FDA Device recall Z-1111-2022
Turbett Surgical Container, TS1500
- FDA Device
- Class II
- ongoing
- Published 2022-05-25
On 2022-05-25 the FDA classified a Class II recall of Turbett Surgical Container, TS1500 by Turbett Surgical, citing eight units manufactured before June 2019 have exhibited weld failures breaching the sterile barrier after prolonged use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1111-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-04-01 |
| Published | 2022-05-25 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Turbett Surgical |
| Distribution | CA, NY, PA |
Product
Turbett Surgical Container, TS1500
Reason
Eight units manufactured before June 2019 have exhibited weld failures breaching the sterile barrier after prolonged use.
Identifiers
| code_info | UDI-DI (GTIN): 00859464007113 Lot # S/N 100036 2017051001 100036 2017051004 100036 2017051005 100036 2017061…UDI-DI (GTIN): 00859464007113 Lot # S/N 100036 2017051001 100036 2017051004 100036 2017051005 100036 2017061018 100036 2017061026 100036 2017051000 100036 2017051003 100036 2017061021 100036 2017061022 100036 2017061020 100036 2017061011 100036 2017061012 100001 2016071009 100001 2016081005 ***Updated 7/11/22*** Lot # S/N 100036 2017051006 100036 2017051008 100181 2019081010 160522-1 2016071003 160522-1 2016071007 160522-1 2016071008 160522-1 2016071010 100004 2016091006 100004 2016091007 100065 2017121003 100065 2017121007 100125 2018010001 100125 2018010010 100099 2018011002 100099 2018011009 100099 2018011011 100099 2018031005 100099 2018031006 100099 2018031007 100083 2018031009 100083 2018031010 100083 2018031011 100083 2018031012 100083 2018031013 100099 2018081003 100099 2018081004 100099 2018081005 100099 2018081006 100099 2018081007 100099 2018081008 100099 2018081009 100099 2018081010 100099 2018091001 100099 2018091002 100099 2018091003 100099 201809100 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1111-2022%22
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