CLASS II Device recall · Reported 1 May 2019 · FDA Enforcement Report
Endo Grasp Auto Suture Grasper recalled by Covidien
Covidien is recalling Covidien Endo Grasp Auto Suture Grasper, distributed nationwide in the US. The recall was initiated on 13 Mar 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1212-2019
- FDA event ID
- 82426
- Recalling firm
- Covidien, Mansfield, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Mar 2019
- FDA classified
- 23 Apr 2019
- Reported
- 1 May 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 13 Mar 2019 | Recall initiated by company | |
| 23 Apr 2019 | Classified by FDA | +41 days |
| 1 May 2019 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Sterilization method used was not consistent with the labeling and the approved sterilization method
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution: US (Nationwide) and to countries of: Canada, Chile, Costa Rica, Guatemala, Japan, Mexico, Panama, Slovakia, Spain, Switzerland and Turkey.
Questions about this recall
Is Endo Grasp Auto Suture Grasper recalled?
Yes. Covidien recalled Endo Grasp Auto Suture Grasper on 13 Mar 2019. The recall is Class II and its status is Terminated. Recall number Z-1212-2019.
Why was it recalled?
Sterilization method used was not consistent with the labeling and the approved sterilization method
Which lots are affected?
Lot Numbers: P8D1335PRX P8D1336PRX P8D1605PRX
Where was it sold?
Worldwide Distribution: US (Nationwide) and to countries of: Canada, Chile, Costa Rica, Guatemala, Japan, Mexico, Panama, Slovakia, Spain, Switzerland and Turkey.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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