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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.
Stradis Healthcare is recalling surgical procedure kits for perioral surgery due to a manufacturing defect that may result in incomplete outer bag sealing. This could compromise the sterility of the kits.
Siemens IMMULITE 2000 allergen testing kits may produce falsely elevated results for mold allergen-specific IgE, potentially leading to incorrect mold allergy diagnoses.
Stradis Healthcare is recalling Endovenous Packs due to incompletely sealed outer bags that may compromise kit sterility. No illnesses have been reported.
Stradis Healthcare is recalling surgical and dental procedure kits due to manufacturing defects that may result in incomplete outer bag sealing and compromised sterility.
DeRoyal is recalling 146 surgical procedure kits containing recalled 3M Steri Drapes. The kits were distributed to medical facilities in 23 US states.
Stradis Healthcare is recalling surgical procedure trays due to potentially incomplete outer bag sealing that may compromise product sterility. Affected units were distributed nationwide in the US and Canada.
Stradis Healthcare is recalling Endo Pack surgical trays (Item 682-509) because manufacturing defects may result in incompletely sealed outer bags, potentially compromising kit sterility. Products were distributed in the US and Canada.
DeRoyal Industries voluntarily recalled 530 cataract surgical packs (Lot 57755800) classified as FDA Class II. The recall affects multiple U.S. states.
STRADIS HEALTHCARE WECKCELL EYE SPEARS surgical kits (Item 9430, 9431) are recalled due to incomplete outer bag sealing that may compromise kit sterility. Approximately 80 kits distributed in the US and Canada are affected.
Elekta's Oncentra Brachy radiation therapy planning software may experience reconstruction errors when using Catheter Bending functionality in versions 4.0 and above.
Stradis Medical recalls Henry Schein surgical procedure trays due to incomplete outer bag sealing that may compromise sterility. No injuries reported.
DeRoyal Industries is recalling 108 kits of Cannulated Hip Procedure Packs because they contain 3M Steri Drapes that have been recalled. Affected lots were distributed across 23 U.S. states.
DeRoyal Industries is recalling 102 HEART PACK procedure kits (Lot 57367401, expiration 3/1/2025) distributed across 23 U.S. states because they contain recalled 3M Health Care Steri Drapes.
STRADIS HEALTHCARE surgical procedure trays and kits are being recalled due to a manufacturing condition that may result in incomplete sealing of the outer bag, potentially compromising kit sterility.
Stradis Healthcare is recalling certain oral surgery trays because the outer packaging may be incompletely sealed, potentially compromising the sterility of the surgical instruments.
DeRoyal Industries Inc is recalling 85 kits of its TOTAL HIP PACK surgical device (Ref 89-9301.07). The reason for recall was not disclosed. The recall affects 22 US states with two specific lot numbers.
Stradis Healthcare is recalling Henry Schein labiaplasty procedure kits due to incomplete outer bag seals that could compromise sterility. The 42-unit recall affects products distributed nationwide in the US and Canada.
Stradis Medical recalls surgical trays with incomplete outer bag seals that may breach kit sterility. No illnesses or injuries reported.
Stradis Healthcare is recalling medical surgical procedure trays and kits with potentially incomplete outer bag seals that could compromise sterility. These products were distributed nationwide in the US and Canada.
DeRoyal Industries is recalling approximately 1,220 cataract procedure packs that contain recalled 3M Health Care Steri Drapes. The affected kits were distributed to healthcare facilities across 23 U.S. states.
Stradis Healthcare is recalling surgical kits because the outer bag may be incompletely sealed, potentially compromising the sterility of the product.
Stradis Healthcare is recalling surgical procedure trays and kits due to manufacturing defects that may result in incomplete sealing of the outer bag, potentially compromising sterility. Affected products were distributed nationwide in the US and Canada.
Zimmer Biomet is voluntarily recalling 284 NexGen tibial knee components due to higher revision rates when paired with specific femoral components. Patients with these implant combinations should contact their surgeon.
Stryker's Power-PRO 2 surgical cot may lower unexpectedly due to damaged cables, risking soft tissue injuries to patients. The recall affects 465 units distributed in the US and internationally.
Stradis Medical is recalling 104 units of Henry Schein ENT surgical procedure trays due to incomplete sealing of the outer bag, which may compromise the sterility of the kit.
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