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 recall of its POSTERIOR LAMI MICRODISC PACK, an FDA Class II medical device. The reason for this recall was not disclosed in available documentation.
DeRoyal Industries recalled 48 units of its shoulder pack medical device (Lot 57755295) on November 3, 2022. The specific reason for the recall was not disclosed in available documentation.
DeRoyal Industries Inc is voluntarily recalling 156 kits of the TRANS CANAL PACK medical device distributed across 23 U.S. states.
DeRoyal cataract procedure packs containing recalled 3M Health Care Steri Drapes are being recalled. The recall includes 520 kits distributed to healthcare facilities.
DeRoyal Industries Inc has recalled 19 anterior approach total hip replacement surgical kits distributed across 23 U.S. states. This Class II recall was initiated voluntarily by the manufacturer.
DeRoyal Industries is recalling 288 BASIC NEURO PACK medical device kits distributed across 23 U.S. states. The reason for the recall is not specified in available documentation.
DeRoyal Industries is recalling 27 kits of its Spinal Fusion Pack due to inclusion of recalled 3M Health Care Steri Drapes. The affected lots were distributed across 23 U.S. states.
DeRoyal Industries initiated a voluntary recall of 30 kits of a laparoscopic robotic surgical tray (Model 89-7063.11). The reason for the recall is not specified in available FDA records.
DeRoyal Industries Inc recalled 243 SPINE PACK medical device kits distributed across 23 US states as a Class II FDA recall. The specific reason for the recall is not detailed in the available notice.
DeRoyal Industries voluntarily recalled 2,280 myelogram pack kits across 23 U.S. states. No specific reason for the recall was provided in the official notice.
DeRoyal Industries Inc is recalling 360 units of LUMBAR/CERVICAL PACK (Reference 89-9521.11) medical devices. The firm initiated this voluntary Class II recall. No illnesses or injuries have been reported.
DeRoyal Industries Inc voluntarily recalls 105 kits of DeRoyal Foot Pack (Lot 57899862, exp 3/1/2025) distributed across 23 U.S. states. Affected customers should contact the firm for recall instructions.
DeRoyal Industries has issued a voluntary recall of 150 kits of the DeRoyal PAIN TRAY (Model 89-10464.03, Lot 57752107, expires 12/1/2026). The specific reason for the recall was not disclosed in the FDA notice.
DeRoyal Industries has initiated a voluntary recall of 36 kits of DeRoyal Cannulated Hip Pack medical devices distributed across 23 US states. No injuries or illnesses have been reported.
DeRoyal Industries Inc is recalling 14 shoulder kits (Lot 56580884, expiring 12/1/2024) distributed to healthcare facilities in 23 states. The company initiated a voluntary Class II recall with the FDA.
DeRoyal Industries has voluntarily recalled 35 kits of DeRoyal FACIAL PACK PGYBK medical devices. The FDA classified the recall as Class II, and it remains ongoing.
DeRoyal Industries is recalling approximately 1,220 cataract procedure packs that contain recalled 3M Health Care Steri Drapes. The affected kits were distributed to healthcare facilities across 23 U.S. states.
DeRoyal Industries initiated a Class II recall of its HEART B PACK medical device kit affecting 68 units distributed across 23 US states (Lot 56613762, expires 6/1/2026). The specific reason for recall is not available in source documentation.
DeRoyal is recalling 336 TRACECART surgical kits distributed across 23 US states. This is a voluntary, Class II recall initiated by the manufacturer.
DeRoyal procedure packs distributed across multiple U.S. states are being recalled because they contain previously recalled 3M Steri Drapes. Affected healthcare facilities should stop using the packs and contact the manufacturer.
DeRoyal extremity pack kits are subject to a voluntary FDA Class II recall. Three production lots distributed across 23 states are affected.
DeRoyal Industries Inc initiated a voluntary recall of 165 kits of GEO-MED Plastic Hand Pack RF distributed across 23 US states. The specific reason for the Class II recall was not provided in the FDA notice.
DeRoyal Industries Inc is recalling 102 kits of the GEO-MED PLASTIC HAND PACK RF. The reason for the recall is not publicly specified. The recall affects 23 US states and was voluntarily initiated by the manufacturer.
DeRoyal Industries is recalling 72 kits of TRACECART POSTEROR LAMI MICRODISC TRACECART devices distributed across 23 U.S. states in a voluntary Class II recall initiated by the manufacturer.
DeRoyal Industries initiated a voluntary recall of 18 DeRoyal Hand Pack medical device kits (Lot 56615021) distributed across 23 U.S. states. The specific reason for the recall is not provided in the available source material.