CLASS I Device recall · Reported 22 May 2019 · FDA Enforcement Report
Endoscopic Curved Intraluminal Stapler diameter recalled
Ethicon Endo-Surgery is recalling Endoscopic Curved Intraluminal Stapler diameter, distributed nationwide in the US. The recall was initiated on 11 Apr 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-1273-2019
- FDA event ID
- 82539
- Recalling firm
- Ethicon Endo-Surgery, Blue Ash, OH
- Classification
- Class I
- Status
- Completed
- Recall initiated
- 11 Apr 2019
- FDA classified
- 15 May 2019
- Reported
- 22 May 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Surgical Instruments
Timeline
| 11 Apr 2019 | Recall initiated by company | |
| 15 May 2019 | Classified by FDA | +34 days |
| 22 May 2019 | Published in enforcement report | +7 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 have an insufficient firing stroke to break the washer and completely form staples.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Endoscopic Curved Intraluminal Stapler, 29 mm diameter, Model ECS29A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the anvil shaft in a location remote from the main body of the instrument to improve access and visibility.
Where it was distributed
Worldwide Distribution: US (nationwide) and countries of: Argentina, Aruba, Bahrain, Bangladesh, Belgium, Bolivia, Brazil, Canada, Chile, China, Columbia, Costa Rica, Ecuador, Egypt, El Salvador, Guatemala, Honduras, India, Indonesia, Israel, Jamaica, Japan, Jordan, Korea, Kuwait, Lebanon, Malaysia, Maldives, Mexico, Nepal. Nicaragua, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Qatar, Saudi Arabia, Singapore, Sri Lanka, Taiwan, Thailand, UAE, Uruguay, Vietnam, and Yemen.
Questions about this recall
Is Endoscopic Curved Intraluminal Stapler diameter recalled?
Yes. Ethicon Endo-Surgery recalled Endoscopic Curved Intraluminal Stapler diameter on 11 Apr 2019. The recall is Class I and its status is Completed. Recall number Z-1273-2019.
Why was it recalled?
The staplers may have an insufficient firing stroke to break the washer and completely form staples.
Which lots are affected?
All Lots within EXPIRATION Date Range: February 2023 March 2024
Where was it sold?
Worldwide Distribution: US (nationwide) and countries of: Argentina, Aruba, Bahrain, Bangladesh, Belgium, Bolivia, Brazil, Canada, Chile, China, Columbia, Costa Rica, Ecuador, Egypt, El Salvador, Guatemala, Honduras, India, Indonesia, Israel, Jamaica, Japan, Jordan, Korea, Kuwait, Lebanon, Malaysia, Maldives, Mexico, Nepal. Nicaragua, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Qatar, Saudi Arabia, Singapore, Sri Lanka, Taiwan, Thailand, UAE, Uruguay, Vietnam, and Yemen.
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 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.
More recalls from Ethicon Endo-Surgery
All 58| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Echelon Linear Cutters Reload Blue, intended recalled | Ethicon Endo-Surgery | Sterility | Nationwide |
| Device | CLASS I | Endopath Echelon Vascular White Reload recalled by Ethicon Endo-Surgery | Ethicon Endo-Surgery | Other | Nationwide |
| 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 |
Other Surgical Instruments recalls
All 3,809| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: IV Start KIT recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Sterility | Nationwide |