ModerateClass IIOngoing

FDA Devices recall · Reported November 27, 2019

WECK Hem-O-Lok AutoEndo5, 5mm Automatic Endoscopie Hem-o-lok Applier, REF 543965 Automatic Endoscopic Surgical Ligating Clip Appliers are delivery devices for Hem-o-lok ML non-absorbable polymer ligating clips

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on November 27, 2019. Severity: Moderate. Recall number: Z-0497-2020.

Q: Where was the recalled product distributed?

Distribution: Worldwide distribution, including US nationwide (including Puerto Rico)..

Q: Should I stop using a recalled medication or medical device?

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Certain clip appliers have an increase in misloading and/or jamming related complaints that may be due to a discrepancy in the specification a component. Misloading and/or jamming…

Recall #: Z-0497-2020
Affected scope: 4099 devices
Initiated: October 4, 2019

Compiled from official public sources by the publisher. · Updated September 2026

Verify with FDA Devices →

View my saved recalls

Teleflex Medical recalled WECK Hem-O-Lok AutoEndo5, 5mm Automatic Endoscopie Hem-o-lok Applier, REF 543965 Au… - a moderate-severity action.

WECK Hem-O-Lok AutoEndo5, 5mm Automatic Endoscopie Hem-o-lok Applier, REF 543965 Au… was recalled by Teleflex Medical in November 27, 2019. Reason: Certain clip appliers have an increase in misloading and/or jamming related complaints that may be due to a d…. Check the official notice for the remedy. Verify recall #Z-0497-2020 with the FDA Devices before acting.

The recall

Teleflex Medical issued this moderate-severity FDA Devices recall-Certain clip appliers have an increase in misloading and/or jamming related complaints that may be due to a d….

Moderate
severity level: 4K units
affected scope: Class II
classification: November 27, 2019
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-0497-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

WECK Hem-O-Lok AutoEndo5, 5mm Automatic Endoscopie Hem-o-lok Applier, REF 543965 Automatic Endoscopic Surgical Ligating Clip Appliers are delivery devices for Hem-o-lok ML non-absorbable polymer ligating clips

Reason for recall

Certain clip appliers have an increase in misloading and/or jamming related complaints that may be due to a discrepancy in the specification a component. Misloading and/or jamming may lead to clips falling out of the applier, clip breakage, or the jaws becoming locked in a partially closed position (jammed).

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Ongoing
Recall number	Z-0497-2020
Date reported	November 27, 2019
Date initiated	October 4, 2019
Recalling firm	Teleflex Medical
Firm location	Morrisville, NC
Affected scope	4099 devices
Distribution	Worldwide distribution, including US nationwide (including Puerto Rico).

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

4099 devices units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) -

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-0497-2020) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on November 27, 2019. Severity: Moderate. Recall number: Z-0497-2020.

Where was the recalled product distributed? ▼

Distribution: Worldwide distribution, including US nationwide (including Puerto Rico)..

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar severity · nearest report date

Same archive severity grade (Moderate), closest by report date among other firms and states.

Stanley Black & Decker Recalls Wooden Han… 2019-11-27 Perrigo Neomycin and Polymixin B Sulfates… 2019-11-27 Perrigo Neo-Polycin neomycin and polymixi… 2019-11-27 Perrigo Sterile Neo-Polycin HC (neomycin … 2019-11-27

Similar Medical Devices · nearest report date

Same product category, closest by report date among other firms and states (deduped against the severity set).

Monarch, Aspirating Biopsy Needle, REF: M… 2019-11-27 SOMATOM go.Top, Models 11061640 & 1106164… 2019-11-27 EPISTAXIS TRAY Kit Code: MNS10165 2019-11-27 YNHH SCOPE KIT Kit Code: MNS10475 2019-11-27

Compare this recall with GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VS… → · All Medical Devices recalls

This recall: FDA Devices, reported November 27, 2019. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026