The Spirit Plus Bed — Class II medical device recall Z-0438-2019
Terminated recall by Stryker Medical Division of Stryker Corporation, reported 2018-11-21, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. The beds with the high rail side rail option may not be complaint with IEC 60601-2-52/C1:2010. There is a pote
| Recall number | Z-0438-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Medical Division of Stryker Corporation, Portage, MI, United States |
| Recall initiated | 2018-10-08 |
| Classified | 2018-11-09 |
| Reported by FDA | 2018-11-21 |
| Terminated | 2020-04-28 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WY |
| Countries outside the US | CA |
| Quantity | 20,030 total |
| Serial numbers | 021797, 021798, 021799, 021800, 021801, 021802, 021803, 021804, 021805, 021806, 021807, 021808, 021809, 021810, 021811, 021812, 021813, 021814, 021815, 021816, 021817, 021818, 021819, 021820, 021821 and 475 more |
| Model numbers | 5600 |
Product
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
Reason for recall
The beds with the high rail side rail option may not be complaint with IEC 60601-2-52/C1:2010. There is a potential risk of entrapment.
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-0438-2019. 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.