CLASS I Device recall · Reported 6 Nov 2019 · FDA Enforcement Report
Echelon Flex Endopath Stapler - shaft, Product recalled
Ethicon Endo-Surgery is recalling Echelon Flex Endopath Stapler - shaft, distributed nationwide in the US. The recall was initiated on 3 Oct 2019 and the FDA has classified it as Class I.
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-0200-2020
- FDA event ID
- 83897
- Recalling firm
- Ethicon Endo-Surgery, Blue Ash, OH
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 3 Oct 2019
- FDA classified
- 29 Oct 2019
- Reported
- 6 Nov 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Surgical Instruments
Timeline
| 3 Oct 2019 | Recall initiated by company | |
| 29 Oct 2019 | Classified by FDA | +26 days |
| 6 Nov 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
The staplers may contain an out of specification anvil component within the jaw of the device. This condition may lead to malformed staples, which can compromise staple line integrity. If the staple line is compromised, there is a potential risk of prolonged surgery, postoperative anastomotic leak, hemorrhage, hemorrhagic shock, additional surgical intervention, or death.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
ECHELON FLEX ENDOPATH 60mm Stapler - 340mm shaft, Product Code EC60A
Where it was distributed
Worldwide distribution. US Nationwide. Belgium, Brazil, Canada, Chile, Colombia, Japan, Kuwait, Saudi Arabia, and Singapore.
Questions about this recall
Why was it recalled?
The staplers may contain an out of specification anvil component within the jaw of the device. This condition may lead to malformed staples, which can compromise staple line integrity. If the staple line is compromised, there is a potential risk of prolonged surgery, postoperative anastomotic leak, hemorrhage, hemorrhagic shock, additional surgical intervention, or death.
Which lots are affected?
Lot: T9408M, T94899, T94A9Z
Where was it sold?
Worldwide distribution. US Nationwide. Belgium, Brazil, Canada, Chile, Colombia, Japan, Kuwait, Saudi Arabia, and Singapore.
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 83897| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Echelon Flex Powered Plus Endopath Stapler - shaft, Product recalled | Ethicon Endo-Surgery | Potency & Assay | Nationwide | |
| CLASS I | Echelon Flex Powered Plus Endopath Stapler - shaft, Product recalled | Ethicon Endo-Surgery | Potency & Assay | Nationwide | |
| CLASS I | Echelon Flex Powered Plus Endopath Stapler - shaft, Product recalled | Ethicon Endo-Surgery | Potency & Assay | Nationwide |
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|---|---|---|---|---|---|
| Device | CLASS II | Echelon Linear Cutters Reload Blue, intended recalled | Ethicon Endo-Surgery | Other | OH |
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| Device | CLASS II | Pdsii¿vio¿¿usp6-0(m0.7)¿d/a¿c recalled by Ethicon Endo Surgery | Ethicon Endo Surgery | Other | Nationwide |
| Device | CLASS II | Ethibond Excel Grn Usp2-0(m3) D/a Mh recalled by Ethicon Endo Surgery | Ethicon Endo Surgery | Other | Nationwide |
| Device | CLASS II | Prolene Blu Usp6-0(m0.7) S/a P-1 Prm recalled by Ethicon Endo Surgery | Ethicon Endo Surgery | Other | Nationwide |
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| Device | CLASS II | Adaptable Beach Chair Beach Chair surgical patient positioner recalled | Quantum OPS | Device Malfunction | Nationwide |
| Device | CLASS II | Laparoscopic Prostatectomy kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Halyard Laparoscopy Comprehensive Pack II recalled | GRI Medical & Electronic Technology | Other | Nationwide |
| Device | CLASS II | Gyn Laparoscopy/Laparotomy kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Gyn Laparoscopy Pack kits recalled by Avid Medical | Avid Medical | Other | Nationwide |