Ad-Tech Medical Instrument Corporation
Complete recall history across all FDA and CPSC categories — 17 total recalls
Ad-Tech Medical Instrument Corporation 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 (17)
FDA medical device enforcement actions by Ad-Tech Medical Instrument Corporation
| Date | Product | Reason | Class |
|---|---|---|---|
| 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 discre... | Class II |
| 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 discre... | Class II |
| 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 discre... | Class II |
| Aug 9, 2021 | Ad-Tech TECH ATTACH Cable- Product Usage: Designed for the purpose of connect... | Incorrect version of labels were used. | Class II |
| Aug 9, 2021 | Ad-Tech Lightweight CABRIO Cable - Product Usage: Designed for the purpose of... | Incorrect version of labels were used. | Class II |
| Aug 9, 2021 | Ad-Tech Lightweight TECH ATTACH Cable - Product Usage: Designed for the purpo... | Incorrect version of labels were used. | Class II |
| 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 und... | Class II |
| Jun 18, 2019 | Skull Anchor Bolts | Supplemental information provided with devices may indicate that the subdural... | Class II |
| Jun 18, 2019 | Depth Electrodes, Foramen Ovale Depth Electrodes, Macro Micro Depth Electrode... | Supplemental information provided with devices indicates that the subdural el... | Class II |
| 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 bet... | Class II |
| Jun 18, 2019 | Dual-Sided Interhemispheric, Grid, Intraoperative, Strip, Wyler Subdural Elec... | Supplemental information provided with devices indicates that the subdural el... | Class II |
| 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... | Class II |
| 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 tol... | Class II |
| 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 11... | Class II |
| 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 ... | Class II |
| 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 ma... | Class II |
| 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 sh... | Class I |
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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