WECK recallZ-1663-2023 · Teleflex LLC · initiated Apr 28, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Teleflex LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Teleflex LLC is initiating this voluntary field corrective action because the clip cartridges for the affected product is missing a key feature that restricts the application of the clip to the applier. With this step feature missing on the cartridge, the clip is mounted in a more variable position, allowing the clips to load farther back in the clip applier jaw grooves. This may potentially result in inappropriate or inadequate clip application to vascular structures.
FDA root cause category: Under Investigation by firm
What the company is doing
Teleflex issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 04/28/2023 by FedEx 2nd day mail. The letter explained the issue, potential risk, and requested the following actions: Medical facilities: Cease use and distribution, and isolate the affected product. Circulate the notice to all affected departments. Distributors: Cease use and distribution, and isolate the affected product. Provide the notice to your customers. Teleflex is seeking return of the affected units.
Recall details
- Recall number
- Z-1663-2023
- Status
- Open, Classified
- Initiated by the company
- Apr 28, 2023
- Posted by the FDA
- May 30, 2023
- Recalling firm
- Teleflex LLC
- Quantity
- 146,606 units
- Product code
- FZP
- FDA submissions
- K132658
- Distribution
- worldwide
Product description
Teleflex HORIZON Microclip Titanium Ligating Clips w/tape, REF 005200; for use in general surgical procedures that require vessel or tissue ligation
Code information (models, lots, serial numbers)
UDI/DI 24026704696394, Lot Numbers: 73A2200857, 73A2300018, 73A2300176, 73A2300326, 73A2300520, 73A2300778, 73D2200216, 73D2200559, 73E2200634, 73E2200874, 73E2201099, 73F2200193, 73F2200200, 73F2200482, 73F2200711, 73G2200168, 73G2200345, 73G2200560, 73G2200754, 73H2200115, 73H2200294, 73H2200433, 73H2200453, 73J2200747, 73J2200763, 73K2200014, 73K2200095, 73K2200101, 73K2200299, 73K2200566, 73K2200713, 73L2200064, 73L2200066
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- WECK IPN914931Teleflex Incorporated · CLIP, IMPLANTABLE1 recall0 reports
Product lines
Other devices under the same FDA submission
3 devices cleared under K132658 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- WECK IPN915119Teleflex Incorporated · CLIP, IMPLANTABLE1 report
- WECK IPN915126Teleflex Incorporated · CLIP, IMPLANTABLE1 report
- WECK IPN915128Teleflex Incorporated · CLIP, IMPLANTABLE1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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