Kayserbetten Gmbh & Co. Kg medical device recall: Pediatric care bed

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).

What the classification means

• Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.

About this recall

The firm started this recall on May 4, 2026. FDA classified it 31 days later, on Jun 4, 2026. Distribution reported by FDA: Distribution US Nationwide and Canada.

Recalled products (1)

• Z-2212-2026 Class I Ongoing

  Pediatric care bed; Product Designation: KayserBett IDA;

  Codes / lots: 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,…

  Quantity: 372 units