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

Class I - Dangerous

🏥 Medical Devices Recalled: June 23, 2025 Covidien Diagnostic Equipment Nationwide

What Should You Do?

Check if you have this product:
REF/UI-DI/Bundle Code/IFU Part Number: PM100N/10884521196728/NELL-HOMECARE, BNPULSOKSYMETR, PM100N, PM100NKIT, PM100NKITCHDE, PM100NKITCHFR, PM100NKITDA, PM100NKITDE-2, PM100NKITES, PM100NKITFI, PM100NKITFR, PM100NKIT-FR, PM100NKITIT, PM100NKIT-NL, PM100NKITNO, PM100NKITPT, PM100NKITSV, PM100NKITUK, PM100N-10, PM100N-2XMAXN, PM100N-2XMAXN-CC, PM100N-3DYS-CC, PM100N-DYS, PM100N-HC, PM100N-MAXN, PM100N-MAXN-CC, PM100N-OXIAN-CC/PT00156589 - AR - Arabic, PT00156609 - AR - Arabic, PT00156588 - BG - Bulgarian, PT00156610 - BG - Bulgarian, PT00156586 - CS - Czech, PT00156612 - CS - Czech, PT00156585 - DA - Danish, PT00156613 - DA - Danish, PT00156578 - DE - German, PT00156625 - DE - German, PT00156577 - EL - Greek, PT00156626 - EL - Greek, PT00156509 - EN - English, PT00156328 - EN - English, PT00156563 - ES - Spanish, PT00156639 - ES - Spanish, PT00156583 - ET - Estonian, PT00156615 - ET - Estonian, PT00156582 - FI - Finnish, PT00156616 - FI - Finnish, PT00156581 - FR - French, PT00156617 - FR - French, PT00156587 - HR - Croatian , PT00156611 - HR - Croatian , PT00156576 - HU - Hungarian, PT00156627 - HU - Hungarian, PT00156575 - IT - Italian, PT00156628 - IT - Italian, PT00156580 - KA - Georgian, PT00156618 - KA - Georgian, PT00156591 - KO - Korean, PT00156642 - KO - Korean, PT00156573 - LT - Lithuanian, PT00156630 - LT - Lithuanian, PT00156574 - LV - Latvian, PT00156629 - LV - Latvian, PT00156584 - NL - Dutch, PT00156614 - NL - Dutch, PT00156572 - NO - Norwegian, PT00156631 - NO - Norwegian, PT00156571 - PL - Polish, PT00156632 - PL - Polish, PT00156570 - PT-BR - Brazilian Portuguese, PT00156633 - PT-BR - Brazilian Portuguese, PT00156569 - RO - Romanian, PT00156634 - RO - Romanian, PT00156567 - RU - Russian, PT00156635 - RU - Russian, PT00156565 - SK - Slovak, PT00156637 - SK - Slovak, PT00156564 - SL - Slovenian, PT00156638 - SL - Slovenian, PT00156566 - SR - Serbian, PT00156636 - SR - Serbian, PT00156562 - SV Swedish, PT00156640 -SV - Swedish, PT00156561 - TR - Turkish, PT00156641 - TR - Turkish, PT00156590 - ZH - SimplifIed Chinese, PT00156643 - ZH - SimplifIed Chinese; 10005941/10884521163454/PM100N-10, PM100N-2XMAXN, PM100N-2XMAXN-CC, PM100N-3DYS-CC, PM100N-DYS, PM100N-HC, PM100N-MAXN, PM100N-MAXN-CC, PM100N-OXIAN-CC, BEDSIDESP2KIT2, NELLSPO2, PM100N-HC, NELL-HOMECARE, ROEBEDSIDEKIT, BEDSIDESP2PT2, BEDSIDESP2NO2, BEDSIDESP2PL2, BEDSIDESP2NL2, BEDSIDESP2KITNM, BEDSIDESP2K2UK, BEDSIDESP2K2IT, BEDSIDESP2K2FR, BEDSIDESP2K2-2, BEDSIDEKITISR/PT00156645 - AR - Arabic, PT00156647 - BG - Bulgarian, PT00156649 - CS - Czech, PT00156650 - DA - Danish, PT00156656 - DE - German, PT00156657 - EL - Greek, PT00156324 - EN - English, PT00156673 - ES - Spanish, PT00156652 - ET - Estonian, PT00156653 - FI - Finnish, PT00156654 - FR - French, PT00156648 - HR - Croatian, PT00156658 - HU - Hungarian, PT00156659 - IT - Italian, PT00156655 - KA - Georgian, PT00156677 - KO - Korean, PT00156661 - LT - Lithuanian, PT00156660 - LV - Latvian, PT00156651 - NL - Dutch, PT00156662 - NO - Norwegian, PT00156664 - PL - Polish, PT00156666 PT-BR - Brazilian Portuguese, PT00156667 - RO - Romanian, PT00156668 - RU - Russian, PT00156671 - SK - Slovak, PT00156672 - SL - Slovenian, PT00156669 - SR - Serbian, PT00156674 - SV - Swedish, PT00156675 - TR - Turkish, PT00156676 - ZH - Simplified Chinese, NELL-SPO2-AD3+ - Canadian, NELL-SPO2-AD3 - Canadian; 10005941/A8845211634501; DLPM100N/10884521527607; DL10005941/10884521173293; DSPM100N/DSPM100N; 10005941-SG/10884521171534/BNINHLLCODE, BNINNEL100A, BNINNEL100AS, BNINNEL100AVJ, BNINNEL100AYS, BNINNELDYS, BNHKLIBRANEOSET, BNHKLIBRASET; DS10005941/DS10005941; 10005941J/10005941JP; 10005941JP/884521512019; 10005941JPN/884521188689. All serial numbers
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
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
Reason for Recall:: 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
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: ongoing

Product Information

Full Description:

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

Product Codes/Lot Numbers:

REF/UI-DI/Bundle Code/IFU Part Number: PM100N/10884521196728/NELL-HOMECARE, BNPULSOKSYMETR, PM100N, PM100NKIT, PM100NKITCHDE, PM100NKITCHFR, PM100NKITDA, PM100NKITDE-2, PM100NKITES, PM100NKITFI, PM100NKITFR, PM100NKIT-FR, PM100NKITIT, PM100NKIT-NL, PM100NKITNO, PM100NKITPT, PM100NKITSV, PM100NKITUK, PM100N-10, PM100N-2XMAXN, PM100N-2XMAXN-CC, PM100N-3DYS-CC, PM100N-DYS, PM100N-HC, PM100N-MAXN, PM100N-MAXN-CC, PM100N-OXIAN-CC/PT00156589 - AR - Arabic, PT00156609 - AR - Arabic, PT00156588 - BG - Bulgarian, PT00156610 - BG - Bulgarian, PT00156586 - CS - Czech, PT00156612 - CS - Czech, PT00156585 - DA - Danish, PT00156613 - DA - Danish, PT00156578 - DE - German, PT00156625 - DE - German, PT00156577 - EL - Greek, PT00156626 - EL - Greek, PT00156509 - EN - English, PT00156328 - EN - English, PT00156563 - ES - Spanish, PT00156639 - ES - Spanish, PT00156583 - ET - Estonian, PT00156615 - ET - Estonian, PT00156582 - FI - Finnish, PT00156616 - FI - Finnish, PT00156581 - FR - French, PT00156617 - FR - French, PT00156587 - HR - Croatian , PT00156611 - HR - Croatian , PT00156576 - HU - Hungarian, PT00156627 - HU - Hungarian, PT00156575 - IT - Italian, PT00156628 - IT - Italian, PT00156580 - KA - Georgian, PT00156618 - KA - Georgian, PT00156591 - KO - Korean, PT00156642 - KO - Korean, PT00156573 - LT - Lithuanian, PT00156630 - LT - Lithuanian, PT00156574 - LV - Latvian, PT00156629 - LV - Latvian, PT00156584 - NL - Dutch, PT00156614 - NL - Dutch, PT00156572 - NO - Norwegian, PT00156631 - NO - Norwegian, PT00156571 - PL - Polish, PT00156632 - PL - Polish, PT00156570 - PT-BR - Brazilian Portuguese, PT00156633 - PT-BR - Brazilian Portuguese, PT00156569 - RO - Romanian, PT00156634 - RO - Romanian, PT00156567 - RU - Russian, PT00156635 - RU - Russian, PT00156565 - SK - Slovak, PT00156637 - SK - Slovak, PT00156564 - SL - Slovenian, PT00156638 - SL - Slovenian, PT00156566 - SR - Serbian, PT00156636 - SR - Serbian, PT00156562 - SV Swedish, PT00156640 -SV - Swedish, PT00156561 - TR - Turkish, PT00156641 - TR - Turkish, PT00156590 - ZH - SimplifIed Chinese, PT00156643 - ZH - SimplifIed Chinese; 10005941/10884521163454/PM100N-10, PM100N-2XMAXN, PM100N-2XMAXN-CC, PM100N-3DYS-CC, PM100N-DYS, PM100N-HC, PM100N-MAXN, PM100N-MAXN-CC, PM100N-OXIAN-CC, BEDSIDESP2KIT2, NELLSPO2, PM100N-HC, NELL-HOMECARE, ROEBEDSIDEKIT, BEDSIDESP2PT2, BEDSIDESP2NO2, BEDSIDESP2PL2, BEDSIDESP2NL2, BEDSIDESP2KITNM, BEDSIDESP2K2UK, BEDSIDESP2K2IT, BEDSIDESP2K2FR, BEDSIDESP2K2-2, BEDSIDEKITISR/PT00156645 - AR - Arabic, PT00156647 - BG - Bulgarian, PT00156649 - CS - Czech, PT00156650 - DA - Danish, PT00156656 - DE - German, PT00156657 - EL - Greek, PT00156324 - EN - English, PT00156673 - ES - Spanish, PT00156652 - ET - Estonian, PT00156653 - FI - Finnish, PT00156654 - FR - French, PT00156648 - HR - Croatian, PT00156658 - HU - Hungarian, PT00156659 - IT - Italian, PT00156655 - KA - Georgian, PT00156677 - KO - Korean, PT00156661 - LT - Lithuanian, PT00156660 - LV - Latvian, PT00156651 - NL - Dutch, PT00156662 - NO - Norwegian, PT00156664 - PL - Polish, PT00156666 PT-BR - Brazilian Portuguese, PT00156667 - RO - Romanian, PT00156668 - RU - Russian, PT00156671 - SK - Slovak, PT00156672 - SL - Slovenian, PT00156669 - SR - Serbian, PT00156674 - SV - Swedish, PT00156675 - TR - Turkish, PT00156676 - ZH - Simplified Chinese, NELL-SPO2-AD3+ - Canadian, NELL-SPO2-AD3 - Canadian; 10005941/A8845211634501; DLPM100N/10884521527607; DL10005941/10884521173293; DSPM100N/DSPM100N; 10005941-SG/10884521171534/BNINHLLCODE, BNINNEL100A, BNINNEL100AS, BNINNEL100AVJ, BNINNEL100AYS, BNINNELDYS, BNHKLIBRANEOSET, BNHKLIBRASET; DS10005941/DS10005941; 10005941J/10005941JP; 10005941JP/884521512019; 10005941JPN/884521188689. All serial numbers

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2151-2025

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