Teleflex Auto Endo5 Clip Applier Recalled for Clip Misalignment
Teleflex Medical is recalling 13,710 units of the Auto Endo5 Automatic Hem-o-lok Clip Applier because clips may misalign, jam, or fall out of the device.
What this means for you
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: The recall is classified as FDA Class II, and the hazard involves a mechanical failure in a surgical device that could lead to patient harm, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Teleflex Medical is recalling 13,710 units of the WECK from TELEFLEX Auto Endo5 Automatic Hem-o-lok Clip Applier (REF AE05ML, IPN010797). The recall is due to a non-conformity that may cause clips to misalign, jam, or fall out of the applier.
The affected products were distributed nationwide in the United States and in Australia, Canada, Singapore, Thailand, China, Taiwan, Belgium, Japan, and South Korea. The recall covers specific lot numbers listed in the agency's official record.
Healthcare providers and facilities should stop using the affected devices and contact Teleflex Medical for instructions on how to return or replace the products.
The recalled product
- Product
- WECK(R) from TELEFLEX Auto Endo5(R), Automatic Hem-o-lok(R) Clip Applier, REF AE05ML (IPN010797) Rx ONLY, STERILE EO
- Manufacturer
- Teleflex Medical
- Affected units
- 13,710
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lot numbers: 73A1700701
- 73H1600582
- 73B1700183
- 73H1600583
- 73B1700567
- 73H1600663
- 73C1600069
- 73H1600664
- 73C1600070
- 73H1600665
- 73C1600071
- 73H1600666
- 73C1700288
- 73H1600667
- 73C1700289
- 73H1600668
- 73C1700290
- 73J1600135
- 73C1700292
- 73J1600136
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Teleflex Medical
See all →- LowTeleflex RuSCH Male External Catheter Recalled for Incorrect Sterility Labeling
FDA (Devices) · 2020-01-22
- LowTeleflex RuSCH Male External Catheter Recalled for Incorrect Sterility Labeling
FDA (Devices) · 2020-01-22
- ModerateTeleflex Sheridan Endobronchial Tubes Recalled for Incorrect Labeling
FDA (Devices) · 2019-12-25
- HighTeleflex Recalls Arrow EZ-IO Intraosseous Vascular Access System Needles
FDA (Devices) · 2019-12-25
- HighTeleflex Recalls Arrow EZ-IO Intraosseous Vascular Access System Needles
FDA (Devices) · 2019-12-25
Same hazard · mechanical failure
See all →- HighIMRIS ORT300 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighIMRIS ORT200 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighForest River Transit Buses Recalled for Wheelchair Lift Control Failure
NHTSA · 2026-09-01
- HighBlue Bird Recalls Vision School Buses Due to Wheelchair Lift Defect
NHTSA · 2026-08-31
- SevereMagic Tilt Watercraft Trailers Recalled Due to Winch Weld Failure
NHTSA · 2026-08-28