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.
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.
Explore More Recalls
Search recalls by category, state, reason, or firm across all our databases.