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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71113

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

Open FDA event record

Event summary

Timeline bucket
April 16, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Covidien 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

14 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 14

Covidien Devon Light Gloves, Sterile-Single Units A disposable, sterile, single-use cover for compatible surgical light handles. Catalog/Number/Description 31140208 3611 LIGHT GLOVE 31140216 3613 LIGHT GLOVE 31140257 3612 LIGHT GLOVE

Z-2106-2015
Recall number
Z-2106-2015
Initiated
April 16, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
26,108,946 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devon Light Gloves contain splits or holes compromising the sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devon Light Gloves contain splits or holes compromising the sterility

Code information

Lot number begins 508xxxx or lower

Distribution pattern

Worldwide Distribution-US (nationwide) including the Virgin Islands and the countries of Canada, Australia, New Zealand, Costa Rica, Austria, Belgium, Bulgaria, Czech Republic, Denmark, Finland , France, Germany, Netherlands, Sweden, Ireland, ISRAEL,Spain, Italy, Jordan, Kenya, Kuwait, United Kingdom, Lebanon, Liechtenstein, Luxembourg, Monaco, South Africa, Norway, Poland, Portugal, Qatar, Russia, Saudi Arabia, Slovenia, Switzerland, Turkey, and UAE.

device · product 2 of 14

Delivery/C-Section, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 56479 7335-SMC C-Section Kit 31404851 7382-OTO2 Delivery Kit 52000076E 7339-ES C-SECTION DELUXE PACK 52000082E 7335-HUV DELIVERY KIT

Z-2107-2015
Recall number
Z-2107-2015
Initiated
April 16, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
8,630 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devon Light Gloves contain splits or holes compromising the sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devon Light Gloves contain splits or holes compromising the sterility

Code information

Lot number begins 508xxxx or lower

Distribution pattern

Worldwide Distribution-US (nationwide) including the Virgin Islands and the countries of Canada, Australia, New Zealand, Costa Rica, Austria, Belgium, Bulgaria, Czech Republic, Denmark, Finland , France, Germany, Netherlands, Sweden, Ireland, ISRAEL,Spain, Italy, Jordan, Kenya, Kuwait, United Kingdom, Lebanon, Liechtenstein, Luxembourg, Monaco, South Africa, Norway, Poland, Portugal, Qatar, Russia, Saudi Arabia, Slovenia, Switzerland, Turkey, and UAE.

device · product 3 of 14

Mini-Kits, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description 31141479 K-1842-S OR Mini Kit 31141487 K-1560-S3 OR Mini Kit 31141495 K-1530-S3 OR Mini Kit 31141537 K-1940-S OR Mini Kit 31141552 K-1920-S OR Mini Kit 31141560 K-1200-S3 OR Mini Kit 31141578 K-1840-S OR Mini Kit 31141586 K-1660-S OR Mini Kit 31141602 K-1630-S OR Mini Kit 31141610 K-1615-S OR Mini Kit 31141628 K-1614-S OR Mini Kit 31141651 K-1560-S OR Mini Kit 31141669 K-1530-S OR Mini Kit 31141677 K-1200-S OR Mini Kit 31141784 K-1960-S OR Mini Kit 31141859 K-1615-S3 OR Mini Kit 31141875 K-1940-S3 OR Mini Kit 31145025 7496-8 MINI-PLUS KIT 31145397 7497-8 MINI-PLUS KIT 31145413 7497-88 Mini-Plus Kit 31150470 7496-PUP MINI PLUS KIT 50000148 K-1920-COE MINI-KIT 50047403 7496-HCS MINI-PLUS KIT 50047405 7496-HES MINI-PLUS KIT 573375A MINI-PLUS KIT

Z-2108-2015
Recall number
Z-2108-2015
Initiated
April 16, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
559,108 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devon Light Gloves contain splits or holes compromising the sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devon Light Gloves contain splits or holes compromising the sterility

Code information

Lot number begins 508xxxx or lower

Distribution pattern

Worldwide Distribution-US (nationwide) including the Virgin Islands and the countries of Canada, Australia, New Zealand, Costa Rica, Austria, Belgium, Bulgaria, Czech Republic, Denmark, Finland , France, Germany, Netherlands, Sweden, Ireland, ISRAEL,Spain, Italy, Jordan, Kenya, Kuwait, United Kingdom, Lebanon, Liechtenstein, Luxembourg, Monaco, South Africa, Norway, Poland, Portugal, Qatar, Russia, Saudi Arabia, Slovenia, Switzerland, Turkey, and UAE.

device · product 4 of 14

Minor Surgical Kits, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 573208 7519-DHCG MINOR KIT 573210 7581-CSD Minor KIT 573741 7667-HMI Minor Kit 31144507 7519 Minor Surgical Kit 573830D MINOR KIT

Z-2109-2015
Recall number
Z-2109-2015
Initiated
April 16, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
81,252 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devon Light Gloves contain splits or holes compromising the sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devon Light Gloves contain splits or holes compromising the sterility

Code information

Lot number begins 508xxxx or lower

Distribution pattern

Worldwide Distribution-US (nationwide) including the Virgin Islands and the countries of Canada, Australia, New Zealand, Costa Rica, Austria, Belgium, Bulgaria, Czech Republic, Denmark, Finland , France, Germany, Netherlands, Sweden, Ireland, ISRAEL,Spain, Italy, Jordan, Kenya, Kuwait, United Kingdom, Lebanon, Liechtenstein, Luxembourg, Monaco, South Africa, Norway, Poland, Portugal, Qatar, Russia, Saudi Arabia, Slovenia, Switzerland, Turkey, and UAE.

device · product 5 of 14

Surgical Set Up kit, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 31144895 7614-T4 Single Basin Set Up Kit 31144960 7693-T4 Single Basin Set Up Kit 31144978 7766 Double Basin Set Up Kit 31145215 7896 Double Basin Set Up Kit 31145231 7897 Double Basin Set Up Kit 31145249 7897-T8 Double Basin Set Up Kit 31145298 7896-T8 Double Basin Set Up Kit 31145496 7696-T4 Single Basin Set Up Kit 31145520 7614 Single Basin Set Up Kit 31145546 7693 Single Basin Set Up Kit 31145629 7696 Single Basin Set Up Kit 31153938 7756-KST Surgical Set Up Kit 31154266 7656-KST Surgical Set Up Kit 31321097 7697 Surgical Set Up Kit 31324299 7830-HOH Surgical Set Up Kit 31451092 7600-DNV Surgical Set Up Kit 31453098 7682-MHP Surgical Set Up Kit

Z-2110-2015
Recall number
Z-2110-2015
Initiated
April 16, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
33,256 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devon Light Gloves contain splits or holes compromising the sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devon Light Gloves contain splits or holes compromising the sterility

Code information

Lot number begins 508xxxx or lower

Distribution pattern

Worldwide Distribution-US (nationwide) including the Virgin Islands and the countries of Canada, Australia, New Zealand, Costa Rica, Austria, Belgium, Bulgaria, Czech Republic, Denmark, Finland , France, Germany, Netherlands, Sweden, Ireland, ISRAEL,Spain, Italy, Jordan, Kenya, Kuwait, United Kingdom, Lebanon, Liechtenstein, Luxembourg, Monaco, South Africa, Norway, Poland, Portugal, Qatar, Russia, Saudi Arabia, Slovenia, Switzerland, Turkey, and UAE.

device · product 6 of 14

ASC (Breast) Kit, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Decription: 573328 7437-NRF SURGICAL ASC KIT 50000511 7516-UNI Universal ASC Kit 50000512 7557-UNI Universal ASC Kit 50000515 7667-BRT Breast ASC Kit

Z-2111-2015
Recall number
Z-2111-2015
Initiated
April 16, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
4,136 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devon Light Gloves contain splits or holes compromising the sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devon Light Gloves contain splits or holes compromising the sterility

Code information

Lot number begins 508xxxx or lower

Distribution pattern

Worldwide Distribution-US (nationwide) including the Virgin Islands and the countries of Canada, Australia, New Zealand, Costa Rica, Austria, Belgium, Bulgaria, Czech Republic, Denmark, Finland , France, Germany, Netherlands, Sweden, Ireland, ISRAEL,Spain, Italy, Jordan, Kenya, Kuwait, United Kingdom, Lebanon, Liechtenstein, Luxembourg, Monaco, South Africa, Norway, Poland, Portugal, Qatar, Russia, Saudi Arabia, Slovenia, Switzerland, Turkey, and UAE.

device · product 7 of 14

Surgical Kit Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 573326 7497-HLS Surgical Kit 573328 7437-NRF SURGICAL ASC KIT 573343 7499-88 SURGICAL KIT with Light Gloves 573346 7499-TLG Surgical Kit with Edge 573359 7499-HLW Surgical KIT 573368 7494-CAB2 SURGICAL KIT 573776 7520-BHP SURGICAL KIT 573777 7527-BHB SURGICAL KITS 573798 7496-8KB Surgical KIT 31144507 7519 Minor Surgical Kit 31175089 7497-8T6 Surgical Kit 31321097 7697 Surgical Set Up Kit 31451480 7493-SFW SURGICAL KIT 31460432 7596-SHH Surgical KIT 50000947 7413-CAD Surgical KIT 50001029 7417-PCP Surgical KIT 50001052 7427-CFS Surgical KIT

Z-2112-2015
Recall number
Z-2112-2015
Initiated
April 16, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
114,813 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devon Light Gloves contain splits or holes compromising the sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devon Light Gloves contain splits or holes compromising the sterility

Code information

Lot number begins 508xxxx or lower

Distribution pattern

Worldwide Distribution-US (nationwide) including the Virgin Islands and the countries of Canada, Australia, New Zealand, Costa Rica, Austria, Belgium, Bulgaria, Czech Republic, Denmark, Finland , France, Germany, Netherlands, Sweden, Ireland, ISRAEL,Spain, Italy, Jordan, Kenya, Kuwait, United Kingdom, Lebanon, Liechtenstein, Luxembourg, Monaco, South Africa, Norway, Poland, Portugal, Qatar, Russia, Saudi Arabia, Slovenia, Switzerland, Turkey, and UAE.

device · product 8 of 14

Double Basin Kit ,Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 31145504 7708 Double Basin Kit 50007898 7898-T8 Double Basin Kit 50007899 7899-T8 Double Basin Kit

Z-2113-2015
Recall number
Z-2113-2015
Initiated
April 16, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
5,786 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devon Light Gloves contain splits or holes compromising the sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devon Light Gloves contain splits or holes compromising the sterility

Code information

Lot number begins 508xxxx or lower

Distribution pattern

Worldwide Distribution-US (nationwide) including the Virgin Islands and the countries of Canada, Australia, New Zealand, Costa Rica, Austria, Belgium, Bulgaria, Czech Republic, Denmark, Finland , France, Germany, Netherlands, Sweden, Ireland, ISRAEL,Spain, Italy, Jordan, Kenya, Kuwait, United Kingdom, Lebanon, Liechtenstein, Luxembourg, Monaco, South Africa, Norway, Poland, Portugal, Qatar, Russia, Saudi Arabia, Slovenia, Switzerland, Turkey, and UAE.

device · product 9 of 14

Major Kit, Sterile-.Kits containing the Devon Light Glove Catalog Number:Description 573831B MAJOR KIT

Z-2114-2015
Recall number
Z-2114-2015
Initiated
April 16, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
5,160 kit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devon Light Gloves contain splits or holes compromising the sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devon Light Gloves contain splits or holes compromising the sterility

Code information

Lot number begins 508xxxx or lower

Distribution pattern

Worldwide Distribution-US (nationwide) including the Virgin Islands and the countries of Canada, Australia, New Zealand, Costa Rica, Austria, Belgium, Bulgaria, Czech Republic, Denmark, Finland , France, Germany, Netherlands, Sweden, Ireland, ISRAEL,Spain, Italy, Jordan, Kenya, Kuwait, United Kingdom, Lebanon, Liechtenstein, Luxembourg, Monaco, South Africa, Norway, Poland, Portugal, Qatar, Russia, Saudi Arabia, Slovenia, Switzerland, Turkey, and UAE.

device · product 10 of 14

Single Basin Kits, Sterile-.Kits containing the Devon Light Glove Catalog Number/Description: 573509 7696-GSL-VL SINGLE BASIN KIT 573558 7665-CPB SINGLE BASIN KIT 573561 7696-KSC SINGLE BASIN KIT 31145645 7608 Single Basin KIT 31153060 7697-T4 Single Basin Kit 50000568 7605-SEC Single Basin Kit 50000599 7694-ADA Single Basin Kit 50007698 7698-T4 Single Basin Kit 50007699 7699-T4 Single Basin Kit

Z-2115-2015
Recall number
Z-2115-2015
Initiated
April 16, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
77,588 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devon Light Gloves contain splits or holes compromising the sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devon Light Gloves contain splits or holes compromising the sterility

Code information

Lot number begins 508xxxx or lower

Distribution pattern

Worldwide Distribution-US (nationwide) including the Virgin Islands and the countries of Canada, Australia, New Zealand, Costa Rica, Austria, Belgium, Bulgaria, Czech Republic, Denmark, Finland , France, Germany, Netherlands, Sweden, Ireland, ISRAEL,Spain, Italy, Jordan, Kenya, Kuwait, United Kingdom, Lebanon, Liechtenstein, Luxembourg, Monaco, South Africa, Norway, Poland, Portugal, Qatar, Russia, Saudi Arabia, Slovenia, Switzerland, Turkey, and UAE.

device · product 11 of 14

Augmentation Kit , Sterile-.Kits containing the Devon Light Glove Catalog Number/Description 573732 7620-CWA Augmentation Kit

Z-2116-2015
Recall number
Z-2116-2015
Initiated
April 16, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
144 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devon Light Gloves contain splits or holes compromising the sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devon Light Gloves contain splits or holes compromising the sterility

Code information

Lot number begins 508xxxx or lower

Distribution pattern

Worldwide Distribution-US (nationwide) including the Virgin Islands and the countries of Canada, Australia, New Zealand, Costa Rica, Austria, Belgium, Bulgaria, Czech Republic, Denmark, Finland , France, Germany, Netherlands, Sweden, Ireland, ISRAEL,Spain, Italy, Jordan, Kenya, Kuwait, United Kingdom, Lebanon, Liechtenstein, Luxembourg, Monaco, South Africa, Norway, Poland, Portugal, Qatar, Russia, Saudi Arabia, Slovenia, Switzerland, Turkey, and UAE.

device · product 12 of 14

NS-3600-B LITE GLOVE 1000/CASE -Bulk, Non-sterile Catalog Number: 571711

Z-2117-2015
Recall number
Z-2117-2015
Initiated
April 16, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devon Light Gloves contain splits or holes compromising the sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devon Light Gloves contain splits or holes compromising the sterility

Code information

Lot number begins 508xxxx or lower

Distribution pattern

Worldwide Distribution-US (nationwide) including the Virgin Islands and the countries of Canada, Australia, New Zealand, Costa Rica, Austria, Belgium, Bulgaria, Czech Republic, Denmark, Finland , France, Germany, Netherlands, Sweden, Ireland, ISRAEL,Spain, Italy, Jordan, Kenya, Kuwait, United Kingdom, Lebanon, Liechtenstein, Luxembourg, Monaco, South Africa, Norway, Poland, Portugal, Qatar, Russia, Saudi Arabia, Slovenia, Switzerland, Turkey, and UAE.

device · product 13 of 14

Non Sterile Subassembly: Catalog Number/Description: SA1008 NONSTERILE SUBASSEMBLY SA1578 NO-STERILE SUBASSEMBLY SA2000 NON STERILE SUBASSEMBLY SA2001 NON STERILE SUBASSEMBLY SA2002 NON STERILE SUBASSEMBLY SA2004 NON STERILE SUBASSEMBLY SA2005 NON STERILE SUBASSEMBLY SA2006 NON STERILE SUBASSEMBLY SA2007 NON STERILE SUBASSEMBLY SA2008 SA-7457-R NS SUBASSEMBLY SA2032B NSSA SA2038A NSSA SA2042 SA2042 SUBASSEMBLY NS SA2049 SA2049 NON STERILE SUBASSEMBLY SA2058B NSSA SA2074 SA2074 NON STERILE SUBASSEMBLY SA2075 SA2075 NON STERILE SUBASSEMBLY SA2109 SA2109 NON STERILE SUBASSY SA2119 SA2119 NON STERILE SUBASSY SA2120 SA2120 NON STERILE SUBASSY SA2121 NON STERILE SUBASSY SA2122 SA2122 NON STERILE SUBASSY SA2164A NSSA SA2172A NSSA SA2172B NSSA SA2173C NSSA SA2174B NSSA SA2185 SRM800 NSSA SA2198D NSSA SA2199 SA2199 NON STERILE SUBASSY SA2219 NSSA SA3011 SA3011 NON STERILE SUBASSY SA3013 SA3013 NON STERILE SUBASSY SA3018 SA3018 NON STERILE SUBASSY SA3040 SA3040 NON STERILE SUBASSY SA3045 NSSA SA3060 SA3060 NON STERILE SUBASSY SA3062A NSSA SUBASSEMBLY SA3068 SA3068 NON STERILE SUBASSY SA3069 SA3069 NON STERILE SUBASSY SA3071 SA3071 NON STERILE SUBASSY SA3076 NSSA SA3076A NSSA SA3077 NSSA BUTTON SA3078 NSSA ROCKER SA3080 NSSA SA4003 NON STERILE SUBASSEMBLY SA4003A NON STERILE SUBASSEMBLY SA4013 NSSA SA4014 NSSA SA4015 NSSA SA5006 NSSA SA5015 NSSA SA5017 NON STERILE SUBASSEMBLY SA2140 SA2140 NON STERILE SUBASSY

Z-2118-2015
Recall number
Z-2118-2015
Initiated
April 16, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
385486

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devon Light Gloves contain splits or holes compromising the sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devon Light Gloves contain splits or holes compromising the sterility

Code information

Lot number begins 508xxxx or lower

Distribution pattern

Worldwide Distribution-US (nationwide) including the Virgin Islands and the countries of Canada, Australia, New Zealand, Costa Rica, Austria, Belgium, Bulgaria, Czech Republic, Denmark, Finland , France, Germany, Netherlands, Sweden, Ireland, ISRAEL,Spain, Italy, Jordan, Kenya, Kuwait, United Kingdom, Lebanon, Liechtenstein, Luxembourg, Monaco, South Africa, Norway, Poland, Portugal, Qatar, Russia, Saudi Arabia, Slovenia, Switzerland, Turkey, and UAE.

device · product 14 of 14

Hysto Pack, Non-sterile Part Number Description SA2059B MAJOR BASIN SA2220 HYSTO PACK SA2220A HYSTO PACK

Z-2119-2015
Recall number
Z-2119-2015
Initiated
April 16, 2015
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
23560

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devon Light Gloves contain splits or holes compromising the sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devon Light Gloves contain splits or holes compromising the sterility

Code information

Lot number begins 508xxxx or lower

Distribution pattern

Worldwide Distribution-US (nationwide) including the Virgin Islands and the countries of Canada, Australia, New Zealand, Costa Rica, Austria, Belgium, Bulgaria, Czech Republic, Denmark, Finland , France, Germany, Netherlands, Sweden, Ireland, ISRAEL,Spain, Italy, Jordan, Kenya, Kuwait, United Kingdom, Lebanon, Liechtenstein, Luxembourg, Monaco, South Africa, Norway, Poland, Portugal, Qatar, Russia, Saudi Arabia, Slovenia, Switzerland, Turkey, and UAE.