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跟进:Medline病床召回11月13日更新维修更换方案:已报告7例死亡与35例重伤,涉全部品牌病床与配件

2026-11-13 · 医疗 · GSM News
跟进:Medline病床召回11月13日更新维修更换方案:已报告7例死亡与35例重伤,涉全部品牌病床与配件

Medline 公司11月13日经美国食品药品管理局发布更新公告,就其品牌病床、护栏、床垫与配件的召回给出维修与更换计划的新说明。公告的产品类型为医疗器械,召回原因为潜在火灾风险与卡陷风险。

这起召回于2026年10月14日启动,公司同时对全部 Medline 品牌病床、护栏、床垫与配件实施市场退出与停产。公告称,截至2026年11月8日,公司收到与上述问题相关的7例死亡与35例重伤报告。

涉事产品在2011年至2026年间在美国与加拿大分销,购买方包括耐用医疗设备供应商、长期护理机构与直接购买的终端用户。召回范围为市面上全部 Medline 品牌病床及配套护栏、床垫与配件。

按10月24日更新的客户信,病床在维修或更换前可按更新说明继续使用,说明包括立即拔掉病床电源插头、只在调整病人位置时插电、不用延长线,以及在可行的情况下由第二人协助使用与移动病床。

公司称,部分现有病床可维修,修好的病床可按使用说明继续使用;判定不可维修的,公司将与客户商定更换或按原购买价全额或部分退款,相关安排可能适用于近5年内购买的某些产品。公司将陆续发放新的维修与更换客户指南。

公告列出的咨询渠道为向原购买供应商询问资格认定,直接向 Medline 购买者可致电召回客服 800-950-0128 按7,服务时间为中部时间周一至周五上午8时至下午5时。不良反应或质量问题可向食品药品管理局 MedWatch 不良事件报告计划报告。

Follow-up: Medline Bed Recall Updated on November 13 With a Repair and Replace Program: Seven Deaths and 35 Serious Injuries Reported, Covering All Medline Brand Beds and Accessories

Medline issued an updated announcement through the Food and Drug Administration on November 13, 2026, sharing new customer communication on the recall of its brand beds, rails, mattresses and accessories, with instructions for continued use and options for repair, replacement and full or partial refund of the original purchase price. The products are medical devices, and the recall reason is a potential fire hazard and entrapment risk.

Medline initiated the recall, market exit and discontinuation on October 14, 2026. As of November 8, 2026, the company had received reports related to seven deaths and 35 serious injuries associated with these issues.

The products were distributed in the United States and Canada between 2011 and 2026 to durable medical equipment providers, long-term care facilities and end users directly. The recall includes all Medline brand beds and associated rails, mattresses and accessories on the market.

Under the updated instructions, beds may remain in use until repaired or replaced if they are unplugged from electrical outlets, plugged in only while repositioning a patient, not powered through extension cords, and used with a second person assisting whenever possible.

Certain existing beds may be eligible for repair, the company said. If Medline determines that beds and accessories are not eligible for repair, it will work with customers on replacement or a full or partial refund, which may be available for certain products purchased in the last five years. Customers can contact Medline Recall Customer Service at 800-950-0128, option 7, between 8 a.m. and 5 p.m. Central time, Monday through Friday, and adverse reactions can be reported to the FDA's MedWatch program.

来源:美国食品药品管理局

发布:GSM·美国(发布链接)

图片来源:图:病房内的现代病床(资料图,非涉事Medline产品照片)。公共领域,经 Wikimedia Commons。 / Photo: A modern hospital bed in a patient room (file photo; not the recalled Medline product). Public domain, via Wikimedia Commons.

GSM Global · 本篇英文版 English edition of this story

本事件进展Story Timeline
  1. 2026-10-29 14:02FDA发布早期警报:Medline全部品牌病床撤下或纠正,已报告2人死亡、16人重伤,涉及火灾与卡陷窒息风险
  2. 2026-11-13 03:01跟进:Medline病床召回11月13日更新维修更换方案:已报告7例死亡与35例重伤,涉全部品牌病床与配件本篇
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