Recall Z-1580-2026 ยท FMS Bed, Pediatric Open Hospital
Stryker Medical Division of Stryker Corporation
Cub Pediatric Crib, Model FL19H
| Date | Mar 19, 2026 (initiated Feb 18, 2026) |
| Status | Open, Classified |
| Reason | Cribs sold in the USA are missing two access door warning labels. |
| Root cause | Under Investigation by firm |
| Action | On February 18. 2026, the firm notified customers through IMPORTANT MEDICAL DEVICE CORRECTION letters. Customers were notified of the missing warning labels, which read, "WARNING: Never leave a child unsupervised when the movable slide is open or not secured Refer to Instructions for Use for product care, maintenance, and cleaning." Customers were instructed to locate the units listed on the attached business reply form and identify the address where they can be serviced, and return the completed form to Stryker. Stryker will then contact consignees to arrange for the application of the mis |
| Quantity | 590 |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.