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.
A HENRY SCHEIN extremity pack surgical kit is being recalled because its outer bag may not be completely sealed, which could compromise the sterility of the kit. Affected units were distributed nationwide in the US and Canada.
Stradis Medical is recalling Henry Schein ILR Insertion Trays due to incomplete outer bag sealing that may compromise sterility. No illnesses have been reported.
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 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 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 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.
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 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 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 Industries initiated a voluntary recall of its Shoulder Arthroscopy Pack (32 kits, Lot 56865450) distributed to healthcare facilities in 23 U.S. states. The specific reason for recall is not disclosed in FDA documentation.
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 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.
DeRoyal Industries has voluntarily recalled 304 kits of the BASIC NEURO PACK (REF 89-7523.16) across 23 states. The recall is ongoing.
DeRoyal Industries initiated a voluntary recall of 6 kits of its Lumbar Disc Pack medical device distributed across 23 US states. The specific reason for recall was not detailed in the notice.
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 initiated a Class II recall of 495 endovascular tracepack kits distributed across 23 U.S. states due to an unspecified manufacturing concern.
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 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 48 kits of EYE TRAY procedure packs that contain 3M Health Care Steri Drapes which have been recalled.
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 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.
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.
Allison Medical recalls CarePoint 60 mL syringes due to green substance found on plungers. While the substance is nontoxic, its potential interaction with medications is unknown.
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.
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