CLASS III ONGOING Device recall · Reported 15 Feb 2023 · FDA Enforcement Report

Fluidshield 3 Fog-Free Procedure Mask recalled

Owens & Minor Distribution is recalling Fluidshield 3 Fog-Free Procedure Mask with SO Soft Lining and SO Soft Earloops, Orange, distributed in Illinois, North Carolina, New York, Ohio, Pennsylvania. The recall was initiated on 3 Jan 2023 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesUDI-DI 20680651471479 Lot AM2222041 Expiration Date 2027-08-10

Quantity recalled73 cases

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-1059-2023
FDA event ID: 91530
Recalling firm: Owens & Minor Distribution, Mechanicsville, VA
Classification: Class III
Status: Ongoing
Recall initiated: 3 Jan 2023
FDA classified: 3 Feb 2023
Reported: 15 Feb 2023
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Labeling Errors
Device type: Masks, Gloves & PPE

Timeline

3 Jan 2023	Recall initiated by company
3 Feb 2023	Classified by FDA	+31 days
15 Feb 2023	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

Face masks were placed into the incorrect dispenser boxes. The face masks come with ear loops, but the dispenser is incorrectly labeled as face masks with ties instead of ear loops.

Product as listed by the FDA

FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAround Visor Product Code 47147

Where it was distributed

US distribution to IL, NC, NY, OH, and PA.

Illinois North Carolina New York Ohio Pennsylvania

Questions about this recall

Why was it recalled?

Face masks were placed into the incorrect dispenser boxes. The face masks come with ear loops, but the dispenser is incorrectly labeled as face masks with ties instead of ear loops.

Which lots are affected?

UDI-DI 20680651471479 Lot AM2222041 Expiration Date 2027-08-10

Where was it sold?

US distribution to IL, NC, NY, OH, and PA.

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 III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

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.

More recalls from Owens & Minor Distribution

All 8

Reported	Class	Recall	Company	Reason	Where
7 Dec 2022Device	CLASS II	Aero Blue Performance Surgical Gown, XL- Sterile surgical gown recalled	Owens & Minor Distribution	Sterility	IL, IN, WV
28 Dec 2016Device	CLASS II	Medi Choice Arm Slings Asl 2103 Small 1/EA recalled	Owens & Minor Distribution	Processing Deviation	Nationwide
10 Feb 2016Device	CLASS II	MediChoice Cohesive Bandages recalled by Owens & Minor Distribution	Owens & Minor Distribution	Sterility	Nationwide
10 Feb 2016Device	CLASS II	MediChoice Cohesive Bandages recalled by Owens & Minor Distribution	Owens & Minor Distribution	Sterility	Nationwide
10 Feb 2016Device	CLASS II	MediChoice Cohesive Bandages recalled by Owens & Minor Distribution	Owens & Minor Distribution	Sterility	Nationwide

Other Masks, Gloves & PPE recalls

All 447

Reported	Class	Recall	Company	Reason	Where
29 Jul 2026Device	CLASS II	P28 Phanton Intramedullary Nail System recalled by Paragon 28	Paragon 28	Sterility	Nationwide
8 Jul 2026Device	CLASS II	Cyberknife Treatment Deliver System equipped recalled	Accuray	Device Malfunction	Nationwide
8 Jul 2026Device	CLASS II	Adapter for Head Positioning recalled by Baxter Healthcare	Baxter Healthcare	Other	Nationwide
8 Jul 2026Device	CLASS II	Cyberknife Treatment Deliver System equipped recalled	Accuray	Device Malfunction	Nationwide
3 Jun 2026Device	CLASS II	Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference recalled	O&M Halyard	Other	Nationwide