Reported Jul 13, 2022 · Ongoing
EEA Autosuture Circular Stapler with DST Series Technology, 25mm. Model Numbers EEA25, EEAXL25, EEA2535, and EEAXL2535.
Covidien, LP
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Covidien, LP · 60 Middletown Ave · North Haven, CT · 06473-3908
Is this the product you have?
- EEA Autosuture Circular Stapler with DST Series Technology, 25mm. Model Numbers EEA25, EEAXL25, EEA2535, and EEAXL2535.
- Lot codes and dates
- UDI-DI (GTIN)10884523004731 10884523004748 10884523006056 10884523006124 Lots
511 of 511 codes
P0A1388KYP0A1389KSYP0A1497KYP0A1498KSYP0B1081KYP0B1082KYP0B1083KSYP0B1188KYP0B1189KYP0B1339KYP0B1340KYP0B1460KYP0B1461KYP0B1462KYP0B1494KYP0B1495KYP0B1496KYP0C1183KYP0C1344KYP0C1345KYP0C1346KSYP0C1544KSYP0D0105KYP0D0106KYP0D1244KYP0D1313KYP0D1314KYP0D1315KYP0D1412KYP0D1413KYP0D1415KSYP0E0004KYP0E0005KYP0E1255KSYP0E1273KYP0E1274KYP0E1275KYP0E1276KYP0E1387KSYP0F0198KYP0F0199KYP0F0450KYP0F0451KYP0F0452KYP0F0836SYP0F0837SYP0G0041SYP0G0042SYP0G0063SYP0G0432YP0G0433YP0G0539YP0G0540YP0G0541YP0G0644SYP0G0645SYP0H0014SYP0H0015SYP0H0016SYP0H0230Y
- UDI-DI (GTIN)10884523004731 10884523004748 10884523006056 10884523006124 Lots
- Amount recalled
- 433,560
Where it was sold
- Nationwide
Why it was recalled
The affected staplers have the potential for the staple guide to not be securely attached to the instrument. The issue could cause the component to disengage and if disengaged, could allow the device to transect tissue without forming staples.
This product could cause temporary or reversible health problems — stop using it.
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