# FDA recall Z-2151-2025

> **Covidien** · Class II · device recall initiated 2025-06-23.

## Product

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

## 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

## Distribution

Worldwide - US Nationwide distribution including in the states of MS, TX, FL, SC, VA, AZ, PA, MN, OH, CA, MI, CO, KS, IN, IL, TN, MO, IA, OK, WI, AK, NY, MD, AL, WV, GA, NC, AR, WA, SD, KY, DE, NJ, UT, NV, MA, MT, GU, NE, LA, HI, OR, RI, NH, ND, NM, ME, CT, DC, WY and the countries of Algeria, Andorra, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belgium, Bermuda, Bhutan, Bolivia, Bosnia And Herzegovina, Botswana, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, French Guiana, Germany, Ghana, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, India, Indonesia, Iran, Islamic Republic Of, Ireland, Isle of Man, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Maldives, Malta, Mauritius, Mexico, Montenegro, Morocco, Myanmar, Namibia, Netherlands, New Zealand, North Macedonia, Norway, Oman

## Key facts

- **Recall number:** Z-2151-2025
- **Recalling firm:** Covidien
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-06-23
- **Report date:** 2025-07-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Boulder, CO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2151-2025

## Citation

> AI Analytics. FDA recall Z-2151-2025. Retrieved 2026-09-04 from https://api.ai-analytics.org/recall/Z-2151-2025. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*