ZOLL 731 Ventilator — Class I medical device recall Z-2130-2024
Ongoing recall by ZOLL Medical Corporation, reported 2024-06-26, distributed nationwide. Operator's Guide & Quick Reference Guide (QRG) ZOLL 731 Ventilator for MRI Compatible Devices. Patient Safety
| Recall number | Z-2130-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ZOLL Medical Corporation, Chelmsford, MA, United States |
| Recall initiated | 2024-04-30 |
| Classified | 2024-06-20 |
| Reported by FDA | 2024-06-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AU, BD, BE, BH, BO, BR, CA, CH, CN, CO, CZ, DE, ES, GB, GR, GT, HK, HR, HU, ID, IL, IN, IQ, IT, JP, KR, LB, MX, MY, NL, NZ, OM, PA, PH, PK, PL, PT, QA, RO, SA, SG, TH, TR, TW, VN |
| Quantity | 2,361 units |
| UPC / GTIN / UDI-DI | 00847946020767, 00847946020910, 00847946023430, 00847946023454, 00847946024185, 00847946034351, 00847946036867, 00847946036874, 00847946036881, 00847946036959, 00847946049850, 00847946050665 |
| Model numbers | 799-EGL2-02, 799-EGL2-02-01, 799-EGL2-02-04, 799-EGL2-02-05, 799-EGL2-02-08, 799-EGL2-02-10, 799-EGL2-02-11, 799-EGL2-02-15, 799-EGL2-02-16, 799-EMBP, 799-EMBP-05-01, 799-EMBP-05-02, 799-EMBP-05-08, 799-EMBP-05-10, 799-EMBP-05-11, 799-EMBP-05-12, 799-EMBP-05-16, 799-EMBP-05-23, 799-EMVP-05, 799-EMVP-05-01, 799-EMVP-05-05, 799-EMVP-05-10, 799-EMVP-05-15, 799-EMVP-05-16, 906-0731-01 and 1 more |
Product
ZOLL 731 Ventilator (EMV+, AEV, Eagle II) - for MRI Compatible Devices - Operator's Guide and Quick Reference Guide (QRGs) as follows: Part Numbers: 1. 799-EGL2-02 2. 799-EGL2-02-01 3. 799-EGL2-02-04 4. 799-EGL2-02-05 5. 799-EGL2-02-08 6. 799-EGL2-02-10 7. 799-EGL2-02-11 8. 799-EGL2-02-15 9. 799-EGL2-02-16 10. 799-EMBP-05-01 11. 799-EMBP-05-02 12. 799-EMBP-05-08 13. 799-EMBP-05-10 14. 799-EMBP-05-11 15. 799-EMBP-05-12 16. 799-EMBP-05-12-68 17. 799-EMBP-05-16 18. 799-EMBP-05-23 19. 799-EMVP-05 20. 799-EMVP-05-01 21. 799-EMVP-05-05 22. 799-EMVP-05-10 23. 799-EMVP-05-15 24. 799-EMVP-05-16 Manual Part Numbers 906-0731-01; 9650-002365-01 (US); 906-0731-01-05 (CAN); 906-0731-01-10; 9650-0002363-01; 906-0731-01 (Commercial); 906-0731-03 (Military); 9650-0002363-01; 9650-0002363-05; 906-0731-01; 906-0731-01-05 (CAN); 906-0731-01-04; 906-0731-01-05; 906-0731-01-08; 906-0731-01-10; 906-0731-01-11; 906-0731-01-15; 906-0731-01-16; 9650-0002363-01; 9650-0002363-02; 9650-0002363-08; 9650-0002363-10; 9650-0002363-11; 9650-0002363-12; 9650-0002363-16; 9650-0002363-23; 906-0731-01 (Commercial); 906-0731-03 (Military); 9650-0002363-01; 9650-0002363-05; 9650-0002363-10; 9650-0002363-15; 9650-0002363-16 Quick Reference Guide (QRG) Part Numbers: 907-0731-04; 9652-000499-01; 9652-000511-01; 907-0731-04; 9652-000511-01; 907-0731-04; 9652-000499-01; 9652-000499-04; 9652-000499-08; 9652-000499-10; 9652-000499-11; 907-0731-04; 9652-000499-16; 9652-000511-01; 9652-000511-02; 9652-000511-08; 9652-000511-10; 9652-000511-11; 9652-000511-12; 9652-000511-16; 9652-000511-23; 907-0731-04; 9652-000511-01; 9652-000511-05; 9652-000511-10; 9652-000511-15; 9652-000511-16
Reason for recall
Operator's Guide & Quick Reference Guide (QRG) ZOLL 731 Ventilator for MRI Compatible Devices. Patient Safety Ventilator MRI information omitted from the manuals. Update to the instructions ensures safe distance from the MRI to ensure proper function of the ventilator and reduce the risk of delay in ventilator therapy
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2130-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.