Ti-Cron Coated Braided Polyester Suture Product Description 88862775-31 TICRON* 4-0 BLU 75CM CV...
FDA Device Recall #Z-1181-2023 — Class II — December 2, 2022
Recall Summary
| Recall Number | Z-1181-2023 |
| 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 | 40152 units |
Product Description
Ti-Cron Coated Braided Polyester Suture Product Description 88862775-31 TICRON* 4-0 BLU 75CM CV327DA 88862880-41 TICRON* 3-0 WHI 75CM Y31DA 88863012-61 TICRON* 0 BLU 90CM C16 X36 88863015-61 TICRON* 0 BLU 120CM V20X36 88863017-51 TICRON* 2-0 BLU 120CM SKX36 88863026-71 TICRON* 1 BLU 75CM HOS12X36 88863035-51 TICRON 2-0 BLU 105CM CV305DA 88863047-41 TICRON* 3-0 BLU 45CM C13X36 88863048-51 TICRON* 2-0 BLU 75CM C13X36 88863050-61 TICRON* 0 BLU 75CM C14 X36 88863054-51 TICRON* 2-0 BLU 75CM C17X36 88863056-89 TICRON* 5 BLU 45CM GS18X12 88863059-53 TICRON* 2-0 BLU 45CM P24X12 88863070-51 TICRON* 2-0 BLU 75CM C15X36 88863088-51 TICRON* 2-0 BLU 75CM Y5X36 88863090-51 TICRON 2-0 BLU 75CM GS21X36 88863092-71 TICRON* 1 BLU 75CM KV37X36 88863109-43 TICRON* 3-0 BLU 45CM P22X12 88863111-79 TICRON* 5 BLU 75CM HGS21X36 88863119-61 TICRON* 0 BLU 75CM KV34X36 88863154-09 TICRON* 4 BLU 75CM GS11X36 88863159-31 TICRON* 4-0 BLU 90CM KV5DA 88863160-41 TICRON* 3-0 BLU 90CM Y31DA 88863163-61 TICRON* 0 BLU 75CM SC1 X36 88863185-41 TICRON* 3-0 BLU 75CM CV305 88863186-41 TICRON* 3-0 BLU 75CM CV331 88863212-51 TICRON* 2-0 BLU 90CM Y5DA7P 88863226-41 TICRON* 3-0 BLU 60CM CV330DA 88863280-21 TICRON* 5-0 BLU 75CM CV301DA 88863280-31 TICRON* 4-0 BLU 75CM CV301DA 88863309-71 TICRON* 1 BLU 75CM GS11X36 88863369-31 TICRON* 4-0 BLU 90CM CV316DA 88863393-51 TICRON* 2-0 BLU 90CM CV300DA CD-3123K TICRON* 5-0 WHI 45CM SS24 DA
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: 20884521062303, 20884521059570, 20884521060101, 20884521059006, 20884521059396, 20884521060682, 20884521059013, 10884521059290, 20884521059297, 20884521059280, 10884521061194, 20884521061191, 20884521062327, 20884521059204, 20884521060637, 20884521105192, 20884521062921, 10884521058620, 20884521058627, 20884521060170, 20884521059471, 10884521061293, 20884521061290, 20884521061641, 20884521059020, 10884521060432, 20884521060439, 20884521104300, 20884521063034, 20884521062655, 10884521062320, 10884521059900, 20884521059907, 20884521060361, 20884521059372, 20884521059990, 20884521060095, 20884521059464, 20884521062488, 10884521061507, 20884521061504. Model Number Lot # 8886277531 D1M0276Y 8886288041 D1L1698Y 8886301261 D1D3149FY 8886301561 D1E1922Y 8886301751 D2A0889Y 8886302671 D2C1802Y 8886303551 D1L0984Y 8886304741 D1G1844FY 8886304851 D1G0895FY 8886305061 D2C1969FY 8886305451 D1D3218FY 8886305689 D2D0199Y 8886305953 D1M1287FY 8886307051 D1D2540FY 8886308851 D2B2868Y 8886309051 D2B1332Y 8886309271 D2C2450Y 8886310943 D2C2451FY 8886311179 D1D2597Y 8886311961 D1M1166Y 8886315409 D2B2884Y 8886315931 D2B0542Y 8886316041 D1L1697Y D2B0543Y 8886316361 D1E0506Y 8886318541 D1J1639Y D1M2717Y D1M2851Y 8886318641 D1M2844Y D2A0933Y D2E0947Y D2E1925Y 8886321251 D2E3008Y 8886322641 D2A0451Y 8886328021 D1D0290Y 8886328031 D1L0721Y D1L2169Y D2B2861Y 8886330971 D2D2188Y 8886336931 D2B2738Y D2E0660Y D2F0767Y 8886339351 D1M0107Y D1M1299Y CD3123K D2B2213Y
Other Recalls from Covidien, LP
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2281-2026 | Class II | Covidien EndoStitch" Polysorb Single Use Loadin... | Apr 15, 2026 |
| Z-0485-2026 | Class II | Covidien Signia" Small Diameter Curved Tip Inte... | Sep 25, 2025 |
| Z-0486-2026 | 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.