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Ad-Tech Electrode Connection System/Cables. Lightweight TECH-ATTACH Cable Models: 1. L-DCL-4...

FDA Device Recall #Z-1503-2016 — Class II — March 29, 2016

Recall Summary

Recall Number Z-1503-2016
Classification Class II — Moderate risk
Date Initiated March 29, 2016
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Ad-Tech Medical Instrument Corporation
Location Racine, WI
Product Type Devices
Quantity 197

Product Description

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.

Distribution Pattern

Distributed in the states of GA and MI, and the countries of FRANCE, UNITED KINGDOM, COLOMBIA, and BRAZIL.

Lot / Code Information

Lot Numbers: 208140507, 208140552, 208140556, 208140559, 208140560, 208140561, 208140562, 208140563, 208140564R, 208140579, 208140581, 208140586, 208140588R, 208140590, 208140604.

Other Recalls from Ad-Tech Medical Instrument Corporation

Recall # Classification Product Date
Z-0219-2025 Class II AD-TECH Spencer Probe Depth Electrode, REF SD04... Sep 19, 2024
Z-0220-2025 Class II AD-TECH Spencer Probe Depth Electrode, REF SD06... Sep 19, 2024
Z-0221-2025 Class II AD-TECH Spencer Probe Depth Electrode, REF SD08... Sep 19, 2024
Z-2495-2021 Class II Ad-Tech Lightweight TECH ATTACH Cable - Product... Aug 9, 2021
Z-2496-2021 Class II Ad-Tech TECH ATTACH Cable- Product Usage: Desig... Aug 9, 2021

Frequently Asked Questions

Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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