DeviceSignal · Recall classified
Covidien, LP
FDA classified a device recall on 2026-08-07 · Class II · Z-2921-2026
EventRecall classified
Effective2026-08-07
ClassificationClass II
On 2026-08-07 the FDA classified a device recall from Covidien, LP as Class II. Product: Surgipro SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X36 SP-623. Recall Z-2921-2026. The firm initiated it on 2026-06-24. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-2921-2026
- Classification
- Class II
- Classified on
- 2026-08-07
- Initiated on
- 2026-06-24
- Firm
- Covidien, LP
- Reason
- Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.
- Product
- Surgipro SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X36 SP-623
Every field above is as fda_device_enforcement published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_enforcement
- Source record
Z-2921-2026- Snapshot hash
ab5ada73bf212eb52a548aab0968a0fcee42807c61b0350e60e24bb6e2beed72- Source URL
- https://download.open.fda.gov/device/enforcement/device-enforcement-0001-of-0001.json.zip
- Observed
- 2026-09-08T16:22:09.483Z
- Transform
fda_device_enforcement_to_recall v1- Event rule
fda_device_recall_classified v1- Event key
a190276bf5649fc0bbd13fa168314084e7cb44c7ab2c2a11b4e7d32968863d6c- Signal type
device_recall.classified
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)