Z-1212-2019Class II

Covidien Endo Grasp Auto Suture Grasper 5mm REF: 173030 The Covidien Endo Grasp" Auto Suture" grasper 5 mm...

Name: Z-1212-2019 Covidien Endo Grasp Auto Suture Grasper 5mm REF: 173030 The Covidien Endo Grasp" Auto Suture" grasper 5 mm...
Creator: Covidien Llc
Published: 2019-03-13
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2019-03-13 / Terminated / root cause: manufacturing process

FDA source

COVIDIEN LLC began a recall of Covidien Endo Grasp Auto Suture Grasper 5mm REF: 173030 The Covidien Endo Grasp" Auto Suture" grasper 5 mm instrument has applications in a variety of... on 2019-03-13. FDA classified it as Class II and gives the reason as "Sterilization method used was not consistent with the labeling and the approved sterilization method". 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-1212-2019
Classification: Class II
Status: Terminated
Initiated: 2019-03-13
Posted: 2019-04-23
Terminated: 2020-04-23
Recalling firm: Medtronic, Inc.
Product: Covidien Endo Grasp Auto Suture Grasper 5mm REF: 173030 The Covidien Endo Grasp" Auto Suture" grasper 5 mm instrument has applications in a variety of gynecologic, general, urologic, thoracic and endoscopic procedures for temporary grasping/clamping of tissue and small tubular structures.
Product code: HDA Forceps, Obstetrical
Reason for recall: Sterilization method used was not consistent with the labeling and the approved sterilization method
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Medtronic notified consignees via an "URGENT MEDICAL DEVICE RECALL" letter by Federal Express and/or certified mail on March 13, 2019. The letter informs customers of the recall of twenty-one production lot of Covidien Endo Clinch" and Endo Grasp" Auto Suture" graspers 5mm as the sterilization method used for these lots was not consistent with the labeling and the approved sterilization method. Customers are instructed to take the following actions: 1. Please immediately quarantine and discontinue use of the affected item codes and lots listed above. 2. Please return affected product as indicated below. 3. If you have distributed the Endo Clinch" II or Endo Grasp" Auto Suture" graspers 5mm listed above, please promptly forward the information from this letter to those recipients. 4. Complete the Recalled Product Return Form even if you do not have inventory. -----If you have inventory email to: [email protected] fax to: 800-895-6140. -----Exception: Customers with zero inventory, fax to 203-492-7719 or email to [email protected] If purchased by distributor, fax to 203-492-7719 or email [email protected]. If you have any questions or concerns, please do not hesitate to contact your Medtronic representative or Customer Service at 800-962-9888, option 2.
Quantity in commerce: 240 units
Distribution: Worldwide Distribution: US (Nationwide) and to countries of: Canada, Chile, Costa Rica, Guatemala, Japan, Mexico, Panama, Slovakia, Spain, Switzerland and Turkey.
Product codes and lots: Lot Numbers: P8D1335PRX P8D1336PRX P8D1605PRX

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1212-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1211-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-01	2019-04-23
Z-1212-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-01	2019-04-23
Z-1213-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-01	2019-04-23

Product code HDA

K903205Class IIAuto Suture(r) Endoscopic ClampUnited States Surgical, A Division of Tyco Healthc / cleared 1990-10-11

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)