EEA Autosuture Circular Stapler with DST Series Technology, 25mm. Model Numbers EEA25, EEAXL25, EEA2535, and EEAXL2535.
Check against the official notice below — it lists the full affected range.
Covidien, LP is recalling EEA Autosuture Circular Staplers with DST Series Technology in 25mm models (model numbers EEA25, EEAXL25, EEA2535, and EEAXL2535) due to a defect in which the staple guide may not be securely attached to the instrument. If the staple guide becomes disengaged during use, the device could cut tissue without forming staples, which could result in serious patient harm. Approximately 433,560 affected staplers have been distributed worldwide, including throughout the United States.
The recall affects staplers from multiple lot codes, which can be identified by their UDI-DI numbers and lot numbers listed in the recall notice. The source document does not specify what remedy is available to consumers or healthcare facilities who have these staplers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: Worldwide distribution - US Nationwide. Quantity: 433,560 Lot/code info: UDI-DI (GTIN): 10884523004731 10884523004748 10884523006056 10884523006124 Lots P0A1388KY P0A1389KSY P0A1497KY P0A1498KSY P0B1081KY P0B1082KY P0B1083KSY P0B1188KY P0B1189KY P0B1339KY P0B1340KY P0B1460KY P0B1461KY P0B1462KY P0B1494KY P0B1495KY P0B1496KY P0C1183KY P0C1344KY P0C1345KY P0C1346KSY P0C1544KSY P0D0105KY P0D0106KY P0D1244KY P0D1313KY P0D1314KY P0D1315KY P0D1412KY P0D1413KY P0D1415KSY P0E0004KY P0E0005KY P0E1255KSY P0E1273KY P0E1274KY P0E1275KY P0E1276KY P0E1387KSY P0F0198KY P0F0199KY P0F0450KY P0F0451KY P0F0452KY P0F0836SY P0F0837SY P0G0041SY P0G0042SY P0G0063SY P0G0432Y P0G0433Y P0G0539Y P0G0540Y P0G0541Y P0G0644SY P0G0645SY P0H0014SY P0H0015SY P0H0016SY P0H0230Y P0H0377SY P0H0404SY P0H0405SY P0H0460SY P0J0002SY P0J0136Y P0J0462Y P0J0540SY P0J0546Y P0J0569Y P0J0570Y P0K0240Y P0L1268 P0L1346S P0L1416 P0M0890 P0M1733 P1A1129 P1C1850 P1E0212 P1F1430 P1F1573 P1G0777 P1G1144 P1J0290 P1J1366 P1K0352 P1K0960 P1K1271 P1K1303 P1K1316 P1L0163 P7A0912KX P7A0913KX P7B0813KX P7B0814KX P7B0815KX P7B1044KX P7B1045KX P7C0955KX P7C1192KX P7C1193KX P7C1197KX P7E0097KX P7E0098KX P7E0433KX P7E0434KX P7E0556KX P7E0557KX P7F0820KX P7F0821KX P7F0822KX P7F0823KX P7F1281KX P7F1282KX P7F1283KQX P7F1284KQX P7F1285KQX P7G0587KX P7G0588KX P7G0589KX P7G0590KX P7G0591KX P7H1592KX P7J0973KX P7J1221KX P7J1222KX P7J1255KX P7J1256KX P7J1257KX P7J1258KX P7K1664KX P7K1665KX P7K1668KX P7L1327KX P7L1328KX P7L1329KX P7L1330KX P7M1005KX P7M1006KX P7M1020KX P7M1021KX P8A1319KX P8B1259KX P8C1066KX P8C1081KX
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.