Turbett Surgical Container TS1500 weld failures breach sterile barrier
The Turbett Surgical Container TS1500 is being recalled because eight units manufactured before June 2019 have exhibited weld failures that breach the sterile barrier during prolonged use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a FDA Class II recall for a medical device with a breach of sterile barrier—a significant risk in surgical equipment. However, no illnesses or injuries have been reported, and the hazard remains theoretical. Per the rubric, absence of reported harm with a risk-of-harm product scores at most 3.
Plain-English summary
The Turbett Surgical Container TS1500 is being recalled due to weld failures that breach the sterile barrier. Eight units manufactured before June 2019 have exhibited these weld failures during prolonged use.
The recall involves 232 units distributed to healthcare facilities in Pennsylvania, California, and New York. The affected units are identified by lot numbers and serial numbers detailed in FDA recall notice Z-1111-2022.
A breach in the sterile barrier of a surgical container poses a risk of contamination. Healthcare facilities should verify their inventory against the list of affected units.
The recalled product
- Product
- Turbett Surgical Container, TS1500
- Manufacturer
- TURBETT SURGICAL, LLC
- Affected units
- 232
Distribution
Related recalls
Same hazard · weld failure
See all →- SevereElectric fat tire trikes recalled after frames broke near a weld
CPSC · 2025-12-18
- High20mm vented vial spikes recalled over port weld separation risk
FDA (Devices) · 2025-11-05
- HighAnti-siphon smallbore extension sets recalled over port weld separation risk
FDA (Devices) · 2025-11-05
- HighChemotherapy bag spikes recalled because port weld may separate and leak
FDA (Devices) · 2025-11-05
- HighDouble port syringe transfer sets recalled over port weld separation risk
FDA (Devices) · 2025-11-05
Similar recalls
- HighTurbett Surgical Container TS1200 Recalled Due to Potential Weld Failures
FDA (Devices) · 2023-02-08
- HighTurbett Surgical Container TS1000 may have weld failures breaching sterile barrier
FDA (Devices) · 2023-02-08
- ModerateTurbett Surgical Container TS1500: Unapproved Rework Processes
FDA (Devices) · 2022-08-10
- HighSurgical Suture Kit Recalled for Uncertain Sterile Barrier Integrity
FDA (Devices) · 2022-06-01
- SevereCustomed Breat Pack-TPSC Recalled for Sterility Compromise and Contamination Risk
FDA (Devices) · 2014-12-10
- HighInjection kits recalled over voids in sterile Tyvek pouch seals
FDA (Devices) · 2026-02-11