Browse Device Recalls
17 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 17 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 17 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 19, 2024 | AD-TECH Spencer Probe Depth Electrode, REF SD06R-AP58X-000 6-Contact 1.12mm (... | Ad-Tech is recalling these A-Style SD Depth Electrodes because a label discrepancy was identified... | Class II | Ad-Tech Medical Instrument Corporation |
| Sep 19, 2024 | AD-TECH Spencer Probe Depth Electrode, REF SD04R-AP58X-000 4-Contact 1.12mm (... | Ad-Tech is recalling these A-Style SD Depth Electrodes because a label discrepancy was identified... | Class II | Ad-Tech Medical Instrument Corporation |
| Sep 19, 2024 | AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (... | Ad-Tech is recalling these A-Style SD Depth Electrodes because a label discrepancy was identified... | Class II | Ad-Tech Medical Instrument Corporation |
| Aug 9, 2021 | Ad-Tech TECH ATTACH Cable- Product Usage: Designed for the purpose of connect... | Incorrect version of labels were used. | Class II | Ad-Tech Medical Instrument Corporation |
| Aug 9, 2021 | Ad-Tech Lightweight CABRIO Cable - Product Usage: Designed for the purpose of... | Incorrect version of labels were used. | Class II | Ad-Tech Medical Instrument Corporation |
| Aug 9, 2021 | Ad-Tech Lightweight TECH ATTACH Cable - Product Usage: Designed for the purpo... | Incorrect version of labels were used. | Class II | Ad-Tech Medical Instrument Corporation |
| Aug 27, 2019 | AD-TECH Drill Sleeve Guides, used with Ad-Tech Placement Kits: (a) REF DSG-9... | The inner diameter of the drill sleeve guide raw material was found to be under tolerance, potent... | Class II | Ad-Tech Medical Instrument Corporation |
| Jun 18, 2019 | Skull Anchor Bolts | Supplemental information provided with devices may indicate that the subdural electrodes, depth e... | Class II | Ad-Tech Medical Instrument Corporation |
| Jun 18, 2019 | Depth Electrodes, Foramen Ovale Depth Electrodes, Macro Micro Depth Electrode... | Supplemental information provided with devices indicates that the subdural electrodes, depth elec... | Class II | Ad-Tech Medical Instrument Corporation |
| Jun 18, 2019 | LSB Style Anchor Bolt. Labeled with the following parts: 13mm anodized ... | On June 12, 2019 Ad-Tech was made aware that on three different occasions between March 1, 2019 a... | Class II | Ad-Tech Medical Instrument Corporation |
| Jun 18, 2019 | Dual-Sided Interhemispheric, Grid, Intraoperative, Strip, Wyler Subdural Elec... | Supplemental information provided with devices indicates that the subdural electrodes, depth elec... | Class II | Ad-Tech Medical Instrument Corporation |
| Apr 16, 2019 | AD-TECH Spencer Probe Depth Electrode Product Usage: The Ad-Tech Depth El... | An Ad-Tech Clinical Specialist, attended a case on April 15, 2019. During the case the surgeon en... | Class II | Ad-Tech Medical Instrument Corporation |
| May 2, 2018 | AD-TECH Medical Instrument Corporation Drill Sleeve Guides DSG-6-3-090-2.4N u... | The diameter of the drill sleeve guide raw material was found to be under tolerance, potentially ... | Class II | Ad-Tech Medical Instrument Corporation |
| Dec 20, 2017 | Disposable Drill Kit which includes two drill bits, two drill stops, and two ... | There is a possibility that DDK2-2.4-30X Disposable Drill Kits, Lot Number 111664 208140649 conta... | Class II | Ad-Tech Medical Instrument Corporation |
| Mar 29, 2016 | Ad-Tech Electrode Connection System/Cables. Lightweight TECH-ATTACH Cable Mo... | Ad-Tech is recalling unopened/unused sterile cables intended to be used only with all compatible ... | Class II | Ad-Tech Medical Instrument Corporation |
| Oct 8, 2014 | Box Label: 3 mm Cueva Electrode Kit, Sterile EO, Rx Only, REF. CNE1-3KDINX . ... | The recall has been initiated due to concerns that the applicator wand may malfunction potentiall... | Class II | Ad-Tech Medical Instrument Corporation |
| Dec 18, 2012 | Ad-Tech Medical Instrument Corporation Macro Micro Subdural Electrode. For t... | The microelectrodes are not flush with the silastic substrate, may contain sharp edges capable of... | Class I | Ad-Tech Medical Instrument Corporation |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.