🔍 RecallPedia

Covidien Devon Light Glove sub-assembly non-sterile For Kit Packers Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles

Class I - Dangerous
🏥 Medical Devices Recalled: September 29, 2016 Covidien Surgical Instruments Nationwide

What Should You Do?

  1. Check if you have this product:
    All lot codes in the following: Item Number Decription 56479 7335-SMC DELIVERY KIT 573208 7519-DHCG SURGI-START KIT 573210 7581-CSD SURGI-START KIT 573310 7417-SSC SURGI-START KIT 573326 7497-HLS MINI-PLUS KIT 573328 7437-NRF SURGI FOOTPACK ASCKIT 573343 7499-88 SURGICAL KIT 573346 7499-TLG SURGICAL KIT 573359 7499-HLW MINI-PLUS KIT 573368 7494-CAB2 SURGICAL KIT 573370 7411-SSI MINI PLUS KIT 573509 7696-GSL-VL SINGLE BASIN KIT 573529 7697-T4E SINGLE BASIN SURGI KI 573558 7665-CPB SINGLE BASIN KIT 573561 7696-KSC SINGLE BASIN KIT 573713 7553-SBT MINI-PLUS KIT 573732 7620-CWA SURGICAL ASC KIT 573741 7667-HMI SURGICAL ASC KIT 573776 7520-BHP SURGICAL ASC KITS 573777 7527-BHB SURGICAL ASC KITS 573798 7496-8KB MINI-PLUS KIT 573799 7516-UNIKB SET-UP KIT 573813 7590-GHF HAND AND FOOT PACK 773501 7692-WIW2 SURGI-START KIT 773701 7600-ESC SURGI-START KIT 31140208 3611 FLEXBL LITE GLOVE 1EA/PKG 31140216 3613 LITE GLV-FLEXIBLE 3EA/PKG 31140257 3612 LITE GLV-FLEXIBLE 2EA/PKG 31141479 K-1842-S STD. MINI-KIT STERILE 31141487 K-1560-S3 STD. MINI KIT STER. 31141495 K-1530-S3 STANDARD MINI-KIT 31141537 K-1940-S STD. MINI KIT STER. 31141552 K-1920-S STANDARD MINI-KIT 31141560 K-1200-S3 STD MINI-KIT 31141578 K-1840-S STD. MINI KIT STER. 31141586 K-1660-S STD. MINI-KIT STER. 31141602 K-1630-S STD. MINI KIT STER. 31141610 K-1615-S STD. MINI KIT STER. 31141628 K-1614-S STD MINI-KIT 31141651 K-1560-S STD. MINI KIT STERILE 31141669 K-1530-S STD. MINI KIT 31141677 K-1200-S STD. MINI KIT 31141784 K-1960-S STANDARD MINI-KIT 31141859 K-1615-S3 STD MINI-KIT 31141875 K-1940-S3 STD. MINI-KIT STER. 31144507 7519 BUNNY KIT - GENERAL BUNNY 31144879 7815 SURGI-START KIT STERILE 31144895 7614-T4 SURGI-START KIT 31144960 7693-T4 SURGI-START KIT 31144978 7766 SURGI-START KIT 31145025 7496-8 MINI-PLUS KIT - STERILE 31145215 7896 STANDARD SURGI-START KIT 31145231 7897 STD, SURGI-START KIT 31145249 7897-T8 SURGI-START KIT STER 31145298 7896-T8 STANDARD,SURGI START 31145363 7496-88 STANDARD,MINI-PLUS KIT 31145397 7497-8 STANDARD MINI PLUS KIT 31145413 7497-88 STANDARD,MINI-PLUS KIT 31145496 7696-T4 STANDARD SURGI-START 31145504 7708 STANDARD SURGI-START KIT 31145520 7614 SURGI-START KIT STERILE 31145546 7693 SURGI-START KIT STERILE 31145629 7696 STANDARD SURGI-START KIT 31145645 7608 SURGI START KIT STERILE 31149720 7496-NNB VAR. MINI PLUS KIT 31150470 7496-PUP VAR. MINI PLUS KIT 31152302 7896-NNB VAR. SURGI-START KIT 31153060 7697-T4 SURGI-START KIT 31153938 7756-KST VAR.SURGI-START KIT 31154266 7656-KST VAR. SURGI-START KIT 31175089 7497-8T6 STD MINI-KIT PLUS 31175105 7553-NAL VARIATION BUNNY KIT 31314720 7514-CCS VARIATION BUNNY KIT 31321097 7697 STD SURGI-START KIT 31324299 7830-HOH STD PLUS SURGI-START 31361234 7460-CNR2 MINI-PLUS KIT STD KT 31404851 BIRTHDAY KIT STANDARD PLUS 31451092 7600-DNV SURGI-START KIT STD 31451480 7493-SFW MINI-PLUS KIT STD 31453098 7682-MHP SURGI-START STD PLUS 31457131 7461-SMS MINI-PLUS KIT STD PLU 31460432 7596-SHH STD PLUS BUNNY KIT 50000148 K-1920-COE MINI-KT STAND-PLUS 50000510 7500-END STANDARD SURGICAL KIT 50000511 7516-UNI STANDARD SURGICAL KIT 50000512 7557-UNI UNIVERSAL SURGICAL KT 50000515 7667-BRT SURGI-START KIT STRD. 50000568 7605-SEC SURGI STANDARD PLUS K 50000599 7694-ADA SURGI-START KIT 50000947 7413-CAD MINI-PLUS KIT 50000980 7897-SME SURGI-START KIT 50001029 7417-PCP MINI-PLUS KIT 50001033 7520-FSF MINOR KIT 50001052 7427-CFS MINI-PLUS KIT 50001057 7484-HHS MINI-PLUS KIT 50007698 7698-T4 STANDARD SURGI-START K 50007699 7699-T4 STANDARD SURGI-STAR 50007898 7898-T8 STANDARD SURGI-START K 50007899 7899-T8 STANDARD SURGI-START K 50047403 7496-HCS MINI-PLUS KIT 50047405 7496-HES MINI-PLUS KIT 52000076E C-SECTION PACK 52000082E DELIVERY KIT 573375A MINI-PLUS KIT 573830D MINOR KIT 573831B MAJOR KIT
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Covidien LLC
Reason for Recall:
Added Instructions for Use: After application, inspect the Light Glove for barrier integrity
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Covidien Devon Light Glove sub-assembly non-sterile For Kit Packers Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles

Product Codes/Lot Numbers:

All lot codes in the following: Item Number Decription 56479 7335-SMC DELIVERY KIT 573208 7519-DHCG SURGI-START KIT 573210 7581-CSD SURGI-START KIT 573310 7417-SSC SURGI-START KIT 573326 7497-HLS MINI-PLUS KIT 573328 7437-NRF SURGI FOOTPACK ASCKIT 573343 7499-88 SURGICAL KIT 573346 7499-TLG SURGICAL KIT 573359 7499-HLW MINI-PLUS KIT 573368 7494-CAB2 SURGICAL KIT 573370 7411-SSI MINI PLUS KIT 573509 7696-GSL-VL SINGLE BASIN KIT 573529 7697-T4E SINGLE BASIN SURGI KI 573558 7665-CPB SINGLE BASIN KIT 573561 7696-KSC SINGLE BASIN KIT 573713 7553-SBT MINI-PLUS KIT 573732 7620-CWA SURGICAL ASC KIT 573741 7667-HMI SURGICAL ASC KIT 573776 7520-BHP SURGICAL ASC KITS 573777 7527-BHB SURGICAL ASC KITS 573798 7496-8KB MINI-PLUS KIT 573799 7516-UNIKB SET-UP KIT 573813 7590-GHF HAND AND FOOT PACK 773501 7692-WIW2 SURGI-START KIT 773701 7600-ESC SURGI-START KIT 31140208 3611 FLEXBL LITE GLOVE 1EA/PKG 31140216 3613 LITE GLV-FLEXIBLE 3EA/PKG 31140257 3612 LITE GLV-FLEXIBLE 2EA/PKG 31141479 K-1842-S STD. MINI-KIT STERILE 31141487 K-1560-S3 STD. MINI KIT STER. 31141495 K-1530-S3 STANDARD MINI-KIT 31141537 K-1940-S STD. MINI KIT STER. 31141552 K-1920-S STANDARD MINI-KIT 31141560 K-1200-S3 STD MINI-KIT 31141578 K-1840-S STD. MINI KIT STER. 31141586 K-1660-S STD. MINI-KIT STER. 31141602 K-1630-S STD. MINI KIT STER. 31141610 K-1615-S STD. MINI KIT STER. 31141628 K-1614-S STD MINI-KIT 31141651 K-1560-S STD. MINI KIT STERILE 31141669 K-1530-S STD. MINI KIT 31141677 K-1200-S STD. MINI KIT 31141784 K-1960-S STANDARD MINI-KIT 31141859 K-1615-S3 STD MINI-KIT 31141875 K-1940-S3 STD. MINI-KIT STER. 31144507 7519 BUNNY KIT - GENERAL BUNNY 31144879 7815 SURGI-START KIT STERILE 31144895 7614-T4 SURGI-START KIT 31144960 7693-T4 SURGI-START KIT 31144978 7766 SURGI-START KIT 31145025 7496-8 MINI-PLUS KIT - STERILE 31145215 7896 STANDARD SURGI-START KIT 31145231 7897 STD, SURGI-START KIT 31145249 7897-T8 SURGI-START KIT STER 31145298 7896-T8 STANDARD,SURGI START 31145363 7496-88 STANDARD,MINI-PLUS KIT 31145397 7497-8 STANDARD MINI PLUS KIT 31145413 7497-88 STANDARD,MINI-PLUS KIT 31145496 7696-T4 STANDARD SURGI-START 31145504 7708 STANDARD SURGI-START KIT 31145520 7614 SURGI-START KIT STERILE 31145546 7693 SURGI-START KIT STERILE 31145629 7696 STANDARD SURGI-START KIT 31145645 7608 SURGI START KIT STERILE 31149720 7496-NNB VAR. MINI PLUS KIT 31150470 7496-PUP VAR. MINI PLUS KIT 31152302 7896-NNB VAR. SURGI-START KIT 31153060 7697-T4 SURGI-START KIT 31153938 7756-KST VAR.SURGI-START KIT 31154266 7656-KST VAR. SURGI-START KIT 31175089 7497-8T6 STD MINI-KIT PLUS 31175105 7553-NAL VARIATION BUNNY KIT 31314720 7514-CCS VARIATION BUNNY KIT 31321097 7697 STD SURGI-START KIT 31324299 7830-HOH STD PLUS SURGI-START 31361234 7460-CNR2 MINI-PLUS KIT STD KT 31404851 BIRTHDAY KIT STANDARD PLUS 31451092 7600-DNV SURGI-START KIT STD 31451480 7493-SFW MINI-PLUS KIT STD 31453098 7682-MHP SURGI-START STD PLUS 31457131 7461-SMS MINI-PLUS KIT STD PLU 31460432 7596-SHH STD PLUS BUNNY KIT 50000148 K-1920-COE MINI-KT STAND-PLUS 50000510 7500-END STANDARD SURGICAL KIT 50000511 7516-UNI STANDARD SURGICAL KIT 50000512 7557-UNI UNIVERSAL SURGICAL KT 50000515 7667-BRT SURGI-START KIT STRD. 50000568 7605-SEC SURGI STANDARD PLUS K 50000599 7694-ADA SURGI-START KIT 50000947 7413-CAD MINI-PLUS KIT 50000980 7897-SME SURGI-START KIT 50001029 7417-PCP MINI-PLUS KIT 50001033 7520-FSF MINOR KIT 50001052 7427-CFS MINI-PLUS KIT 50001057 7484-HHS MINI-PLUS KIT 50007698 7698-T4 STANDARD SURGI-START K 50007699 7699-T4 STANDARD SURGI-STAR 50007898 7898-T8 STANDARD SURGI-START K 50007899 7899-T8 STANDARD SURGI-START K 50047403 7496-HCS MINI-PLUS KIT 50047405 7496-HES MINI-PLUS KIT 52000076E C-SECTION PACK 52000082E DELIVERY KIT 573375A MINI-PLUS KIT 573830D MINOR KIT 573831B MAJOR KIT

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0365-2017

Related Recalls

Covidien Nellcor Bedside SpO2 Patient Monitoring System: REF: PM100N, 10005941, DLPM100N, DL10005941, DSPM100N, 10005941-SG, DS10005941, 10005941J, 10005941JP, 10005941JPN

Covidien

Class I - Dangerous

Bedside SpO2 Patient Monitoring System alarms not heard/recognized, resulting in: treatment delay, lack of low oxygen saturation response, respiratory failure, arrhythmia. Highlighting operator's manual: 1)For patient Safety don't silence/decrease alarm volume, 2)Sensor off alarm (no perfusion detected) is low priority alarm, 3)Set monitors to Homecare Mode outside of hospital/professional setting

Jun 23, 2025 Diagnostic Equipment Nationwide View Details →