Pediatric care bed; Product Designation: KayserBett IDA;
FDA Device Recall #Z-2212-2026 — Class I — May 4, 2026
Recall Summary
| Recall Number | Z-2212-2026 |
| Classification | Class I — Serious risk |
| Date Initiated | May 4, 2026 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | KAYSERBETTEN GMBH & CO. KG |
| Location | Bad Fallingbostel |
| Product Type | Devices |
| Quantity | 372 units |
Product Description
Pediatric care bed; Product Designation: KayserBett IDA;
Reason for Recall
If the adjustment functions of the hand control, as instructed in the Manual, are not locked with the provided key when the patient (child) is unattended, there is an increased risk that the patient (child) or third parties (children) will operate the hand control and trap themselves or others under the bed frame or between the bed frame and the floor. This can lead to serious injuries or even death of the patient (child) or third parties (children).
Distribution Pattern
Distribution US Nationwide and Canada.
Lot / Code Information
Product Designation: KayserBett IDA; UDI-DI: 426038961IDAGU; Serial Number: 386, 387, 388, 389, 390, 391, 392, 635, 636, 637, 638, 639, 641, 642, 643, 644, 645, 646, 647, 1072, 1073, 1074, 1075, 1076, 1077, 1078, 1079, 1080, 1081, 1082, 1083, 1085, 1086, 1087, 1088, 1089, 1090, 1110, 1111, 1446, 1447, 1448, 1449, 1648, 1649, 1950, 1975, 1976, 1982, 1983, 1998, 2001, 2003, 2004, 2337, 2338, 2339, 2340, 2341, 2342, 2343, 2344, 2345, 2396, 2763, 2764, 2765, 2766, 2767, 2770, 2771, 2772, 2773, 2774, 3087, 3088, 3089, 3090, 3091, 3092, 3167, 3299, 3300, 3301, 3302, 3303, 3304, 3305, 3306, 3309, 3310, 3311, 3312, 3313, 3314, 3740, 3741, 3760, 4223, 4232, 4233, 4234, 4235, 4236, 4237, 4239, 4240, 4242, 4243, 4244, 4245, 4246, 4247, 4248, 4249, 4250, 4567, 4568, 4569, 4570, 4571, 4572, 4573, 4574, 4575, 4576, 4577, 4578, 4579, 4580, 4581, 4582, 4583, 4584, 4986, 5238, 5254, 5255, 5256, 5257, 5258, 5259, 5637, 5919, 5920, 5921, 5922, 5923, 5924, 5925, 5926, 5937, 5938, 5939, 5940, 5948, 6332, 6338, 6339, 6340, 6341, 6342, 6343, 6344, 6345, 6346, 6347, 6351, 6355, 6795, 6796, 7176, 7177, 7178, 7179, 7180, 7181, 7182, 7183, 7184, 7185, 7186, 7187, 7188, 7189, 7190, 7191, 7192, 7193, 7194, 7195, 7617, 7618, 7619, 7620, 7621, 7622, 7623, 8242, 8243, 8244, 8245, 8588, 8589, 8590, 8591, 8592, 8593, 8594, 8595, 8596, 8597, 8598, 8599, 8600, 8601, 8602, 8603, 8608, 8609, 8691, 8704, 8912, 8921, 8922, 8923, 8924, 8925, 8926, 8927, 8928, 8929, 8930, 9725, 9726, 9727, 10350, 10351, 10352, 10819, 10820, 10821, 10822, 10823, 10824, 10825, 11186, 11367, 11368, 11369, 11370, 11371, 11372, 11797, 11798, 11799, 11800, 11801, 11802, 11803, 11804, 11805, 11806, 11807, 11808, 12247, 12248, 12249, 12250, 12251, 12252, 12253, 12254, 12255, 12256, 12257, 12397, 12398, 12399, 12782, 12783, 12963, 12964, 12965, 12966, 12967, 12968, 12969, 12970, 12971, 12972, 13486, 13487, 13488, 13489, 13490, 13491, 13492, 13493, 13494, 13495, 13496, 13497, 13912, 13913, 13914, 13915, 13916, 13917, 13918, 14942, 14944, 14952, 14953, 15912, 15913, 15914, 16403, 16404, 16405, 16406, 16407, 16408, 16409, 16410, 16411, 16984, 16985, 16986, 16987, 16988, 16989, 16990, 16991, 16992, 16993, 16994, 17577, 17578, 17579, 17580, 17581, 17582, 17583, 17584, 17585, 17586, 17587, 18494, 19112, 19113, 19114, 20151, 20152, 20153, 20154, 20155, 20156, 20157, 20158, 20963, 20964, 20965, 20966, 20967, 20968, 20969, 20970, 20972, 21192, 21193, 21194;
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.