Category
FDA recalls of medical devices including diagnostics, implants, and consumer health hardware.
Medical device recalls are the FDA's highest-volume stream. They cover implantable devices like pacemakers and joint replacements, hospital diagnostics and lab analyzers, surgical instruments, software-as-a-medical-device, and consumer-facing hardware like CPAP machines, blood-pressure cuffs, and glucose monitors. The volume comes from the wide range of products in scope and from the FDA's broad definition of 'corrective action' — software updates, IFU revisions, and labeling corrections all show up as recalls.
For Class I device recalls, the device's defect creates a reasonable risk of serious injury or death — these are the urgent ones. Class II covers issues that may cause temporary or medically reversible harm, often around accuracy or calibration. Class III is for products that don't comply with FDA rules but pose no real safety risk; in practice many software-update letters are Class III.
If you depend on a recalled device for ongoing care, don't disconnect or stop using it before talking to the prescribing clinician — interrupting therapy for a CPAP or a continuous glucose monitor can be more dangerous than the recall it's responding to. Almost every device recall offers a remedy that doesn't require you to surrender the device first.
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 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.
DeRoyal Industries is recalling EYE TRAY procedure packs containing recalled 3M Health Care Steri Drapes. The recall affects 180 kits distributed across multiple U.S. states.
DeRoyal Industries is recalling 264 units of the ORTHO SPINE BACK PACK orthopedic device across 23 U.S. states as a voluntary, Class II recall. The specific reason for the recall is not provided in the available notice.
DeRoyal Industries issued a voluntary recall of 6 kits of DeRoyal CRANI PACK devices (Lot 56388307) distributed across 23 U.S. states. The specific reason for recall was not disclosed in available documentation.
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 initiated an ongoing voluntary Class II recall of 204 kits of the DeRoyal CARDIAC LINEN PACK distributed to 23 U.S. states.
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 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 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 Inc has voluntarily recalled shoulder arthroscopy surgical packs distributed across 22 US states. The specific reason for recall was not disclosed in the FDA notification.
DeRoyal Industries Inc is voluntarily recalling 240 kits of the PORT PACK PGYBK medical device distributed across 22 U.S. states. The specific reason for recall is not disclosed in available source material.
DeRoyal Industries initiated a voluntary recall of 243 GEO-MED Upper Extremity Pack kits distributed across 23 US states. The specific reason for the recall is not available in the source material.
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 is voluntarily recalling 76 GEO-MED PODIATRY PACK kits distributed across 23 U.S. states. The specific reason for this Class II recall is not detailed in the public notice.
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 has voluntarily recalled 117 TRACECART shoulder arthroscopy kits distributed across 23 U.S. states. No illnesses or injuries have been reported. The specific reason for the recall is not disclosed in available FDA documentation.
DeRoyal Industries initiated a voluntary recall of 12 kits of Lumbar Disc Pack medical devices distributed across 23 US states. Specific hazard details from the FDA are not available in the source data.
DeRoyal is recalling 336 TRACECART surgical kits distributed across 23 US states. This is a voluntary, Class II recall initiated by the manufacturer.
DeRoyal Industries voluntarily recalled 360 kits of its BIOPSY PACK (Lot 57686568) distributed across 22 U.S. states. The specific reason for the recall is not specified in available FDA documentation.
DeRoyal BASIC NEURO PACK procedure kits are recalled because they contain 3M Health Care Steri Drapes that were previously recalled. 108 kits were distributed across multiple US states.
DeRoyal Industries Inc is recalling 60 NEURO PACK medical device kits (Lot 56927104, expires May 2026) distributed across 23 US states. The reason for recall was not provided in the source documentation.
DeRoyal Industries is voluntarily recalling 1,100 kits of pain tray devices distributed across 23 US states. The FDA classified this as a Class II recall.
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