FDA (Devices) recall action 91134
The FDA (Devices) publishes a recall like this one as 156 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 156 pages.
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DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
DeRoyal Industries initiated a voluntary recall of 75 genitourinary (GU) pack kits (Lot 55971461, exp. 5/1/2024). The specific reason for recall is not disclosed in available FDA documentation.
DeRoyal Industries initiated a voluntary recall of EMERGENT TRAUMA PACK kits (18 units) distributed to hospitals and medical facilities across 23 US states. The specific reason for the recall was not disclosed in the FDA notification.
DeRoyal Industries is voluntarily recalling 51 units of the DeRoyal TOTAL HIP KIT (Lot 56187960 and 57031051) distributed to healthcare facilities across 23 US states.
DeRoyal procedure packs containing defective 3M Steri Drapes have been recalled and distributed across the United States.
DeRoyal procedure kits containing recalled 3M Health Care Steri Drapes are being recalled. Affected units were distributed across multiple US states and are identifiable by Lot 57748706.
DeRoyal Industries is recalling 184 GEO-MED PODIATRY PACK kits distributed across 23 U.S. states because they contain 3M Health Care Steri Drapes that were previously recalled. The affected kits have specific lot numbers with expirations through February 2025.