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.
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: 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.
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