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 Class II recall of 495 endovascular tracepack kits distributed across 23 U.S. states due to an unspecified manufacturing concern.
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 voluntarily recalls GEO-MED Podiatry Pack medical device kits distributed across 23 US states. The specific reason for recall is not detailed in available source materials.
DeRoyal Industries initiated a voluntary Class II recall of 70 kits of its Breast Augmentation Pack distributed across 23 US states. The specific reason for the recall is not stated in available FDA materials.
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 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 recalled 64 DeRoyal Retinal Pack kits (Lot 57000221, Lot 57413324) distributed across 23 U.S. states. The specific reason for the recall was not disclosed.
A voluntary recall of 45 DeRoyal ACDF Pack surgical implant kits affects multiple US states. The recall reason was not specified in the available notice.
DeRoyal Industries has recalled the DeRoyal CATARACT PACK (368 kits) in a voluntary Class II recall. Affected lot numbers are 55990451 and 56615717 with expiration 08/01/2024.
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 is recalling its EXTREMITY TRAY procedure packs because they contain recalled 3M Health Care Steri Drapes. The affected kits are distributed across multiple U.S. states.
DeRoyal Industries is recalling 180 kits of laminectomy spinal fusion surgical packs distributed across 23 states. The reason for recall is not specified in the available source.
DeRoyal SPINE PACK kits have been recalled because they contain 3M Health Care Steri Drapes components that have been previously recalled. Affected units should not be used.
DeRoyal Industries Inc voluntarily recalled 102 kits of its podiatry pack (Lot 57593741, exp. 1/1/2027). The recall affects 22 US states; the specific reason is not detailed in available source material.
DeRoyal Industries voluntarily recalled 1,196 posterior spine surgical packs distributed across 23 states. The specific reason for the recall was not documented.
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 initiated a voluntary recall of 560 biopsy pack kits (lot 56094211) distributed across multiple US states. The specific reason for the recall was not documented in the available source.
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 initiated a voluntary Class II recall of 217 kits of its DeRoyal Foot Pack (REF 89-9252.07). The recall affects multiple U.S. states.
DeRoyal Industries Inc is recalling 876 kits of the DeRoyal SHOULDER PACK (REF 89-6830.13) due to an unspecified reason for recall. The affected product was distributed across 23 U.S. states.
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 Inc is voluntarily recalling the DeRoyal CUSTOM NEURO PACK (Lot 57745880) distributed across multiple U.S. states. The specific reason for the recall is not disclosed.
DeRoyal Industries is recalling its BASIC NEURO PACK procedure packs because they contain 3M Health Care Steri Drapes that have been recalled. The recall affects 96 kits (lot 57287655, expires 9/1/2026) distributed to 23 states.
DeRoyal Industries voluntarily recalled 72 kits of its EYE PACK medical device. The affected lot (Lot 57344921, exp. November 1, 2026) was distributed across multiple U.S. states.
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.