Home / Recalls / Covidien LP / Z-0844-2024

Z-0844-2024 Class II Ongoing

Recalled by Covidien LP — Mansfield, MA

FDA device recall Z-0844-2024 was initiated by Covidien LP on December 21, 2023 and is designated Class II. Reason for recall: Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma levels may decrease the strength of the sutures over time, which could result in harms such … The recall status is ongoing. Affected quantity: 46,812 US; 68,976 OUS.

Recall Details

Product Type
Devices
Report Date
February 7, 2024
Initiation Date
December 21, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
46,812 US; 68,976 OUS

Product Description

Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT 88861919-51 SURGILON* 2-0 BLK 7X75CMPCT 88861919-71 SURGILON* 1 BLK 7X75CM PCT

Reason for Recall

Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma levels may decrease the strength of the sutures over time, which could result in harms such as wound dehiscence and hemorrhage/blood loss/ bleeding at a critical level.

Distribution Pattern

Worldwide US Nationwide distribution including in the states of AL, AZ, CA, FL, GA, HI, IA, IL, IN, MD, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OK, OR, PA, PR, TN, TX, VA, WA, WV and the countries of Australia, Bahrain, Belgium, Bulgaria, Canary Islands, China, Cyprus, Czech Republic, Finland, France, Germany, Greece, Hong Kong, Hungary, Italy, Japan, Korea, Republic Of Kosovo, Mongolia, Netherlands, New Zealand, Panama, Poland, Portugal, Puerto Rico, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom.

Code Information

Model 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT UDI-DI 10884521071728, 20884521071725 Lots D1L1929RY D2B2243RY Model 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT UDI-DI 10884521071742, 20884521071749 Lot D2B0176RY Model 88861919-51 SURGILON* 2-0 BLK 7X75CMPCT UDI-DI 10884521071766 Lots D2D2437RY UDI-DI 20884521071763 Lots D2D2437RY D2E0905RY D2E0916RY Model 88861919-71 SURGILON* 1 BLK 7X75CM PCT UDI-DI 20884521071794 Lots D1M0640RY D1M1494RY

Other recalls by Covidien LP

  • Z-2919-2026 Class II — V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX (June 24, 2026)
  • Z-2921-2026 Class II — Surgipro SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X36 SP-623 (June 24, 2026)
  • Z-2922-2026 Class II — Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX (June 24, 2026)
  • Z-2920-2026 Class II — Dermalon 88861757-31 DERMALON* 4-0 BLU 75CM C13 88861757-31 88861799-31 (June 24, 2026)
  • Z-2918-2026 Class II — V-Loc 90 Absorbable Wound Closure Device VLOC 90 0 VL 22 GS-21 VLOCM0336 (June 24, 2026)
  • Z-2272-2026 Class II — Covidien Mon-a-Therm General Purpose Temperature Probe REF: 90044 (April 23, 2026)
  • Z-2273-2026 Class II — Covidien Mon-a-Therm general purpose temperature probe size: 9 Fr REF: 90050 (April 23, 2026)
  • Z-2653-2026 Class II — Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code: 108845220 (April 23, 2026)
  • Z-2271-2026 Class II — Covidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM REF: (April 23, 2026)
  • Z-2281-2026 Class II — Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 (April 15, 2026)

FDA data resources