Device recall: Breast Pack - contains Devon Light Glove Used during surgery
FDA enforcement event 71130 is a device recall by Stradis Healthcare, LLC. of Lawrenceville, GA, initiated 20 Apr 2015 and classified Class II, with 51 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,153 device enforcement events initiated in 2015 carry the same class.
Status: Completed. Initiation: voluntary: firm initiated. This is the only enforcement event on this register for Stradis Healthcare, LLC..
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Stradis Healthcare, LLC., Lawrenceville, GA.
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."
Distribution
"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"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1992-2015 | Breast Pack - contains Devon Light Glove Used during surgery | 9 | Class II | Completed | 15 Jul 2015 |
| Z-1993-2015 | Basic Pack - contains Devon Light Glove Used during surgery | 6 | Class II | Completed | 15 Jul 2015 |
| Z-1994-2015 | Advanced Vein Care - contains Devon Light Glove Used during surgery | Two | Class II | Completed | 15 Jul 2015 |
| Z-1995-2015 | Vein Pack, Vein Treatment II Pack, Vein Brunswick Pack, Vein No Lidocaine Pack, Vein Ablation Pack - contains Devon Light Glove Used during surgery | 55 | Class II | Completed | 15 Jul 2015 |
| Z-1996-2015 | Endovenous Kit, Endo Pack and Endovenous Laser Kit - contains Devon Light Glove Used during surgery | 15 | Class II | Completed | 15 Jul 2015 |
| Z-1997-2015 | Phleb Pack and Laser Phleb Pack - contains Devon Light Glove Used during surgery | 9 | Class II | Completed | 15 Jul 2015 |
| Z-1998-2015 | Standard Pack - contains Devon Light Glove Used during surgery | One | Class II | Completed | 15 Jul 2015 |
| Z-1999-2015 | Lipo Pack, Liposuction Expended Pack, and Liposuction Tray - contains Devon Light Glove Used during surgery | 13 | Class II | Completed | 15 Jul 2015 |
| Z-2000-2015 | Lipo/Buttocks Pack - contains Devon Light Glove Used during surgery | One | Class II | Completed | 15 Jul 2015 |
| Z-2001-2015 | Vaginal Rejuvenation Pack - contains Devon Light Glove Used during surgery | One | Class II | Completed | 15 Jul 2015 |
| Z-2002-2015 | General Pack - contains Devon Light Glove Used during surgery | One | Class II | Completed | 15 Jul 2015 |
| Z-2003-2015 | Vein & Vascular Pack - contains Devon Light Glove Used during surgery | One | Class II | Completed | 15 Jul 2015 |
| Z-2004-2015 | Laser Evlt Pack and Laser One Leg Evlt - contains Devon Light Glove Used during surgery | 3 | Class II | Completed | 15 Jul 2015 |
| Z-2005-2015 | Breast Augmentation Pack and Breast Augmentation Expanded Pack - contains Devon Light Glove Used during surgery | 24 | Class II | Completed | 15 Jul 2015 |
| Z-2006-2015 | Tummy Tuck Pack - contains Devon Light Glove Used during surgery | One | Class II | Completed | 15 Jul 2015 |
| Z-2007-2015 | Surgical Pack and General Surgery Pack - contains Devon Light Glove Used during surgery | 4 | Class II | Completed | 15 Jul 2015 |
| Z-2008-2015 | Mississippi Pack - contains Devon Light Glove Used during surgery | One | Class II | Completed | 15 Jul 2015 |
| Z-2009-2015 | Face Lift Pack - contains Devon Light Glove Used during surgery | One | Class II | Completed | 15 Jul 2015 |
| Z-2010-2015 | Plastic Pack and Plastic HNP Pack - contains Devon Light Glove Used during surgery | 5 | Class II | Completed | 15 Jul 2015 |
| Z-2011-2015 | Suction Pack - contains Devon Light Glove Used during surgery | One | Class II | Completed | 15 Jul 2015 |
| Z-2012-2015 | ACL Pack - contains Devon Light Glove Used during surgery | One | Class II | Completed | 15 Jul 2015 |
| Z-2013-2015 | Hand Pack - contains Devon Light Glove Used during surgery | 3 | Class II | Completed | 15 Jul 2015 |
| Z-2014-2015 | Lima Pack - contains Devon Light Glove Used during surgery | 2 | Class II | Completed | 15 Jul 2015 |
| Z-2015-2015 | Skin and Vein Pack - contains Devon Light Glove Used during surgery | 3 | Class II | Completed | 15 Jul 2015 |
| Z-2016-2015 | Vasc Custom Kit - contains Devon Light Glove Used during surgery | 3 | Class II | Completed | 15 Jul 2015 |
| Z-2017-2015 | Bariatric Pack - contains Devon Light Glove Used during surgery | 1 | Class II | Completed | 15 Jul 2015 |
| Z-2018-2015 | Face Neck Pack - contains Devon Light Glove Used during surgery | 1 | Class II | Completed | 15 Jul 2015 |
| Z-2019-2015 | Abdominal Pack and Abdom Pack - contains Devon Light Glove Used during surgery | 2 | Class II | Completed | 15 Jul 2015 |
| Z-2020-2015 | Stradi 4500 - contains Devon Light Glove Used during surgery | 1 | Class II | Completed | 15 Jul 2015 |
| Z-2021-2015 | Gyn Pack - contains Devon Light Glove Used during surgery | 1 | Class II | Completed | 15 Jul 2015 |
| Z-2022-2015 | Head & Neck Pack - contains Devon Light Glove Used during surgery | 2 | Class II | Completed | 15 Jul 2015 |
| Z-2023-2015 | Eye Pack - contains Devon Light Glove Used during surgery | One | Class II | Completed | 15 Jul 2015 |
| Z-2024-2015 | Glaucoma Pack - contains Devon Light Glove Used during surgery | One | Class II | Completed | 15 Jul 2015 |
| Z-2025-2015 | Shoulder Pack - contains Devon Light Glove Used during surgery | One | Class II | Completed | 15 Jul 2015 |
| Z-2026-2015 | Knee Arthro Pack and Knee Arthro Pack II - contains Devon Light Glove Used during surgery | 3 | Class II | Completed | 15 Jul 2015 |
| Z-2027-2015 | ENT Pack - contains Devon Light Glove Used during surgery | 2 | Class II | Completed | 15 Jul 2015 |
| Z-2028-2015 | Hand Pack - contains Devon Light Glove Used during surgery | 4 | Class II | Completed | 15 Jul 2015 |
| Z-2029-2015 | Podiatry Pack - contains Devon Light Glove Used during surgery | 4 | Class II | Completed | 15 Jul 2015 |
| Z-2030-2015 | Minor Pack and Minor Pack II Pack - contains Devon Light Glove Used during surgery | 2 | Class II | Completed | 15 Jul 2015 |
| Z-2031-2015 | Neurosurgery Pack - contains Devon Light Glove Used during surgery | 1 | Class II | Completed | 15 Jul 2015 |
| Z-2032-2015 | Cysto Pack - contains Devon Light Glove Used during surgery | 1 | Class II | Completed | 15 Jul 2015 |
| Z-2033-2015 | Open Pack - contains Devon Light Glove Used during surgery | 1 | Class II | Completed | 15 Jul 2015 |
| Z-2034-2015 | Pediatric Pack - contains Devon Light Glove Used during surgery | 1 | Class II | Completed | 15 Jul 2015 |
| Z-2035-2015 | Face Lift Pack - contains Devon Light Glove Used during surgery | 1 | Class II | Completed | 15 Jul 2015 |
| Z-2036-2015 | Set Up Pack - contains Devon Light Glove Used during surgery | 1 | Class II | Completed | 15 Jul 2015 |
| Z-2037-2015 | Blepharoplasty Pack - contains Devon Light Glove Used during surgery | 1 | Class II | Completed | 15 Jul 2015 |
| Z-2038-2015 | Custom Pack - contains Devon Light Glove Used during surgery | 1 | Class II | Completed | 15 Jul 2015 |
| Z-2039-2015 | DND Pack - contains Devon Light Glove Used during surgery | 1 | Class II | Completed | 15 Jul 2015 |
| Z-2040-2015 | Orthopedic Split Drape Pack - contains Devon Light Glove Used during surgery | 1 | Class II | Completed | 15 Jul 2015 |
| Z-2041-2015 | Arthroscopy Pack - contains Devon Light Glove Used during surgery | 1 | Class II | Completed | 15 Jul 2015 |
| Z-2042-2015 | Upper Extremity Pack - contains Devon Light Glove Used during surgery | 1 | Class II | Completed | 15 Jul 2015 |
Context
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "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"
Is the recall still ongoing?
FDA lists the status as Completed. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.