Teleflex Recalls WECK AutoEndo5 Clip Appliers Due to Jamming Risk
Teleflex Medical is recalling WECK AutoEndo5 clip appliers because a component discrepancy may cause jamming or misloading, leading to clip failure during surgery.
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 risk of harm (clip failure/jamming) during surgery without reported injuries or illnesses in the source text, meeting the criteria for a High severity score.
Plain-English summary
Teleflex Medical is recalling 34,491 units of the WECK AutoEndo5 Automatic Hem-O-Lok Clip Applier (REF AE05ML). These devices are used to deliver Hem-o-lok ML non-absorbable polymer ligating clips during endoscopic surgical procedures. The recall covers devices distributed worldwide, including the United States and Puerto Rico.
The recall was initiated because certain clip appliers have an increased rate of complaints regarding misloading and jamming. These issues may be caused by a discrepancy in the specification of a component. Misloading or jamming can result in clips falling out of the applier, clip breakage, or the jaws becoming locked in a partially closed position.
Healthcare facilities and distributors should stop using the affected devices and contact Teleflex Medical for further instructions. The specific lot codes affected are listed in the official FDA recall record Z-0496-2020.
The recalled product
- Product
- WECK AutoEndo5, Automatic Hem-O-Lok Clip Applier, REF AE05ML Automatic Endoscopic Surgical Ligating Clip Appliers are delivery devices for Hem-o-lok ML non-absorbable polymer ligating clips
- Manufacturer
- Teleflex Medical
- Affected units
- 34,491
Distribution
Part of a larger recall action
This product is one of 2 recalled by Teleflex Medical under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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