RecallRadar

FDA Device recall Z-1236-2015

Zip 16 Surgical Skin Closure Device

On 2015-03-11 the FDA classified a Class II recall of Zip 16 Surgical Skin Closure Device by Zipline Medical, citing the manufacturers seal may not be present on the Nylon pouch resulting in lack of assurance for sterility.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1236-2015
ClassificationClass II
Statusterminated
Initiated2015-02-05
Published2015-03-11
Last updated2026-09-13 11:53 UTC
CompanyZipline Medical
DistributionUS

Product

Zip 16 Surgical Skin Closure Device; 16 cm Product number PS1160; Rx only, Sterile Indicated for use during and after skin incision procedures to approximate skin and hold together skin edges until healing can take place.

Reason

The manufacturers seal may not be present on the Nylon pouch resulting in lack of assurance for sterility.

Identifiers

code_infoLot 1002539, Exp 2015-06; 1002719, Exp.2015-08; 1002887, Exp 2015-10; 1003054, Exp 2015-12

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1236-2015%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.