Z-2622-2017Class II

Covidien Endo Peanut 5mm Auto Suture Blunt Dissector Item Code: 173019 The instrument has indications in...

Name: Z-2622-2017 Covidien Endo Peanut 5mm Auto Suture Blunt Dissector Item Code: 173019 The instrument has indications in...
Creator: Covidien LLC
Published: 2017-05-09
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2017-05-09 / Terminated / root cause: manufacturing process

FDA source

Covidien LLC began a recall of Covidien Endo Peanut 5mm Auto Suture Blunt Dissector Item Code: 173019 The instrument has indications in endoscopic surgery for swabbing small amounts of fluid... on 2017-05-09. FDA classified it as Class II and gives the reason as "Cotton tip of the device may disengage due to insufficient adhesive". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2622-2017
Classification: Class II
Status: Terminated
Initiated: 2017-05-09
Posted: 2017-06-23
Terminated: 2019-02-13
Recalling firm: Medtronic, Inc.
Product: Covidien Endo Peanut 5mm Auto Suture Blunt Dissector Item Code: 173019 The instrument has indications in endoscopic surgery for swabbing small amounts of fluid or for blunt dissection of soft tissue(s) and structures, or as an aid in controlling minor intraoperative bleeding
Product code: GCJ Laparoscope, General & Plastic Surgery
Reason for recall: Cotton tip of the device may disengage due to insufficient adhesive
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Medtronic consignees were notified via Federal Express or certified mail on May 9, 2017, and the letter informs customers of the potential for the tip of the device to disengage from the device and the actions they should take. Accounts requested to discontinue use, quarantine and return product. Customers are requested to complete and acknowledge receipt of the Urgent Field Corrective Action Notice. Questions regarding this communication, please contact your Medtronic representative or Customer Service at 800-962-9888, option 2. For questions regarding this recall call 203-492-5000.
Quantity in commerce: 194,851
Distribution: Nationwide Distribution
Product codes and lots: Lot Numbers: M5K04X to M7A01X Exp Date: 2020-October through 2022-January

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2622-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2622-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-05	2017-06-23

Product code GCJ

K931962Class IINon-Absorbable GauzeUnited States Surgical, A Division of Tyco Healthc / cleared 1993-12-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)