Device recall: WECK(R) from TELEFLEX Auto Endo5(R), Automatic Hem-o-lok(R) Clip Applier, REF AE05ML (IPN010797) Rx ONLY, STERILE EO

Class II FDA enforcement event 78242. Recall start date: 5 Oct 2017. Status in the FDA record: Terminated. Termination date: 20 Jan 2023.

Reason for recall, in the words of FDA

The product has a non-conformity that may cause clips to mislead, jam or fall out of the applier.

Class II, in the words of FDA

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

Teleflex Medical started this device recall on 5 Oct 2017. The firm address in the FDA record is in Research Triangle Park, NC. FDA put the recall in Class II. FDA event 78242 has 1 product record. The first FDA enforcement report date is 15 Nov 2017. The record gives the status Terminated, with the termination date 20 Jan 2023.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Nationwide and Australia, Canada, Singapore, Thailand, China, Taiwan, Belgium, Japan, S. Korea

Recalling firm

Teleflex Medical, Research Triangle Park, NC.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 78242: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0083-2018	WECK(R) from TELEFLEX Auto Endo5(R), Automatic Hem-o-lok(R) Clip Applier, REF AE05ML (IPN010797) Rx ONLY, STERILE EO	13,710 units	Class II	Terminated	15 Nov 2017

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2017: 1,091
Share of these events in Class II: 93%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 82

Other events of the firm

Other FDA enforcement events of Teleflex Medical
Initiated	Product (first record)	Type	Class	Records
30 Oct 2019	HUDSON RCI SHERIDAN SHERI-BRONCH Endobronchial Tube REF 5-16135 - Product Usage: The Sheridan Endobronchial Tubes are in	Device	Class II	1
8 Oct 2019	Arrow EZ-IO Intraosseous Vascular Access System 15mm Needle+Stabilizer Kit, Product Code 9018P-VC-005 - Product Usage: T	Device	Class II	3
4 Oct 2019	WECK AutoEndo5, Automatic Hem-O-Lok Clip Applier, REF AE05ML Automatic Endoscopic Surgical Ligating Clip Appliers are de	Device	Class II	2
30 Jul 2019	Hudson RCI Sheridan LTS: a) 4.0 mm, REF 5-11108 b) 5.0 mm, REF 5-11110 c) 6.0 mm, REF 5-11112 Product Usage: Tracheal tu	Device	Class I	8
1 Jul 2019	Rusch EasyCath Kit	Device	Class II	1
24 May 2019	Hudson RCI Sheridan LTS, Product Code 5-11112 Product Usage: Tracheal tube/airway management	Device	Class I	8
10 May 2019	Teleflex HUDSON RDI NEONATAL ConchaSmart Breathing Circuit with Dual Heated Limb and ConchaSmart Column: a) REF 870-07KI	Device	Class I	1
1 Apr 2019	RUSCH LASERTUBE (Rubber), Order No. : 102004-000040, REF 102004, SIZE I.D. mm 4,0	Device	Class II	5
27 Feb 2019	Teleflex MEDICAL RuSCH One piece Male External Regular Catheter W/O Tape, REF A1500	Device	Class III	2
14 Jan 2019	RUSCH CARE Premium Drain bag, 2000mlm REF 390000 urine collection device	Device	Class III	2

Teleflex Medical: all 82 events

Official channels

FDA enforcement report Z-0083-2018The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 78242. https://recallregister.com/fda/ii/78242/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Nationwide and Australia, Canada, Singapore, Thailand, China, Taiwan, Belgium, Japan, S. Korea
What quantity of product is in FDA event 78242?: The FDA record gives this quantity: 13,710 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2017 have the same class?: 93% of the 1,091 device events that started in 2017 are in Class II.