CLASS II ONGOING Device recall · Reported 19 Aug 2026 · FDA Enforcement Report

Surgipro II S8698GX Surgipro II BL 5/0 18 P-13 S8698GX recalled

Covidien is recalling Surgipro II S8698GX Surgipro II BL 5/0 18 P-13 S8698GX, distributed nationwide in the US. The recall was initiated on 24 Jun 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesS8698GX UDI-DI 20612479214716 Lot D5M3438FY

Quantity recalled135,875 total

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-2922-2026
FDA event ID: 99390
Recalling firm: Covidien, North Haven, CT
Classification: Class II
Status: Ongoing
Recall initiated: 24 Jun 2026
FDA classified: 7 Aug 2026
Reported: 19 Aug 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

24 Jun 2026	Recall initiated by company
7 Aug 2026	Classified by FDA	+44 days
19 Aug 2026	Published in enforcement report	+12 days

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

Reason for recall

Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.

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

Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX

Where it was distributed

US Nationwide and the countries of Australia, Austria, Belgium, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Guadeloupe, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kosovo, Lebanon, Lithuania, Luxembourg, Mexico, Namibia, Netherlands, North Macedonia, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

S8698GX UDI-DI 20612479214716 Lot D5M3438FY

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

4 other products · FDA event 99390

This product is part of a recall event; the main page for the event is V-Loc 180 Absorbable Wound Closure Device Box Bedside recalled.

Reported	Class	Recall	Company	Reason	Where
19 Aug 2026	CLASS II	V-Loc 180 Absorbable Wound Closure Device Box Bedside recalled	Covidien	Sterility	Nationwide
19 Aug 2026	CLASS II	V-Loc 90 Absorbable Wound Closure Device Vloc 90 0 VL recalled	Covidien	Sterility	Nationwide
19 Aug 2026	CLASS II	Surgipro SP-623 Surgipro* 2-0 BLU SC2 X36 SP recalled by Covidien	Covidien	Sterility	Nationwide
19 Aug 2026	CLASS II	Dermalon 88861757-31 Dermalon* 4-0 Blu C13 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	V-Loc 180 Absorbable Wound Closure Device Box Bedside recalled	Covidien	Sterility	Nationwide

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide