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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71130

51 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 20, 2015
Product types
Device
Classifications
Class II
Statuses
Completed
Recalling firm wording
Stradis Healthcare, LLC.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

51 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 51

Breast Pack - contains Devon Light Glove Used during surgery

Z-1992-2015
Recall number
Z-1992-2015
Initiated
April 20, 2015
Classification
Class II
Status
Completed
Recalling firm
Stradis Healthcare, LLC.
Quantity
9

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Pack 693-196, 693-188, 693-166, 693-112, 888-2583

Distribution pattern

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

device · product 2 of 51

Basic Pack - contains Devon Light Glove Used during surgery

Z-1993-2015
Recall number
Z-1993-2015
Initiated
April 20, 2015
Classification
Class II
Status
Completed
Recalling firm
Stradis Healthcare, LLC.
Quantity
6

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Pack 693-203, 888-2375, 888-2396, 888-2430, 888-2495, 888-2594

Distribution pattern

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

device · product 3 of 51

Advanced Vein Care - contains Devon Light Glove Used during surgery

Z-1994-2015
Recall number
Z-1994-2015
Initiated
April 20, 2015
Classification
Class II
Status
Completed
Recalling firm
Stradis Healthcare, LLC.
Quantity
Two

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Pack 682-956

Distribution pattern

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

device · product 4 of 51

Vein Pack, Vein Treatment II Pack, Vein Brunswick Pack, Vein No Lidocaine Pack, Vein Ablation Pack - contains Devon Light Glove Used during surgery

Z-1995-2015
Recall number
Z-1995-2015
Initiated
April 20, 2015
Classification
Class II
Status
Completed
Recalling firm
Stradis Healthcare, LLC.
Quantity
55

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Pack 682-949, 682-937, 682-900, 682-370, 682-218, 682-1264, 682-1529, 682-076, 682-192, 682-962, 682-968, 682-177, 682-394, 682-988, 682-156, 682-063, 682-151, 682-917, 682-250, 682-409, 682-960, 682-945, 682-218, 682-1264, 682-1412, 682-1422

Distribution pattern

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

device · product 5 of 51

Endovenous Kit, Endo Pack and Endovenous Laser Kit - contains Devon Light Glove Used during surgery

Z-1996-2015
Recall number
Z-1996-2015
Initiated
April 20, 2015
Classification
Class II
Status
Completed
Recalling firm
Stradis Healthcare, LLC.
Quantity
15

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Pack 682-156, 682-1548, 682-931, 682-493, 682-263, 682-931, 682-1419, 682-493, 682-044

Distribution pattern

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

device · product 6 of 51

Phleb Pack and Laser Phleb Pack - contains Devon Light Glove Used during surgery

Z-1997-2015
Recall number
Z-1997-2015
Initiated
April 20, 2015
Classification
Class II
Status
Completed
Recalling firm
Stradis Healthcare, LLC.
Quantity
9

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Pack 682-1284, 682-299, 682-410, 682-353, 682-377, 682-548

Distribution pattern

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

device · product 7 of 51

Standard Pack - contains Devon Light Glove Used during surgery

Z-1998-2015
Recall number
Z-1998-2015
Initiated
April 20, 2015
Classification
Class II
Status
Completed
Recalling firm
Stradis Healthcare, LLC.
Quantity
One

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Pack 681-022A

Distribution pattern

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

device · product 8 of 51

Lipo Pack, Liposuction Expended Pack, and Liposuction Tray - contains Devon Light Glove Used during surgery

Z-1999-2015
Recall number
Z-1999-2015
Initiated
April 20, 2015
Classification
Class II
Status
Completed
Recalling firm
Stradis Healthcare, LLC.
Quantity
13

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Pack 681-025, 681-268, 681-254, 681-013, 681-506, 888-2587

Distribution pattern

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

device · product 9 of 51

Lipo/Buttocks Pack - contains Devon Light Glove Used during surgery

Z-2000-2015
Recall number
Z-2000-2015
Initiated
April 20, 2015
Classification
Class II
Status
Completed
Recalling firm
Stradis Healthcare, LLC.
Quantity
One

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Pack 681-256

Distribution pattern

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

device · product 10 of 51

Vaginal Rejuvenation Pack - contains Devon Light Glove Used during surgery

Z-2001-2015
Recall number
Z-2001-2015
Initiated
April 20, 2015
Classification
Class II
Status
Completed
Recalling firm
Stradis Healthcare, LLC.
Quantity
One

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Pack 693-222

Distribution pattern

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

device · product 11 of 51

General Pack - contains Devon Light Glove Used during surgery

Z-2002-2015
Recall number
Z-2002-2015
Initiated
April 20, 2015
Classification
Class II
Status
Completed
Recalling firm
Stradis Healthcare, LLC.
Quantity
One

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Pack 670-115

Distribution pattern

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

device · product 12 of 51

Vein & Vascular Pack - contains Devon Light Glove Used during surgery

Z-2003-2015
Recall number
Z-2003-2015
Initiated
April 20, 2015
Classification
Class II
Status
Completed
Recalling firm
Stradis Healthcare, LLC.
Quantity
One

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Pack 682-670

Distribution pattern

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

device · product 13 of 51

Laser Evlt Pack and Laser One Leg Evlt - contains Devon Light Glove Used during surgery

Z-2004-2015
Recall number
Z-2004-2015
Initiated
April 20, 2015
Classification
Class II
Status
Completed
Recalling firm
Stradis Healthcare, LLC.
Quantity
3

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Pack 682-670, 682-501, 682-547

Distribution pattern

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

device · product 14 of 51

Breast Augmentation Pack and Breast Augmentation Expanded Pack - contains Devon Light Glove Used during surgery

Z-2005-2015
Recall number
Z-2005-2015
Initiated
April 20, 2015
Classification
Class II
Status
Completed
Recalling firm
Stradis Healthcare, LLC.
Quantity
24

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Pack 681-502, 693-177, 681-243, 681-502, 681-502, 693-158, 682-502, 681-503

Distribution pattern

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

device · product 15 of 51

Tummy Tuck Pack - contains Devon Light Glove Used during surgery

Z-2006-2015
Recall number
Z-2006-2015
Initiated
April 20, 2015
Classification
Class II
Status
Completed
Recalling firm
Stradis Healthcare, LLC.
Quantity
One

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Pack 693-223

Distribution pattern

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

device · product 16 of 51

Surgical Pack and General Surgery Pack - contains Devon Light Glove Used during surgery

Z-2007-2015
Recall number
Z-2007-2015
Initiated
April 20, 2015
Classification
Class II
Status
Completed
Recalling firm
Stradis Healthcare, LLC.
Quantity
4

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Pack 40604EBS, 693-152, 40759MMS, 888-2371

Distribution pattern

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

device · product 17 of 51

Mississippi Pack - contains Devon Light Glove Used during surgery

Z-2008-2015
Recall number
Z-2008-2015
Initiated
April 20, 2015
Classification
Class II
Status
Completed
Recalling firm
Stradis Healthcare, LLC.
Quantity
One

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Pack 682-1302

Distribution pattern

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

device · product 18 of 51

Face Lift Pack - contains Devon Light Glove Used during surgery

Z-2009-2015
Recall number
Z-2009-2015
Initiated
April 20, 2015
Classification
Class II
Status
Completed
Recalling firm
Stradis Healthcare, LLC.
Quantity
One

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Pack 693-102

Distribution pattern

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

device · product 19 of 51

Plastic Pack and Plastic HNP Pack - contains Devon Light Glove Used during surgery

Z-2010-2015
Recall number
Z-2010-2015
Initiated
April 20, 2015
Classification
Class II
Status
Completed
Recalling firm
Stradis Healthcare, LLC.
Quantity
5

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Pack 693-210, 693-054, 693-219, 888-2479, 888-2499

Distribution pattern

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

device · product 20 of 51

Suction Pack - contains Devon Light Glove Used during surgery

Z-2011-2015
Recall number
Z-2011-2015
Initiated
April 20, 2015
Classification
Class II
Status
Completed
Recalling firm
Stradis Healthcare, LLC.
Quantity
One

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Pack 670-057

Distribution pattern

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

device · product 21 of 51

ACL Pack - contains Devon Light Glove Used during surgery

Z-2012-2015
Recall number
Z-2012-2015
Initiated
April 20, 2015
Classification
Class II
Status
Completed
Recalling firm
Stradis Healthcare, LLC.
Quantity
One

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Pack 693-055

Distribution pattern

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

device · product 22 of 51

Hand Pack - contains Devon Light Glove Used during surgery

Z-2013-2015
Recall number
Z-2013-2015
Initiated
April 20, 2015
Classification
Class II
Status
Completed
Recalling firm
Stradis Healthcare, LLC.
Quantity
3

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Pack 693-057, 888-2345, 888-2596

Distribution pattern

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

device · product 23 of 51

Lima Pack - contains Devon Light Glove Used during surgery

Z-2014-2015
Recall number
Z-2014-2015
Initiated
April 20, 2015
Classification
Class II
Status
Completed
Recalling firm
Stradis Healthcare, LLC.
Quantity
2

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Pack 682-927

Distribution pattern

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

device · product 24 of 51

Skin and Vein Pack - contains Devon Light Glove Used during surgery

Z-2015-2015
Recall number
Z-2015-2015
Initiated
April 20, 2015
Classification
Class II
Status
Completed
Recalling firm
Stradis Healthcare, LLC.
Quantity
3

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Pack 682-1218

Distribution pattern

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

device · product 25 of 51

Vasc Custom Kit - contains Devon Light Glove Used during surgery

Z-2016-2015
Recall number
Z-2016-2015
Initiated
April 20, 2015
Classification
Class II
Status
Completed
Recalling firm
Stradis Healthcare, LLC.
Quantity
3

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Pack 682-126

Distribution pattern

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

device · product 26 of 51

Bariatric Pack - contains Devon Light Glove Used during surgery

Z-2017-2015
Recall number
Z-2017-2015
Initiated
April 20, 2015
Classification
Class II
Status
Completed
Recalling firm
Stradis Healthcare, LLC.
Quantity
1

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Pack 682-678

Distribution pattern

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

device · product 27 of 51

Face Neck Pack - contains Devon Light Glove Used during surgery

Z-2018-2015
Recall number
Z-2018-2015
Initiated
April 20, 2015
Classification
Class II
Status
Completed
Recalling firm
Stradis Healthcare, LLC.
Quantity
1

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Pack 693-167

Distribution pattern

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

device · product 28 of 51

Abdominal Pack and Abdom Pack - contains Devon Light Glove Used during surgery

Z-2019-2015
Recall number
Z-2019-2015
Initiated
April 20, 2015
Classification
Class II
Status
Completed
Recalling firm
Stradis Healthcare, LLC.
Quantity
2

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Pack 670-056, 681-014

Distribution pattern

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

device · product 29 of 51

Stradi 4500 - contains Devon Light Glove Used during surgery

Z-2020-2015
Recall number
Z-2020-2015
Initiated
April 20, 2015
Classification
Class II
Status
Completed
Recalling firm
Stradis Healthcare, LLC.
Quantity
1

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Pack 682-1102

Distribution pattern

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

device · product 30 of 51

Gyn Pack - contains Devon Light Glove Used during surgery

Z-2021-2015
Recall number
Z-2021-2015
Initiated
April 20, 2015
Classification
Class II
Status
Completed
Recalling firm
Stradis Healthcare, LLC.
Quantity
1

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Pack 693-111

Distribution pattern

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

device · product 31 of 51

Head & Neck Pack - contains Devon Light Glove Used during surgery

Z-2022-2015
Recall number
Z-2022-2015
Initiated
April 20, 2015
Classification
Class II
Status
Completed
Recalling firm
Stradis Healthcare, LLC.
Quantity
2

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Pack 681-012, 888-2385

Distribution pattern

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

device · product 32 of 51

Eye Pack - contains Devon Light Glove Used during surgery

Z-2023-2015
Recall number
Z-2023-2015
Initiated
April 20, 2015
Classification
Class II
Status
Completed
Recalling firm
Stradis Healthcare, LLC.
Quantity
One

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Pack 687-191

Distribution pattern

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

device · product 33 of 51

Glaucoma Pack - contains Devon Light Glove Used during surgery

Z-2024-2015
Recall number
Z-2024-2015
Initiated
April 20, 2015
Classification
Class II
Status
Completed
Recalling firm
Stradis Healthcare, LLC.
Quantity
One

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Pack 687-395

Distribution pattern

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

device · product 34 of 51

Shoulder Pack - contains Devon Light Glove Used during surgery

Z-2025-2015
Recall number
Z-2025-2015
Initiated
April 20, 2015
Classification
Class II
Status
Completed
Recalling firm
Stradis Healthcare, LLC.
Quantity
One

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Pack 888-2349

Distribution pattern

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

device · product 35 of 51

Knee Arthro Pack and Knee Arthro Pack II - contains Devon Light Glove Used during surgery

Z-2026-2015
Recall number
Z-2026-2015
Initiated
April 20, 2015
Classification
Class II
Status
Completed
Recalling firm
Stradis Healthcare, LLC.
Quantity
3

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Pack 888-2359, 888-2531, 888-2351

Distribution pattern

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

device · product 36 of 51

ENT Pack - contains Devon Light Glove Used during surgery

Z-2027-2015
Recall number
Z-2027-2015
Initiated
April 20, 2015
Classification
Class II
Status
Completed
Recalling firm
Stradis Healthcare, LLC.
Quantity
2

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Pack 888-2352, 888-2434

Distribution pattern

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

device · product 37 of 51

Hand Pack - contains Devon Light Glove Used during surgery

Z-2028-2015
Recall number
Z-2028-2015
Initiated
April 20, 2015
Classification
Class II
Status
Completed
Recalling firm
Stradis Healthcare, LLC.
Quantity
4

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Pack 888-2376, 888-2397, 888-2414, 888-2471

Distribution pattern

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

device · product 38 of 51

Podiatry Pack - contains Devon Light Glove Used during surgery

Z-2029-2015
Recall number
Z-2029-2015
Initiated
April 20, 2015
Classification
Class II
Status
Completed
Recalling firm
Stradis Healthcare, LLC.
Quantity
4

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Pack 888-2378, 888-2411, 888-2429, 888-2553

Distribution pattern

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

device · product 39 of 51

Minor Pack and Minor Pack II Pack - contains Devon Light Glove Used during surgery

Z-2030-2015
Recall number
Z-2030-2015
Initiated
April 20, 2015
Classification
Class II
Status
Completed
Recalling firm
Stradis Healthcare, LLC.
Quantity
2

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Pack 888-2381, 888-2541

Distribution pattern

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

device · product 40 of 51

Neurosurgery Pack - contains Devon Light Glove Used during surgery

Z-2031-2015
Recall number
Z-2031-2015
Initiated
April 20, 2015
Classification
Class II
Status
Completed
Recalling firm
Stradis Healthcare, LLC.
Quantity
1

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Pack 888-2489

Distribution pattern

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

device · product 41 of 51

Cysto Pack - contains Devon Light Glove Used during surgery

Z-2032-2015
Recall number
Z-2032-2015
Initiated
April 20, 2015
Classification
Class II
Status
Completed
Recalling firm
Stradis Healthcare, LLC.
Quantity
1

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Pack 888-2492

Distribution pattern

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

device · product 42 of 51

Open Pack - contains Devon Light Glove Used during surgery

Z-2033-2015
Recall number
Z-2033-2015
Initiated
April 20, 2015
Classification
Class II
Status
Completed
Recalling firm
Stradis Healthcare, LLC.
Quantity
1

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Pack 888-2493

Distribution pattern

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

device · product 43 of 51

Pediatric Pack - contains Devon Light Glove Used during surgery

Z-2034-2015
Recall number
Z-2034-2015
Initiated
April 20, 2015
Classification
Class II
Status
Completed
Recalling firm
Stradis Healthcare, LLC.
Quantity
1

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Pack 888-2494

Distribution pattern

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

device · product 44 of 51

Face Lift Pack - contains Devon Light Glove Used during surgery

Z-2035-2015
Recall number
Z-2035-2015
Initiated
April 20, 2015
Classification
Class II
Status
Completed
Recalling firm
Stradis Healthcare, LLC.
Quantity
1

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Pack 888-2532

Distribution pattern

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

device · product 45 of 51

Set Up Pack - contains Devon Light Glove Used during surgery

Z-2036-2015
Recall number
Z-2036-2015
Initiated
April 20, 2015
Classification
Class II
Status
Completed
Recalling firm
Stradis Healthcare, LLC.
Quantity
1

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Pack 888-2546

Distribution pattern

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

device · product 46 of 51

Blepharoplasty Pack - contains Devon Light Glove Used during surgery

Z-2037-2015
Recall number
Z-2037-2015
Initiated
April 20, 2015
Classification
Class II
Status
Completed
Recalling firm
Stradis Healthcare, LLC.
Quantity
1

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Pack 888-2533

Distribution pattern

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

device · product 47 of 51

Custom Pack - contains Devon Light Glove Used during surgery

Z-2038-2015
Recall number
Z-2038-2015
Initiated
April 20, 2015
Classification
Class II
Status
Completed
Recalling firm
Stradis Healthcare, LLC.
Quantity
1

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Pack 888-2552

Distribution pattern

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

device · product 48 of 51

DND Pack - contains Devon Light Glove Used during surgery

Z-2039-2015
Recall number
Z-2039-2015
Initiated
April 20, 2015
Classification
Class II
Status
Completed
Recalling firm
Stradis Healthcare, LLC.
Quantity
1

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Pack 888-2595

Distribution pattern

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

device · product 49 of 51

Orthopedic Split Drape Pack - contains Devon Light Glove Used during surgery

Z-2040-2015
Recall number
Z-2040-2015
Initiated
April 20, 2015
Classification
Class II
Status
Completed
Recalling firm
Stradis Healthcare, LLC.
Quantity
1

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Pack 888-2604

Distribution pattern

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

device · product 50 of 51

Arthroscopy Pack - contains Devon Light Glove Used during surgery

Z-2041-2015
Recall number
Z-2041-2015
Initiated
April 20, 2015
Classification
Class II
Status
Completed
Recalling firm
Stradis Healthcare, LLC.
Quantity
1

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Pack 888-2605

Distribution pattern

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

device · product 51 of 51

Upper Extremity Pack - contains Devon Light Glove Used during surgery

Z-2042-2015
Recall number
Z-2042-2015
Initiated
April 20, 2015
Classification
Class II
Status
Completed
Recalling firm
Stradis Healthcare, LLC.
Quantity
1

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Pack 888-2606

Distribution pattern

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