• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall EEA Autosuture Circular Stapler

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
  Class 2 Device Recall EEA Autosuture Circular Stapler see related information
Date Initiated by Firm May 13, 2022
Create Date July 01, 2022
Recall Status1 Open3, Classified
Recall Number Z-1322-2022
Recall Event ID 90362
Product Classification Stapler, surgical - Product Code GAG
Product EEA Autosuture Circular Stapler with DST Series Technology, 25mm. Model Numbers EEA25, EEAXL25, EEA2535, and EEAXL2535.
Code Information 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 P8C1082KX P8C1083KX P8C1084KX P8C1630KX P8C1631KX P8C1632KX P8D1295KX P8D1554KX P8D1555KX P8D1556KX P8E1043KX P8E1553KX P8E1554KX P8F1303KX P8F1304KX P8G0365KQX P8G0366KX P8G0560KX P8H1175KX P8H1176KX P8H1177KX P8H1178KX P8H1311KX P8H1621KX P8H1622KX P8H1623KX P8K1790KY P8K1791KY P8L0996KY P8L1249KSY P8L1283KY P8L1374KY P8L1375KY P8L1606KY P8M1080KY P8M1081KY P8M1082KY P9A1519KY P9A1520KY P9A1521KY P9A1522KY P9A1523KY P9A1637KQY P9A1638KY P9B1276KQY P9B1277KY P9B1278KY P9B1524KSY P9B1525KSY P9B1526KY P9C1517KY P9C1518KY P9C1711KY P9D1135KY P9D1136KQY P9D1227KY P9D1228KY P9D1523KY P9E0912KY P9E0945KY P9E1261KY P9E1309KY P9E1310KY P9E1311KY P9F1185KY P9F1186KY P9F1187KY P9F1188KY P9F1189KY P9H1248KY P9H1249KY P9J0361KY P9J0402KY P9J0403KY P9J1219KY P9J1220KY P9J1221KY P9K1363KY P9K1364KY P9K1365KY P9L1117KSY P9L1118KSY P9L1240KSY P9M0010KY P9M1253KY P9M1254KY P9M1330KSY P9M1331KSY P9M1404KY P9M1405KY P9M1595KY P9M1596KY P9M1695KY P9M1696KY P0A1134KY P0B1490KY P0C1177KSY P0C1349KY P0C1350KY P0C1545KY P0D1245KSY P0D1270KY P0D1271KY P0D1299KY P0E1305KY P0F0362KY P0F0363KY P0F0989Y P0G0610Y P0H0017Y P0H0018Y P0J0128Y P0J0356SY P0J0478Y P0J0530Y P0K0206Y P0M1710 P1A0618S P1B0317 P1B0318 P1C1626 P1K0350 P1L0902 P7B0046KX P7B0563KX P7B1048KX P7B1049KX P7C0024KX P7E0650KX P7E0651KX P7H1414KX P7H1593KX P7H2033KX P7J1259KX P7J1260KX P7K1669KX P7K1671KX P7L0263KRX P7L1165KX P7L1331KX P7L1332KX P8A1314KX P8B1454KX P8D1383KX P8D1384KX P8E0103KX P8E0104KX P8F1075KX P8F1076KX P8F1308KX P8G0552KQX P8G0553KQX P8G1318KX P8J1331KX P8J1335KX P8L1594KY P8M1083KY P9C1460KY P9C1461KY P9C1596KY P9C1712KY P9D1383KY P9E0941KY P9F0033KY P9F0034KY P9F1239KY P9F1240KY P9H0969KY P9H0970KY P9J0890KSY P9K0716KY P9K0717KY P9L1043KY P9L1044KY P9M1321KSY P9M1524KY P0A1261KY P0A1525KY P0B0661KY P0B1027KSY P0B1359KY P0B1493KY P0C1178KY P0C1546KY P0D1324KY P0D1417KY P0E1156KY P0E1157KY P0E1158KY P0G0538Y P0J0459SY P0K0030Y P1A1337 P1C1846 P1K0513 P7B0817KX P7B0818KX P7C1198KX P7C1199KX P7C1200KX P7E0099KX P7E0100KX P7E0399KX P7E0400KX P7E0401KX P7E0402KX P7E0652KX P7F1341KQX P7F1342KQX P7H2048KX P7H2049KX P7J1160KX P7L0183KX P7L0184KX P7L0185KX P7L1361KX P7L1362KX P7L1363KX P7M1003KX P7M1004KX P8A0662KX P8A1308KX P8B1108KX P8C1086KX P8C1087KX P8C1491KX P8C1494KX P8E1246KX P8E1247KX P8E1360KX P8F1410KX P8G1387KX P8H1187KX P8J1348KX P8K1788KY P8K1789KY P8M1358KY P9A1527KY P9A1528KY P9D1229KY P9E1115KY P9F1224KY P9F1225KY P9F1226KY P9H0014KY P9H0015KQY P9J0725KY P9K0714KY P9K0715KY P9M1406KY P9M1407KY P9M1597KY P0A1142KY P0B0666KY P0B0667KY P0B1357KY P0B1358KY P0C0481KRY P0C1179KY P0D1570KY P0E0685KY P0E1159KY P0G0434Y P0G0652Y P0H0161Y P0H0243Y P0K0205Y P0L1339 P1A1364 P1B0320 P1C1816 P1E0804 P1E1465 P1F1352 P1G1107 P1H0427 P1J0730 P1J0954 P1K0351 P7A0022KX P7B0040KX P7B0041KX P7B0564KX P7B1050KX P7B1051KX P7B1052KX P7C0697KX P7C0698KX P7C0699KX P7E0076KX P7E0077KX P7E0078KX P7E0079KX P7E0393KX P7E0394KX P7E0395KX P7E0396KX P7E0397KX P7E0398KX P7F0209KX P7F0210KX P7F0211KX P7F0817KX P7F0818KX P7F1210KX P7G0592KX P7G0593KX P7G0594KX P7G0595KX P7J1158KX P7J1159KX P7L0182KX P7L1053KX P7L1054KX P7L1055KX P7L1056KX P7L1354KX P7L1355KX P7L1356KX P7L1357KX P7L1358KX P7L1359KX P7M1256KX P7M1359KX P8A1306KX P8A1307KX P8B1109KX P8B1110KX P8B1304KX P8B1305KX P8C1088KX P8C1495KX P8C1496KX P8D1385KX P8D1386KX P8E1248KX P8E1249KX P8F1361KX P8G1265KX P8G1386KX P8J1347KX P8L1122KY P8L1123KY P8L1592KY P8L1593KY P9A1640KY P9B1352KY P9B1353KY P9C1346KY P9D1359KY P9E1116KY P9E1117KY P9E1312KY P9E1313KY P9F1227KY P9F1228KY P9H0669KY P9H0670KY P9H0963KY P9H0964KY P9J1008KY P9J1234KY P9J1235KY P9M1412KY P9M1486KY
Recalling Firm/
Covidien, LP
60 Middletown Ave
North Haven CT 06473-3908
For Additional Information Contact Medtronic Customer Service
Manufacturer 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.
FDA Determined
Cause 2
Process change control
Action Beginning 13-MAY-2022 communications to all affected consignees began. In the United States notifications are set via UPS 2-day delivery. Customers should return all unused affected product in inventory to Medtronic. Consignees are asked to forward this notification to those who need to be aware within the organization and to any location which the devices have been transferred. Consignees are asked to complete and return a confirmation certificate (or equivalent record) confirming they have received the notification.
Quantity in Commerce 433,560
Distribution Worldwide distribution - US Nationwide.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.