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 Inc voluntarily recalled approximately 460 units of GEO-MED BIOPSY TRAY distributed across 23 US states. The specific reason for the recall is not disclosed in available FDA documentation.
DeRoyal TOTAL KNEE PACK surgical kits are being recalled as a Class II device recall. The specific reason for recall is not documented in available source records.
DeRoyal Industries initiated a Class II recall of 495 endovascular tracepack kits distributed across 23 U.S. states due to an unspecified manufacturing concern.
DeRoyal Industries Inc voluntarily recalled 57 kits of the DeRoyal GU PACK medical device. The specific reason for the recall was not provided in the available source documentation.
DeRoyal Industries is voluntarily recalling 440 kits of its Cataract Pack (Model 89-8650.10, Lot 55749537). The FDA classified this as a Class II device recall, but the specific reason is not provided in the notice.
DeRoyal Industries voluntarily recalled 530 cataract surgical packs (Lot 57755800) classified as FDA Class II. The recall affects multiple U.S. states.
DeRoyal is recalling 63 ACDF surgical implant kits distributed to 23 US states. This is a voluntary, Class II recall announced November 2022, with no reported illnesses or injuries.
DeRoyal Industries is voluntarily recalling 834 GEO-MED Cataract Pack kits (REF 89-5790.08) distributed across 23 US states. The FDA classified this as a Class II recall, though the specific reason has not been disclosed.
DeRoyal Industries initiated a voluntary recall of its Shoulder Arthroscopy Pack (32 kits, Lot 56865450) distributed to healthcare facilities in 23 U.S. states. The specific reason for recall is not disclosed in FDA documentation.
DeRoyal TLIF procedure packs containing recalled 3M Health Care Steri Drapes are being recalled. The affected packs were distributed across multiple U.S. states.
DeRoyal Industries has voluntarily recalled 90 kits of laminectomy spinal fusion surgical packs. The recall affects units distributed across 23 U.S. states. The specific reason for recall was not disclosed in available materials.
DeRoyal Industries Inc is recalling 180 kits of the NEURO SPINE BACK PACK PGYBK distributed across multiple U.S. states. The specific reason for the recall is not documented in the agency filing.
DeRoyal Industries is recalling 918 PICC line procedure packs containing 3M sterile drapes that were separately recalled. The affected kits were distributed across 23 U.S. states to healthcare facilities.
DeRoyal Industries Inc initiated a voluntary recall of 93 kits of the DeRoyal NEURO PACK affecting 23 U.S. states. The recall affects three lot numbers with March 1, 2025 expiration.
DeRoyal Industries voluntarily recalled 49 kits of the GEO-MED TOTAL KNEE PACK A & B distributed across 23 U.S. states. The specific reason for the recall is not detailed in the FDA notice.
DeRoyal Industries is recalling 108 kits of Cannulated Hip Procedure Packs because they contain 3M Steri Drapes that have been recalled. Affected lots were distributed across 23 U.S. states.
DeRoyal Industries initiated a voluntary recall of 32 kits of its Shoulder Pack medical device distributed across 23 U.S. states. The specific reason for the recall was not provided in the source documentation.
DeRoyal Industries is recalling LAMINECTOMY PACK surgical kits (Lot 56388471) distributed in multiple US states. Healthcare facilities with affected kits should verify their inventory and contact the manufacturer for guidance.
DeRoyal Industries Inc has recalled 350 kits of the DeRoyal FOOT PACK medical device in a Class II FDA recall. The specific reason for the recall was not publicly disclosed in available agency records.
DeRoyal is recalling 144 shoulder arthroscopy procedure packs that contain recalled 3M Health Care Steri Drapes. The packs were distributed across 23 U.S. states.
DeRoyal Industries voluntarily recalled 75 units of its PACEMAKER ICD PACK (REF 89-10216.06, Lot 57898501) distributed across 23 US states on November 3, 2022.
DeRoyal Industries is recalling 48 kits of GEO-MED Lower Extremity Packs because they contain 3M Health Care Steri Drapes that have been recalled. The affected kits were distributed to healthcare facilities across the United States.
DeRoyal Industries has voluntarily recalled 162 NEURO PACK neurological medical device kits distributed across 23 U.S. states. The reason for the recall was not disclosed by the manufacturer.
DeRoyal Industries has recalled 480 units of its BIOPSY PACK (REF 89-9614.07) in a voluntary, firm-initiated recall affecting 23 US states. The specific reason for the recall has not been disclosed.
DeRoyal BASIC EYE PACK (Lot 57389942) was voluntarily recalled as a Class II medical device on November 3, 2022. The specific reason for recall is not disclosed in the FDA notice.