CLASS II Device recall · Reported 10 Aug 2022 · FDA Enforcement Report
Container, TS1500 recalled by Turbett Surgical
Turbett Surgical is recalling Turbett Surgical Container, TS1500, distributed nationwide in the US. The recall was initiated on 14 Apr 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1501-2022
- FDA event ID
- 90578
- Recalling firm
- Turbett Surgical, Victor, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Apr 2022
- FDA classified
- 4 Aug 2022
- Reported
- 10 Aug 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 14 Apr 2022 | Recall initiated by company | |
| 4 Aug 2022 | Classified by FDA | +112 days |
| 10 Aug 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Devices were subject to unapproved rework processes.
Product as listed by the FDA
Turbett Surgical Container, TS1500
Where it was distributed
US Nationwide Nationwide: CO, FL, NC and PA.
Questions about this recall
Is Container, TS1500 recalled?
Yes. Turbett Surgical recalled Container, TS1500 on 14 Apr 2022. The recall is Class II and its status is Terminated. Recall number Z-1501-2022.
Why was it recalled?
Devices were subject to unapproved rework processes.
Which lots are affected?
UDI-DI (GTIN): 00859464007113; Lot No./Serial No.: 100036/2017061015, 100036/2017061016, 100036/2017061017, 100036/2017061019, 100036/2017061023, 100036/2017061025, 100065/2017121001 and 100081/2018031004.
Where was it sold?
US Nationwide Nationwide: CO, FL, NC and PA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Turbett Surgical
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Container, TS1200: Indicated recalled by Turbett Surgical | Turbett Surgical | Sterility | Nationwide |
| Device | CLASS II | Container, TS1000: Indicated recalled by Turbett Surgical | Turbett Surgical | Sterility | Nationwide |
| Device | CLASS II | Container, TS1500 recalled by Turbett Surgical | Turbett Surgical | Sterility | CA, NY, PA |
Other Surgical Instruments recalls
All 3,809| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: IV Start KIT recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Sterility | Nationwide |