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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.
Leica Provido surgical microscope systems may experience unexpected shutdown due to power supply overheating. Affected units should be identified by serial number and serviced immediately.
NuVasive is recalling the MAGEC 2 Rod spinal bracing system due to potential failure of the sterile packaging barrier, which could compromise device sterility.
Stradis Healthcare is recalling oral surgery trays due to incomplete outer bag sealing that may compromise the sterility of the surgical kit.
Stradis Medical is recalling the BASIC IMPLANT PACK (Item 40310SBI) due to incomplete outer bag sealing that may compromise sterility. 80 units were distributed nationwide and in Canada.
DeRoyal Industries has recalled 480 units of its BIOPSY PACK (REF 89-9614.07) in a voluntary, firm-initiated recall affecting 23 US states. The specific reason for the recall has not been disclosed.
DeRoyal has voluntarily recalled 69 kits of CNRV Spinal Pack medical devices distributed to 23 US states. The manufacturer initiated the recall on November 3, 2022.
DeRoyal Industries voluntarily initiated a Class II recall of 170 GEO-MED local anesthesia packs distributed across 23 US states. The specific safety concern is not detailed in the recall notice.
Stradis Medical recalls Henry Schein procedure trays because the outer bag may be incompletely sealed, risking sterility breach. The trays were distributed nationwide and in Canada.
DeRoyal procedure packs containing defective 3M Steri Drapes have been recalled and distributed across the United States.
Stradis Medical recalls Henry Schein temp stimulator supplies due to incomplete outer bag sealing that may compromise kit sterility. Affected units should not be used until reviewed.
Stradis Healthcare is recalling Ablation Pack Item No. 682-130 due to incomplete outer bag seals that may compromise sterility. The defect may allow contamination of surgical kits.
HENRY SCHEIN Knee Packs are being recalled due to incomplete outer bag sealing that may breach sterility. Affected surgical kits were distributed in the US and Canada.
Stradis Medical recalls 675 Henry Schein Universal Trays due to incomplete outer bag sealing that may compromise sterility. The defect affects surgical procedures nationwide and in Canada.
DeRoyal Industries voluntarily recalled 100 kits of its laminectomy spinal fusion pack after identifying a device defect. The recall affects medical facilities in 23 states.
Stradis Medical recalled Henry Schein Basic Pack medical and surgical procedure trays due to manufacturing defects causing incomplete outer bag seals that may compromise sterility. The affected kits were distributed nationwide in the US and Canada.
DeRoyal Industries recalled 48 kits of the TOTAL KNEE PACK surgical product in November 2022. The specific reason for the recall was not disclosed in the public notice.
Siemens linear accelerator systems may allow users to select the wrong treatment site, potentially delivering radiation to the wrong location. The FDA classified this Class II recall affecting 8 units across seven U.S. states.
Stradis Medical recalls medical and surgical procedure trays and kits due to incomplete outer bag sealing that may compromise sterility. Units were distributed nationwide in the US and Canada.
Stradis Medical is recalling a dental surgical pack because the outer bag may be incompletely sealed, potentially compromising sterility. Affected units should not be used.
DeRoyal Industries is recalling 68 kits of the CNRV Peripheral VAS Pack. The voluntary Class II recall affects healthcare facilities in 23 US states with specific lot numbers.
Stradis Healthcare is recalling 162 surgical implant trays distributed nationwide due to incomplete outer bag seals that may compromise sterility.
Stradis Healthcare is recalling 1-inch safety pins due to manufacturing defects that may result in incomplete sealing of outer bags, potentially compromising the sterility of medical and surgical procedure kits.
Stradis Medical is recalling catheter angiography procedure kits with potentially incompletely sealed outer bags that may compromise the sterile integrity of the medical devices.
Henry Schein Blue Tail Custom Pack surgical procedure trays are being recalled because manufacturing issues may have caused incomplete sealing of the outer bag, potentially compromising sterility.
Stradis Medical recalled 20 oral surgery implant packs with incomplete outer bag sealing that may compromise sterility. Affected lot numbers are 22228490663 and 22242491516, distributed in the US and Canada. No illnesses reported.
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