Masks, Gloves & PPE recalls

450 medical device recalls in the masks, gloves & ppe category are on file with the FDA, from 2012 to 7 Oct 2026.

Total recalls450since 2012

Last 12 months14reported

Class I7216% of total

Ongoing109latest 7 Oct 2026

Recalls per month, last 24 months

click a bar for that month

2Nov '24 2 1 0Feb 0 0 0May 1 0 0Aug 6 0 1Nov 2 1 1Feb 0 0 1May 1 4 0Aug 0 3

Severity split

Class I 72 16%Class II 373 83%Class III 5 1%

Why masks, gloves & ppe is recalled

Companies

Stradis Healthcare4710%
Vyaire Medical4310%
Cardinal Health378%
American Medical Systems Innovation Center - Silicon Valley225%
ConvaTec184%
Cardinal Health 200174%
Stryker Instruments Div. of Stryker133%
Sun Med133%

By year

2026112%
2025112%
2024348%
2023184%
2022204%
2021368%
20206815%
201982%
20187016%
2017337%

Ongoing masks, gloves & ppe recalls

109 active

Reported	Class	Recall	Company	Reason	Where
7 Oct 2026Device	CLASS II	Opportunity Pro recalled by American Nitrile Operations	American Nitrile Operations	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Opportunity Flex recalled by American Nitrile Operations	American Nitrile Operations	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Performance Pro recalled by American Nitrile Operations	American Nitrile Operations	Device Malfunction	Nationwide
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

All masks, gloves & ppe recalls, newest first

450 total

Reported	Class	Recall	Company	Reason	Where
7 Oct 2026Device	CLASS II	Opportunity Pro recalled by American Nitrile Operations	American Nitrile Operations	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Opportunity Flex recalled by American Nitrile Operations	American Nitrile Operations	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Performance Pro recalled by American Nitrile Operations	American Nitrile Operations	Device Malfunction	Nationwide
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
13 May 2026Device	CLASS II	Medline Convenience Kits: PPE KIT recalled by Medline Industries	Medline Industries	Sterility	Nationwide
25 Feb 2026Device	CLASS II	Medline Convenience Kits: PPE KIT recalled by Medline Industries	Medline Industries	Sterility	Nationwide
14 Jan 2026Device	CLASS II	Medline Hudson Rci Medium Concentration Oxygen Masks recalled	Medline Industries	Other	Nationwide
31 Dec 2025Device	CLASS II	The Stryker CranialMask Tracker is a single-use device recalled	Howmedica Osteonics	Device Malfunction	Nationwide
17 Dec 2025Device	CLASS II	ChemoPlus gowns recalled by Cardinal Health 200	Cardinal Health 200	Labeling Errors	Nationwide
19 Nov 2025Device	CLASS I	Anesthesia Circuit Kits and other various kits that contain recalled	Medline Industries	Packaging Defects	Nationwide
10 Sep 2025Device	CLASS II	Smiths Medical CADD" Yellow Medication Cassette Reservoir recalled	ICU Medical	Foreign Material	MN
10 Sep 2025Device	CLASS II	Smiths Medical CADD" Medication Cassette Reservoir recalled	ICU Medical	Foreign Material	MN
10 Sep 2025Device	CLASS II	Smiths Medical CADD Medication Cassette Reservoir recalled	ICU Medical	Foreign Material	MN
10 Sep 2025Device	CLASS II	Smiths Medical NRFit CADD Yellow Medication Cassette recalled	ICU Medical	Foreign Material	MN
10 Sep 2025Device	CLASS II	Smiths Medical CADD Medication Cassette Reservoir recalled	ICU Medical	Foreign Material	MN
10 Sep 2025Device	CLASS II	Smiths Medical CADD Medication Cassette Reservoir recalled	ICU Medical	Foreign Material	MN
11 Jun 2025Device	CLASS I	Adult Manual Resuscitator with Medium Adult Mask recalled	SunMed Holdings	Device Malfunction	Nationwide
22 Jan 2025Device	CLASS II	Econo Sterile medical procedure kits labeled as recalled	Sklar Instruments	Sterility	Nationwide
18 Dec 2024Device	CLASS II	Convertor Isolation Gown, AAMI Level 3 protection recalled	Cardinal Health 200	Other	Nationwide
18 Dec 2024Device	CLASS II	Cardinal Health SMS Elastic Cuff Thumbhook Level recalled	Cardinal Health 200	Other	Nationwide
20 Nov 2024Device	CLASS II	Halyard Upper Extremity Pack - Medical convenience kits recalled	Avid Medical	Foreign Material	Nationwide
6 Nov 2024Device	CLASS II	Flex Extenders, 5.2" OD ID recalled by Westmed	Westmed	Packaging Defects	30 states
23 Oct 2024Device	CLASS I	Jaco assistive robot recalled by Kinova	Kinova	Packaging Defects	Nationwide
16 Oct 2024Device	CLASS II	Inspire Model 4063 Stimulation Lead, component of the Inspire Upper recalled	Inspire Medical Systems	Labeling Errors	Nationwide
2 Oct 2024Device	CLASS II	Silver-Plated Copper Sims Uterine Sound recalled by CooperSurgical	CooperSurgical	Other	Nationwide
18 Sep 2024Device	CLASS II	Transcend Econo Kit (UB) - Singles recalled by Ultradent Products	Ultradent Products	Particulate Matter	35 states

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.