Surgilon Braided Nylon suture Product Description: 88861883-51 SURGILON* 2-0 BLK 75CM C16 8886...
FDA Device Recall #Z-1178-2023 — Class II — December 2, 2022
Recall Summary
| Recall Number | Z-1178-2023 |
| Classification | Class II — Moderate risk |
| Date Initiated | December 2, 2022 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Covidien, LP |
| Location | North Haven, CT |
| Product Type | Devices |
| Quantity | 87708 units |
Product Description
Surgilon Braided Nylon suture Product Description: 88861883-51 SURGILON* 2-0 BLK 75CM C16 88861915-71 SURGILON* 1 BLK 75CM GS11 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT 88861919-51 SURGILON* 2-0 BLK 7X75CMPCT 88861919-61 SURGILON* 0 BLK 7X75CM PCT 88861919-71 SURGILON* 1 BLK 7X75CM PCT 88861932-51 SURGILON* 2-0 BLK 75CM GS10 88861971-71 SURGILON* 1 BLK 75CM GS21 88861985-71 SURGILON* 1 BLK 75CM SC1X36 SBS-1884G SURGILON* 4-0 WHI 45CM P12X12 SBS-1928G SURGILON* 5-0 BLK 45CM P13X12
Reason for Recall
Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
Distribution Pattern
US Nationwide Distribution and OUS Foreign distribution to countries of: Albania Argentina Armenia Australia Austria Azerbaijan Belarus Belgium Bosnia And Herzegovina Brazil Bulgaria Cambodia Cameroon Canada Canary Islands Chile China Colombia Croatia Czech Republic Denmark Egypt Finland France Georgia Germany Ghana Greece Hong Kong Hungary India Indonesia Iran Iraq Ireland Israel Italy JAPAN Jordan Kazakhstan Kenya Korea, Republic Of Kosovo Kuwait Latvia Lebanon Lithuania Macao Malaysia Malta Mauritius Mexico Moldova, Republic Of Morocco Myanmar Namibia Netherlands New Zealand North Macedonia Norway Pakistan Panama Paraguay Philippines Poland Portugal Reunion Romania Russian Federation Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Syrian Arab Republic Taiwan Thailand Tunisia Turkey Uganda Ukraine United Arab Emirates United Kingdom Uruguay Uzbekistan Viet Nam Zimbabwe
Lot / Code Information
GTIN: 20884521073996, 20884521076652, 10884521072183, 20884521072180, 10884521071223, 20884521071220, 10884521071797, 20884521071794, 20884521071763, 20884521071787, 20884521071749, 10884521073838, 20884521073835, 20884521076669, 10884521076662, 10884521071766, 20884521071725, 10884521071513, 20884521071510. Model Number Lot # 8886188351 D1K1677FY 8886191571 D2C3242Y 8886191931 D2B2243Y 8886191941 D1M2553Y D1M2561Y D2B0169Y 8886191951 D1M0915Y D2A0560Y D2B1245Y D2B1537Y D2B2751Y D2C0267Y D2C0907Y D2C1101Y D2D2347Y D2D2437Y D2D2506Y D2D2510Y D2E0905Y 8886191961 D1M1423Y D2A0861Y D2A0865Y D2A1709Y D2B1349Y D2B1350Y D2B2727Y 8886191971 D1M0640Y D1M1494Y D2C0962Y 8886193251 D1G1867Y 8886197171 D2B0290Y D2B0445Y D2B0476Y 8886198571 D1E0626Y SBS1884G D1E1212FY SBS1928G D2B0707FY D2C3247FY
Other Recalls from Covidien, LP
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2281-2026 | Class II | Covidien EndoStitch" Polysorb Single Use Loadin... | Apr 15, 2026 |
| Z-0486-2026 | Class II | Covidien Signia" Small Diameter Curved Tip Inte... | Sep 25, 2025 |
| Z-0485-2026 | Class II | Covidien Signia" Small Diameter Curved Tip Inte... | Sep 25, 2025 |
| Z-1891-2024 | Class II | Tri-Staple 2.0 Black Reinforced Intelligent Rel... | Apr 15, 2024 |
| Z-1470-2024 | Class II | Covidien Auto Suture" Blunt Tip Trocar, Product... | Feb 28, 2024 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.