EEA Autosuture Circular Stapler with DST Series Technology, 25mm
Medical device recall Z-1322-2022. Published in FDA’s Enforcement Report on Jul 13, 2022.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jul 13, 2022. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 433,560 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
EEA Autosuture Circular Stapler with DST Series Technology, 25mm. Model Numbers EEA25, EEAXL25, EEA2535, and EEAXL2535.
433,560, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI-DI (GTIN): 10884523004731 10884523004748 10884523006056 10884523006124 Lots P0A1388KY P0A1389KSY P0A1497KY P0A1498KSY P0B1081KY P0B1082KY P0B1083KSY P0B1188KY P0B1189KY P0B1339KY P0B1340KY P0B1460KY P0B1461KY P0B1462KY P0B1494KY…
Every code shown here, 1,996 characters
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…
FDA’s list runs to 5,115 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide distribution - US Nationwide.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on May 13, 2022.
- FDA classified it on Jul 1, 2022.
- FDA’s Enforcement Report published it on Jul 13, 2022.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Covidien, LP, of North Haven, CT.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 5,115 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.