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 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 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 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 36 kits of the LAMI/CRANI PACK (lot numbers 56219159 and 56593562, expiring 4/1/2026) distributed across 23 US states. This is a voluntary Class II device recall; the specific reason was not disclosed in available documentation.
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 is recalling 90 ophtalmology procedure kits because they contain 3M Steri Drapes that have been recalled. The affected kits were distributed across multiple U.S. states.
STRADIS HEALTHCARE dental procedure trays may have incompletely sealed outer bags that could compromise sterility. The recall affects units distributed nationwide in the US and Canada.
DeRoyal Industries recalled 68 DeRoyal KIT HEART B PACK units (Class II, voluntary). The specific reason for the recall is not documented in the source.
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 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 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 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 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 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 has voluntarily recalled 180 units of its Biopsy Pack (Lot 56842514, exp. 8/1/2026) following an FDA Class II classification. The product was distributed across 23 U.S. states.
DeRoyal Industries recalled 28 SHOULDER KIT units due to an unspecified Class II device defect. The affected lot numbers were distributed across 23 U.S. states between November 2022 and April 2025.
DeRoyal Industries is recalling 135 surgical procedure kits containing recalled 3M Health Care Steri Drapes. The affected kits were distributed to 23 U.S. states.
DeRoyal Industries initiated a voluntary Class II recall of its Lumbar Fusion Pack (51 kits) distributed across 23 US states. The specific reason for the recall was not documented in available records.
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 has recalled 192 kits of the DeRoyal GU Robotic Pack (Lot 57387066, expires 9/1/2026) distributed across 23 U.S. states. The FDA classified this as a Class II recall.
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 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 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 has voluntarily recalled 75 DeRoyal UNIVERSAL PACK kits (Ref 89-9558.03) distributed across 23 US states. The specific reason for the recall has not been disclosed in available 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.
Looking for a different category? Browse all recalls.