Data Foundry

Medical device recalls 2023

Novafil Monofilament Polybutester Suture Product Description: 8886… — Class II medical device recall Z-1175-2023

Ongoing recall by Covidien, LP, reported 2023-03-08, distributed nationwide. Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases

Recall numberZ-1175-2023
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmCovidien, LP, North Haven, CT, United States
Recall initiated2022-12-02
Classified2023-02-25
Reported by FDA2023-03-08
DistributedNationwide (US)
Countries outside the USAE, AR, AT, AU, BE, BG, BR, CA, CH, CL, CN, CO, CZ, DE, DK, EG, ES, FI, FR, GB, GH, GR, HK, HR, HU, ID, IE, IL, IN, IQ, IR, IT, JO, JP, KE, KR, KW, LB, LT, LV, MA, MT, MX, MY, NL, NO, NZ, PA, PH, PK, PL, PT, PY, RO, RS, SA, SE, SG, SI, SK, TH, TN, TR, TW, UA, UY, VN, ZA
Quantity48,492 units
Reason classessterility
UPC / GTIN / UDI-DI10884521100091, 10884521100299, 10884521100893, 10884521118348, 10884521118393, 20884521099477, 20884521099569, 20884521099583, 20884521099682, 20884521099699, 20884521099910, 20884521099965, 20884521100074, 20884521100098, 20884521100296, 20884521100593, 20884521100692, 20884521100760, 20884521100777, 20884521100791, 20884521100814, 20884521100821, 20884521100838, 20884521100876, 20884521100890 and 3 more
Lot numbers8886400241, 8886440013, 8886440023, 8886440123, 8886440233, 8886440333, 8886441003, 8886441013, 8886442243, 8886442451, 8886445041, 8886445251, 8886445961, 8886447081, 8886458253, D1B2811FY, D1D0295Y, D1D0529Y, D1D2485FY, D1D2674FY, D1D2709FY, D1D3190Y, D1E0843Y, D1E1240FY, D1G1762FY, D1L0169FY, D1L3389Y, D1M0369FY, D1M0796FY, D1M0797Y, D1M1007FY, D1M1024FY, D1M2364FY, D2A0461Y, D2A0500FY, D2A0529Y, D2B0773FY, D2B1686FY, D2B2109Y, D2C0582Y and 12 more
Model numbers8886400241, 8886440013, 8886440023, 8886440123, 8886440233, 8886440333, 8886441003, 8886441013, 8886442243, 8886442451, 8886445041, 8886445251, 8886445961, 8886447081, 8886458253, D1B2811FY, D1D0295Y, D1D0529Y, D1D2485FY, D1D2674FY, D1D2709FY, D1D3190Y, D1E0843Y, D1E1240FY, D1G1762FY and 27 more

Product

Novafil Monofilament Polybutester Suture Product Description: 8886 4002-41 NOVAFIL 3-0 BLU 90CM C14 8886 4400-13 NOVAFIL 6-0 BLU 45CM SBE2 8886 4400-23 NOVAFIL 5-0 BLU 45CM SBE2 8886 440123 NOVAFIL 5-0 BLU 45CM SBE3 8886 4402-33 NOVAFIL 4-0 BLU 45CM SBE4 8886 4403-33 NOVAFIL 4-0 BLU 45CM SBE6 8886 4410-13 NOVAFIL 6-0 BLU 45CM P10 8886 4410-03 NOVAFIL 7-0 BLU 45CM P10 8886 4422-43 NOVAFIL 3-0 BLU 45CM C14 8886 4424-51 NOVAFIL 2-0 BLU 75CM C16 8886 4450-41 NOVAFIL 3-0 BLU 75CM V26 8886 4452-51 NOVAFIL 2-0 BLU 75CM V20 8886 4459-61 NOVAFIL 0 BLU 75CM GS22 8886 4470-81 NOVAFIL* 2 BLU 150CM GS26 8886 4582-53 NOVAFIL* 2-0 BLU 75CM P14 SPB-1213G NOVAFIL* 6-0 BLU 45CM P13X12 SPB-1233G NOVAFIL* 4-0 BLU 45CM P13X12 SPB-1623G NOVAFIL* 5-0 BLU 45CM P12X12 SPB-5142G NOVAFIL* 5-0 BLU 45CM P11X12 SPB-5143G NOVAFIL* 4-0 BLU 45CM P11X12 SUT SPB-5223G NOVAFIL 5-0 BLU 45CM P13 SPB-5433G NOVAFIL* 4-0 CLR 45CM P24X12 SPB-5633G NOVAFIL* 4-0 BLU 45CM P12X12

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1175-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.