Recall Z-2921-2026
Covidien, LP · initiated June 24, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Surgipro SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X36 SP-623
Codes / lots: SP-623 UDI-DI 20884521037073 Lot D6A2963Y
Reason for recall
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.
FDA-determined cause: Equipment maintenance
Action taken
The firm began notifying consignees on 7/7/26 via email, mail, or electronically. Notices were titled, "URGENT: VOLUNTARY MEDICAL DEVICE RECALL." Customers were informed of the manufacturing nonconformance. If products in scope of this field action have been used in patients under the customer's care, the customer is instructed to monitor for signs of infection or vision issues due to the possibility of biocontamination. Customers were instructed to immediately identify, cease use, and quarantine all unused impacted product. Unused impacted product is to be returned to Medtronic. The recall notice should be passed on to all those who need to be aware within the customer's organization or to any organization where devices have been transferred.
Details
- Recall number
- Z-2921-2026
- Initiated
- June 24, 2026
- Posted by FDA
- August 7, 2026
- Product code
- GAW – Suture, Nonabsorbable, Synthetic, Polypropylene
- Quantity
- 135,875 total
- Distribution
- US Nationwide and the countries of Australia, Austria, Belgium, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Guadeloupe, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kosovo, Lebanon, Lithuania, Luxembourg, Mexico, Namibia, Netherlands, North Macedonia…
- Recalling firm
- Covidien, LP, North Haven, CT
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2918-2026 Class II | V-Loc 90 Absorbable Wound Closure Device VLOC 90 0 VL 22 GS-21 VLOCM0336 VLOC 90 0 VL 22…Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in… | 06/24/2026Open, Classified |
| Z-2919-2026 Class II | V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX06614V4 BOX BY…Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in… | 06/24/2026Open, Classified |
| Z-2920-2026 Class II | Dermalon 88861757-31 DERMALON* 4-0 BLU 75CM C13 88861757-31 88861799-31 DERMALON* 4-0…Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in… | 06/24/2026Open, Classified |
| Z-2922-2026 Class II | Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GXProduct may contain a perforation or tear in the sterile barrier packaging. This issue may result in… | 06/24/2026Open, Classified |