Z-1663-2023Class II

Teleflex HORIZON Microclip Titanium Ligating Clips w/tape, REF 005200; for use in general surgical procedures...

Name: Z-1663-2023 Teleflex HORIZON Microclip Titanium Ligating Clips w/tape, REF 005200; for use in general surgical procedures...
Creator: Teleflex Llc
Published: 2023-04-28
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2023-04-28 / Open, Classified

FDA source

TELEFLEX LLC began a recall of Teleflex HORIZON Microclip Titanium Ligating Clips w/tape, REF 005200; for use in general surgical procedures that require vessel or tissue ligation on 2023-04-28. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1663-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-04-28
Posted: 2023-05-30
Recalling firm: Teleflex Medical
Product: Teleflex HORIZON Microclip Titanium Ligating Clips w/tape, REF 005200; for use in general surgical procedures that require vessel or tissue ligation
Product code: FZP Clip, Implantable
Reason for recall: 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: Under Investigation by firm
Action: 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.
Quantity in commerce: 146,606 units
Distribution: worldwide
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1663-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1663-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-07	2023-05-30

Product code FZP

K132658Class IIHemoclip Traditional Ligating Clips, Hemoclip Plus Ligating Clips, Horizon Ligting ClipsTeleflex Medical / cleared 2013-11-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)