CLASS II Device recall · Reported 15 Jul 2015 · FDA Enforcement Report

Vaginal Rejuvenation Pack - contains Devon Light Glove Used recalled

Stradis Healthcare is recalling Vaginal Rejuvenation Pack - contains Devon Light Glove Used during surgery, distributed nationwide in the US. The recall was initiated on 20 Apr 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPack 693-222

Quantity recalledOne

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-2001-2015
FDA event ID: 71130
Recalling firm: Stradis Healthcare, Lawrenceville, GA
Classification: Class II
Status: Completed
Recall initiated: 20 Apr 2015
FDA classified: 7 Jul 2015
Reported: 15 Jul 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Masks, Gloves & PPE

Timeline

20 Apr 2015	Recall initiated by company
7 Jul 2015	Classified by FDA	+78 days
15 Jul 2015	Published in enforcement report	+8 days

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

Reason for recall

Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

Product as listed by the FDA

Vaginal Rejuvenation Pack - contains Devon Light Glove Used during surgery

Where it was distributed

Distribution US nationwide to AL, AK, CA, DE, FL, GA, HI, ID, IL, IN, KS, KY, ME, MD, MA, MI, MS, MO, NM, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA; Canada and Dubai

Nationwide Alaska Alabama California Delaware Florida Georgia Hawaii Idaho Illinois Indiana Kansas Kentucky Massachusetts Maryland Maine Michigan Missouri Mississippi North Carolina New Jersey

Questions about this recall

Why was it recalled?

Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

Which lots are affected?

Pack 693-222

Where was it sold?

Distribution US nationwide to AL, AK, CA, DE, FL, GA, HI, ID, IL, IN, KS, KY, ME, MD, MA, MI, MS, MO, NM, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA; Canada and Dubai

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

50 other products · FDA event 71130

This product is part of a recall event; the main page for the event is Lima Pack - contains Devon Light Glove Used during surgery recalled.

Reported	Class	Recall	Company	Reason	Where
15 Jul 2015	CLASS II	Lima Pack - contains Devon Light Glove Used during surgery recalled	Stradis Healthcare	Other	Nationwide
15 Jul 2015	CLASS II	Mississippi Pack - contains Devon Light Glove Used during surgery recalled	Stradis Healthcare	Other	Nationwide
15 Jul 2015	CLASS II	Arthroscopy Pack - contains Devon Light Glove Used during surgery recalled	Stradis Healthcare	Other	Nationwide
15 Jul 2015	CLASS II	Phleb Pack and Laser Phleb Pack recalled by Stradis Healthcare	Stradis Healthcare	Other	Nationwide
15 Jul 2015	CLASS II	Shoulder Pack - contains Devon Light Glove Used during surgery recalled	Stradis Healthcare	Other	Nationwide
15 Jul 2015	CLASS II	Endovenous Kit, Endo Pack and Endovenous Laser Kit recalled	Stradis Healthcare	Other	Nationwide
15 Jul 2015	CLASS II	Vasc Custom Kit - contains Devon Light Glove Used during surgery recalled	Stradis Healthcare	Other	Nationwide
15 Jul 2015	CLASS II	Skin and Vein Pack - contains Devon Light Glove Used during surgery recalled	Stradis Healthcare	Other	Nationwide
15 Jul 2015	CLASS II	Surgical Pack and General Surgery Pack recalled by Stradis Healthcare	Stradis Healthcare	Other	Nationwide
15 Jul 2015	CLASS II	Head & Neck Pack - contains Devon Light Glove Used during surgery recalled	Stradis Healthcare	Other	Nationwide
15 Jul 2015	CLASS II	Blepharoplasty Pack - contains Devon Light Glove Used during surgery recalled	Stradis Healthcare	Other	Nationwide
15 Jul 2015	CLASS II	Suction Pack - contains Devon Light Glove Used during surgery recalled	Stradis Healthcare	Other	Nationwide
15 Jul 2015	CLASS II	General Pack - contains Devon Light Glove Used during surgery recalled	Stradis Healthcare	Other	Nationwide
15 Jul 2015	CLASS II	Glaucoma Pack - contains Devon Light Glove Used during surgery recalled	Stradis Healthcare	Other	Nationwide
15 Jul 2015	CLASS II	Knee Arthro Pack and Knee Arthro Pack II recalled by Stradis Healthcare	Stradis Healthcare	Other	Nationwide
15 Jul 2015	CLASS II	Pediatric Pack - contains Devon Light Glove Used during surgery recalled	Stradis Healthcare	Other	Nationwide
15 Jul 2015	CLASS II	Custom Pack - contains Devon Light Glove Used during surgery recalled	Stradis Healthcare	Other	Nationwide
15 Jul 2015	CLASS II	Lipo Pack, Liposuction Expended Pack, and Liposuction Tray recalled	Stradis Healthcare	Other	Nationwide
15 Jul 2015	CLASS II	Standard Pack - contains Devon Light Glove Used during surgery recalled	Stradis Healthcare	Other	Nationwide
15 Jul 2015	CLASS II	Vein & Vascular Pack - contains Devon Light Glove Used recalled	Stradis Healthcare	Other	Nationwide
15 Jul 2015	CLASS II	Hand Pack - contains Devon Light Glove Used during surgery recalled	Stradis Healthcare	Other	Nationwide
15 Jul 2015	CLASS II	ENT Pack - contains Devon Light Glove Used during surgery recalled	Stradis Healthcare	Other	Nationwide
15 Jul 2015	CLASS II	Plastic Pack and Plastic HNP Pack recalled by Stradis Healthcare	Stradis Healthcare	Foreign Material	Nationwide
15 Jul 2015	CLASS II	Lipo/Buttocks Pack - contains Devon Light Glove Used during surgery recalled	Stradis Healthcare	Other	Nationwide
15 Jul 2015	CLASS II	Hand Pack - contains Devon Light Glove Used during surgery recalled	Stradis Healthcare	Other	Nationwide
15 Jul 2015	CLASS II	Vein Ablation Pack - contains Devon Light Glove Used during surgery recalled	Stradis Healthcare	Other	Nationwide
15 Jul 2015	CLASS II	Face Lift Pack - contains Devon Light Glove Used during surgery recalled	Stradis Healthcare	Other	Nationwide
15 Jul 2015	CLASS II	Podiatry Pack - contains Devon Light Glove Used during surgery recalled	Stradis Healthcare	Other	Nationwide
15 Jul 2015	CLASS II	Face Neck Pack - contains Devon Light Glove Used during surgery recalled	Stradis Healthcare	Other	Nationwide
15 Jul 2015	CLASS II	Cysto Pack - contains Devon Light Glove Used during surgery recalled	Stradis Healthcare	Other	Nationwide
15 Jul 2015	CLASS II	Upper Extremity Pack - contains Devon Light Glove Used recalled	Stradis Healthcare	Other	Nationwide
15 Jul 2015	CLASS II	Open Pack - contains Devon Light Glove Used during surgery recalled	Stradis Healthcare	Other	Nationwide
15 Jul 2015	CLASS II	Advanced Vein Care - contains Devon Light Glove Used during surgery recalled	Stradis Healthcare	Other	Nationwide
15 Jul 2015	CLASS II	DND Pack - contains Devon Light Glove Used during surgery recalled	Stradis Healthcare	Other	Nationwide
15 Jul 2015	CLASS II	Tummy Tuck Pack - contains Devon Light Glove Used during surgery recalled	Stradis Healthcare	Other	Nationwide
15 Jul 2015	CLASS II	Minor Pack and Minor Pack II Pack recalled by Stradis Healthcare	Stradis Healthcare	Other	Nationwide
15 Jul 2015	CLASS II	Breast Pack - contains Devon Light Glove Used during surgery recalled	Stradis Healthcare	Other	Nationwide
15 Jul 2015	CLASS II	Basic Pack - contains Devon Light Glove Used during surgery recalled	Stradis Healthcare	Other	Nationwide
15 Jul 2015	CLASS II	Laser Evlt Pack and Laser One Leg Evlt recalled by Stradis Healthcare	Stradis Healthcare	Other	Nationwide
15 Jul 2015	CLASS II	ACL Pack - contains Devon Light Glove Used during surgery recalled	Stradis Healthcare	Other	Nationwide
15 Jul 2015	CLASS II	Face Lift Pack - contains Devon Light Glove Used during surgery recalled	Stradis Healthcare	Other	Nationwide
15 Jul 2015	CLASS II	Stradi 4500 - contains Devon Light Glove Used during surgery recalled	Stradis Healthcare	Other	Nationwide
15 Jul 2015	CLASS II	Breast Augmentation Pack and Breast Augmentation Expanded recalled	Stradis Healthcare	Other	Nationwide
15 Jul 2015	CLASS II	Gyn Pack - contains Devon Light Glove Used during surgery recalled	Stradis Healthcare	Other	Nationwide
15 Jul 2015	CLASS II	Set Up Pack - contains Devon Light Glove Used during surgery recalled	Stradis Healthcare	Other	Nationwide
15 Jul 2015	CLASS II	Bariatric Pack - contains Devon Light Glove Used during surgery recalled	Stradis Healthcare	Other	Nationwide
15 Jul 2015	CLASS II	Neurosurgery Pack - contains Devon Light Glove Used during surgery recalled	Stradis Healthcare	Other	Nationwide
15 Jul 2015	CLASS II	Orthopedic Split Drape Pack recalled by Stradis Healthcare	Stradis Healthcare	Other	Nationwide
15 Jul 2015	CLASS II	Eye Pack - contains Devon Light Glove Used during surgery recalled	Stradis Healthcare	Other	Nationwide
15 Jul 2015	CLASS II	Abdominal Pack and Abdom Pack recalled by Stradis Healthcare	Stradis Healthcare	Other	Nationwide

More recalls from Stradis Healthcare

All 71

Reported	Class	Recall	Company	Reason	Where
18 Jan 2023Device	CLASS II	Hct Central Line Insertion Tray, I recalled by Stradis Healthcare	Stradis Healthcare	Sterility	Nationwide
18 Jan 2023Device	CLASS II	HCT, 2 Port, Sterile, Triple Packaged, 10 EVA BAGS/Pack recalled	Stradis Healthcare	Sterility	Nationwide
18 Jan 2023Device	CLASS II	Tacy Medical, Inc Port Access Tray, Sterile, Qty recalled	Stradis Healthcare	Sterility	Nationwide
18 Jan 2023Device	CLASS II	Picc Kit, 10/cs, Access Medical Label recalled by Stradis Healthcare	Stradis Healthcare	Sterility	Nationwide
18 Jan 2023Device	CLASS II	Henry Shein Cysto Set UP Pack recalled by Stradis Healthcare	Stradis Healthcare	Sterility	Nationwide

Other Masks, Gloves & PPE recalls

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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