronic Respiratory & Monitoring Solutions Announces a Voluntary Recall of ... Class I
Apr 1, 2016 Covidien Kangaroo Connect Enteral Feeding Pump Item Number: 384400 (US) I... Kangaroo Connect Feeding Pump Occlusion alarms fail to alarm Class II
Apr 1, 2016 Covidien Kangaroo Connect Enteral Feeding Pump Item Number: 584400 (OUS) ... Kangaroo Connect Feeding Pump Occlusion alarms fail to alarm Class II
Dec 2, 2015 Covidien Endo GIA Ultra Universal Standard Stapler Handle Ref: EGIAUSTND ... Staplers fail to fire or partially fire and reports of the instrument articul... Class II
Dec 2, 2015 Covidien Endo GIA Ultra Universal 12 mm XL Stapler Handle Ref: EGIAUXL Pr... Staplers fail to fire or partially fire and reports of the instrument articul... Class II
Dec 2, 2015 Covidien Endo GIA Ultra Universal 12 mm Short Stapler Handle Ref: EGIAUSHOR... Staplers fail to fire or partially fire and reports of the instrument articul... Class II
Dec 2, 2015 Best Practice Kits containing certain production lots of Endo GIA Ultra Unive... Staplers fail to fire or partially fire and reports of the instrument articul... 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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