CLASS II ONGOING Device recall · Reported 8 Mar 2023 · FDA Enforcement Report

8886 4002-41 Novafil 3-0 Blu C14 8886 4400-13 Novafil recalled

Covidien is recalling 8886 4002-41 Novafil 3-0 Blu C14 8886 4400-13 Novafil 6-0 Blu Sbe2 8886 4400-23 Novafil, distributed nationwide in the US. The recall was initiated on 2 Dec 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesGTIN 20884521100821, 20884521100098, 10884521100091, 10884521100299, 20884521100296, 20884521099910, 20884521100814, 20884521100791, 20884521100593, 20884521099965, 20884521099477, 20884521100760, 20884521118345, 10884521118348, 20884521099682, 20884521118406, 20884521099699, 20884521100838, 20884521099699, 20884521118390, 10884521118393, 20884521100890, 10884521100893, 20884521099569, 20884521100692, 20884521100074, 20884521099583, 20884521100876, 20884521100777. Model # Lot #: 8886400241 D1G1762FY, 8886440013 D2A0461Y, 8886440023 D1M0797Y, 8886440123 D1L3389Y, 8886440233 D2A0529Y, 8886440333 D2C0582Y, 8886441003 D1M1007FY, D1M2364FY 8886441013 D1M1007FY D1M2364FY, 8886441003 D1M0369FY D1M0796FY, 8886442243 D1D2485FY, 8886442451 D1E1240FY, 8886445041 D2B2109Y, 8886445251 D1D0295Y, D1E0843Y, 8886445961 D1D0529Y, 8886447081 D1D3190Y, 8886458253 D2B1686FY, SPB1213G D1L0169FY, D2B0773FY D2C0769FY, SPB1233G D2E0961FY, SPB1623G D1D2709FY, SPB5142G D1B2811FY, SPB5143G D1D2674FY, SPB5223G D1M1024FY, SPB5433G D2C1970FY, SPB5633G D2A0500FY, SPB-5223G D1M1024FY

Quantity recalled48492 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1175-2023
FDA event ID: 91324
Recalling firm: Covidien, North Haven, CT
Classification: Class II
Status: Ongoing
Recall initiated: 2 Dec 2022
FDA classified: 25 Feb 2023
Reported: 8 Mar 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Surgical Instruments

Timeline

2 Dec 2022	Recall initiated by company
25 Feb 2023	Classified by FDA	+85 days
8 Mar 2023	Published in enforcement report	+11 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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

Where it was distributed

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

Nationwide Georgia

Questions about this recall

Why was it recalled?

Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

Which lots are affected?

GTIN 20884521100821, 20884521100098, 10884521100091, 10884521100299, 20884521100296, 20884521099910, 20884521100814, 20884521100791, 20884521100593, 20884521099965, 20884521099477, 20884521100760, 20884521118345, 10884521118348, 20884521099682, 20884521118406, 20884521099699, 20884521100838, 20884521099699, 20884521118390, 10884521118393, 20884521100890, 10884521100893, 20884521099569, 20884521100692, 20884521100074, 20884521099583, 20884521100876, 20884521100777. Model # Lot #: 8886400241 D1G1762FY, 8886440013 D2A0461Y, 8886440023 D1M0797Y, 8886440123 D1L3389Y, 8886440233 D2A0529Y, 8886440333 D2C0582Y, 8886441003 D1M1007FY, D1M2364FY 8886441013 D1M1007FY D1M2364FY, 8886441003 D1M0369FY D1M0796FY, 8886442243 D1D2485FY, 8886442451 D1E1240FY, 8886445041 D2B2109Y, 8886445251 D1D0295Y, D1E0843Y, 8886445961 D1D0529Y, 8886447081 D1D3190Y, 8886458253 D2B1686FY, SPB1213G D1L0169FY, D2B0773FY D2C0769FY, SPB1233G D2E0961FY, SPB1623G D1D2709FY, SPB5142G D1B2811FY, SPB5143G D1D2674FY, SPB5223G D1M1024FY, SPB5433G D2C1970FY, SPB5633G D2A0500FY, SPB-5223G D1M1024FY

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

10 other products · FDA event 91324

This product is part of a recall event; the main page for the event is 88861883-51 Surgilon* 2-0 Blk C16 88861915-71 Surgilon* recalled.

Reported	Class	Recall	Company	Reason	Where
8 Mar 2023	CLASS II	88861883-51 Surgilon* 2-0 Blk C16 88861915-71 Surgilon* recalled	Covidien	Sterility	Nationwide
8 Mar 2023	CLASS II	Dermalon Monofilament Nylon Suture recalled by Covidien	Covidien	Sterility	Nationwide
8 Mar 2023	CLASS II	Us1638 Custom Suture Pack Us1756 Custom Suture Pack recalled by Covidien	Covidien	Sterility	Nationwide
8 Mar 2023	CLASS II	Ti-Cron Coated Braided Polyester Suture Product Description recalled	Covidien	Sterility	Nationwide
8 Mar 2023	CLASS II	Surgidac Uncoated Braided Polyester suture Product recalled by Covidien	Covidien	Sterility	Nationwide
8 Mar 2023	CLASS II	Sofsilk Coated Braided Silk Suture Product Description recalled	Covidien	Sterility	Nationwide
8 Mar 2023	CLASS II	Monosof Monofilament Nylon sutures recalled by Covidien	Covidien	Sterility	Nationwide
8 Mar 2023	CLASS II	Surgipro II Monofilament Polypropylene Sutures Product Description recalled	Covidien	Sterility	Nationwide
8 Mar 2023	CLASS II	Monofilament Nylon Suture (McKesson Branded) recalled by Covidien	Covidien	Sterility	Nationwide
8 Mar 2023	CLASS II	Surgipro Monofilament Polypropylene Sutures Product recalled by Covidien	Covidien	Sterility	Nationwide

More recalls from Covidien

All 493

Reported	Class	Recall	Company	Reason	Where
26 Aug 2026Device	CLASS II	EndoFLIP System that includes recalled by Covidien	Covidien	Other	Nationwide
19 Aug 2026Device	CLASS II	Dermalon 88861757-31 Dermalon* 4-0 Blu C13 recalled by Covidien	Covidien	Sterility	Nationwide
19 Aug 2026Device	CLASS II	Surgipro SP-623 Surgipro* 2-0 BLU SC2 X36 SP recalled by Covidien	Covidien	Sterility	Nationwide
19 Aug 2026Device	CLASS II	V-Loc 90 Absorbable Wound Closure Device Vloc 90 0 VL recalled	Covidien	Sterility	Nationwide
19 Aug 2026Device	CLASS II	Surgipro II S8698GX Surgipro II BL 5/0 18 P-13 S8698GX recalled	Covidien	Sterility	Nationwide

Other Surgical Instruments recalls

All 3,809

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits: IV Start KIT recalled by Medline Industries	Medline Industries	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Packaging Defects	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled	ConMed	Other	Nationwide