RecallRadar

FDA Device recall Z-1629-2013

- Re-New II Endocut Scissor Tip, 16.51mm 5.0mm Ref. 3142 Lot 122295, 122308, 122455, 122875 Manual surgical instrument for general use

On 2013-07-10 the FDA classified a Class II recall of - Re-New II Endocut Scissor Tip, 16.51mm 5.0mm Ref. 3142 Lot 122295, 122308, 122455, 122875 Manual surgical instrument for general use by Surgical Instrument Service And Savings, citing the seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1629-2013
ClassificationClass II
Statusterminated
Initiated2013-05-03
Published2013-07-10
Last updated2026-09-13 11:53 UTC
CompanySurgical Instrument Service And Savings
DistributionUS

Product

- Re-New II Endocut Scissor Tip, 16.51mm 5.0mm Ref. 3142 Lot 122295, 122308, 122455, 122875 Manual surgical instrument for general use.

Reason

The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.

Identifiers

code_info122295, 122308, 122455, 122875.

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-1629-2013%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.