Ad-Tech Electrode Connection System/Cables — Class II medical device recall Z-1503-2016
Terminated recall by Ad-Tech Medical Instrument Corporation, reported 2016-04-27, distributed in GA, MI. Ad-Tech is recalling unopened/unused sterile cables intended to be used only with all compatible Ad-Tech elect
| Recall number | Z-1503-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ad-Tech Medical Instrument Corporation, Racine, WI, United States |
| Recall initiated | 2016-03-29 |
| Classified | 2016-04-15 |
| Reported by FDA | 2016-04-27 |
| Terminated | 2016-08-24 |
| Distributed | GA, MI |
| Countries outside the US | BR, CO, FR, GB |
| Quantity | 197 |
| Reason classes | sterility, packaging |
| Lot numbers | 208140507, 208140552, 208140556, 208140559, 208140560, 208140561, 208140562, 208140563, 208140564R, 208140579, 208140581, 208140586, 208140588R, 208140590, 208140604 |
| Model numbers | FO-LDC-4DINX, L-DCL-4DINX, L-SRL-64BDINX |
Product
Ad-Tech Electrode Connection System/Cables. Lightweight TECH-ATTACH Cable Models: 1. L-DCL-4DINX (4 contacts: 1 terminal block with 4 connectors each); 2. L-DCL-6DINX (6 contacts: 1 terminal block with 6 connectors each); 3. L-DCL-8DINX (8 contacts: 1 terminal block with 8 connectors each); 4. L-DCL-16BDINX (16 contacts: 1 terminal block with 16 connectors each); 5. L-DCL-32BDINX (32 contacts: 2 terminal blocks with 16 connectors each); 6. L-DCL-64BDINX (64 contacts: 4 terminal blocks with 16 connectors each). FO TECH-ATTACH Connection Cable model FO-LDC-4DINX (4 contacts: 1 terminal block with 4 connectors each). Tech-Attach: these cables require the use of an additional component - the connector block. The tail of the electrode is inserted into the block and the block in turn mates with the cable. A key-pin is used to ensure proper orientation. The cable terminated in EEG compatible connector sockets. Lightweight CABRIO Cable, model L-SRL-64BDINX (64 contacts: 4 terminal blocks with 16 connectors each). Cabrio cables are similar to Tech-Attach cables except that the block portion is pre-attached. The tail of an electrode is inserted into this portion which then hinges shut.
Reason for recall
Ad-Tech is recalling unopened/unused sterile cables intended to be used only with all compatible Ad-Tech electrodes for the purpose of connecting these electrodes to third party monitors/stimulators. This recall has been initiated due to package failures (i.e. compromised sterile barriers) that were identified during the execution of a shipping simulation investigation.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1503-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.