CLASS II Device recall · Reported 23 May 2018 · FDA Enforcement Report
Endo GIA" Auto Suture" Universal Articulating Loading Unit recalled
Covidien Medtronic is recalling Endo GIA" Auto Suture" Universal Articulating Loading Unit- (, distributed nationwide in the US. The recall was initiated on 26 Apr 2018 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-1814-2018
- FDA event ID
- 79974
- Recalling firm
- Covidien Medtronic, NORTH HAVEN, CT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Apr 2018
- FDA classified
- 6 Jul 2018
- Reported
- 23 May 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Surgical Instruments
Timeline
| 26 Apr 2018 | Recall initiated by company | |
| 23 May 2018 | Published in enforcement report | +27 days |
| 6 Jul 2018 | Classified by FDA | +44 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Endo GIA" Auto Suture" Universal Articulating Loading Unit 30mm- 2.0mm ( Item Code 030450) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is determined by the selection of the 2.0 mm, 2.5 mm, 3.5 mm or 4.8 mm single use loading unit. The Endo GIA universal staplers will accommodate any of the single use loading unit sizes that are available in the 30 mm, 45 mm and 60 mm lines.
Where it was distributed
Worldwide and US Nationwide
Questions about this recall
Is Endo GIA" Auto Suture" Universal Articulating Loading Unit- ( recalled?
Yes. Covidien Medtronic recalled Endo GIA" Auto Suture" Universal Articulating Loading Unit- ( on 26 Apr 2018. The recall is Class II and its status is Terminated. Recall number Z-1814-2018.
Why was it recalled?
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
Which lots are affected?
Lots: N7L0306KX, N7M0221KX, N8B0724KX, N8C0958KX, N8C1303KRX GTIN # 1 (Inner Carton) -GTIN #1 10884523002812 GTIN # 2 (Outer Carton)- GTIN # 2 20884523002819
Where was it sold?
Worldwide and US Nationwide
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.
More recalls from Covidien Medtronic
All 55| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Tri-Staple 0 Black Intelligent Reload for use recalled | Covidien Medtronic | Packaging Defects | Nationwide |
| Device | CLASS II | Endo GIA Curved Tip Articulating Vascular/Medium Reload recalled | Covidien Medtronic | Packaging Defects | Nationwide |
| Device | CLASS II | Tri-Staple 0 Intelligent Reload for use recalled by Covidien Medtronic | Covidien Medtronic | Packaging Defects | Nationwide |
| Device | CLASS II | Tri-Staple 0 Curved Tip Intelligent Reload for use recalled | Covidien Medtronic | Packaging Defects | Nationwide |
| Device | CLASS II | Endo GIA Extra Thick Black Articulating Reload recalled | Covidien Medtronic | Packaging Defects | Nationwide |
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