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 is recalling SPINE PACK procedure kits that contain 3M Health Care Steri Drapes, which have been previously recalled. The recalled kits were distributed to medical facilities across multiple U.S. states.
DeRoyal Industries initiated a voluntary recall of 715 Lapinectomy Pack surgical kits (Ref 89-7198.11) distributed to 23 US states. The FDA Class II recall remains ongoing.
DeRoyal is recalling 88 endovenous procedure packs containing 3M Health Care Steri Drapes that have been recalled. The packs were distributed across 23 US states; consumers should stop using them immediately.
DeRoyal Industries is recalling GEO-MED KNEE ARTHROSCOPY PACK units containing 3M Health Care Steri Drapes due to a supplier recall. No reported illnesses or injuries.
DeRoyal Industries has issued a voluntary recall of 45 kits of the NEURO PACK medical device. The specific reason for the recall was not disclosed by the manufacturer.
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 initiated a voluntary recall of the DeRoyal EMERGENT TRAUMA PACK (6 kits). The recall affects units distributed across 23 U.S. states.
DeRoyal Industries Inc voluntarily recalled 45 units of the DeRoyal TOTAL HIP KIT (Lot 57686947, expiration 5/1/2025), distributed across 23 US states. The FDA classified this as a Class II recall, initiated November 3, 2022.
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 voluntarily recalled 159 kits of the NEURO PACK medical device. The specific reason for the recall was not disclosed in the FDA filing.
DeRoyal is recalling 18 EMERGENT TRAUMA PACK units distributed to 23 states. The specific reason for recall is not documented in available source materials.
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 has initiated a voluntary recall of 186 DeRoyal Podiatry Pack kits (Lot 56705544, exp. 6/1/2026) distributed across 22 US states. The specific reason is not provided in the source documentation.
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 OPEN SHOULDER PROCEDURE PACK RF kits are being recalled because they contain 3M Health Care Steri Drapes that have been subject to recall. A total of 42 kits are affected.
DeRoyal Industries Inc recalled 45 kits of its BASIC EYE PACK medical device distributed to healthcare facilities across the United States. The FDA classified this as a voluntary Class II recall.
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 CATARACT PACK surgical kits are subject to a voluntary Class II recall affecting 108 kits across 23 U.S. states. The specific reason for the recall is not provided in available documentation.
DeRoyal Industries is recalling 48 kits of EYE TRAY procedure packs that contain 3M Health Care Steri Drapes which have been recalled.
DeRoyal Industries Inc is voluntarily recalling 156 kits of the TRANS CANAL PACK medical device distributed across 23 U.S. states.
DeRoyal Industries recalled 270 NEURO PACK kits (REF 89-10682.02) distributed across 23 US states. The specific reason for the recall was not disclosed in the FDA notice.
DeRoyal Industries initiated a Class II recall of 100 shoulder arthroscopy surgical kits distributed across 23 U.S. states. The specific defect has not been publicly disclosed in FDA records.
DeRoyal Industries Inc is voluntarily recalling 130 kits of the DeRoyal BASIC PACK medical device across 23 U.S. states due to an FDA Class II recall.
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 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.
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