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.
Remel Inc is recalling Thio Med w/Dex, Hem, Vit K media because products may fail performance testing after 106 days from manufacturing.
Zimmer GmbH is recalling Stryker 2.5x94mm Drills because an investigation found they may have been manufactured from a different material than specified.
Zimmer GmbH is recalling specific cannulated drills that may have been manufactured from a material different from the defined specifications.
Boston Scientific is recalling specific Auriga XL 4007 laser systems due to a mechanical cooling issue that may cause premature power degradation and low power errors.
Zimmer GmbH is recalling specific cannulated drills because they may have been manufactured from a material different from the specifications.
Neusoft Medical Systems is recalling two NeuViz 16 Essence CT scanners due to a software defect that may cause image loss during specific scans.
Zimmer GmbH is recalling specific cannulated orthopedic drills because an investigation found they may have been manufactured from a different material than specified.
Zimmer GmbH is recalling specific cannulated drills because an investigation found they may have been manufactured from a different material than specified.
Zimmer GmbH is recalling specific cannulated drills because they may have been manufactured from a material different from the specifications.
Remel Inc is recalling 8,615 units of Thio Med w/Dex, Hem, Vit K media due to potential performance failures starting 57 days after manufacturing.
Polymer Technology Systems is recalling certain Lipid Panel test strips because they may not fit tightly into the optical block, potentially causing incorrect test results.
Remel Inc is recalling Thio Med w/Dex, Hem, Vit K media because it may fail performance testing after 57 days. The expiration date is shortened to 56 days.
Zimmer GmbH is recalling specific cannulated orthopedic screws because they may have been manufactured from a material different from the specifications.
KaVo Dental Technologies is recalling 211 DEXIS Titanium Intraoral Sensors because incorrectly programmed calibration files may reduce image quality.
Zimmer GmbH is recalling specific cannulated orthopedic screws because an investigation found they may have been manufactured from a different material than specified.
Remel Inc is recalling 1,069 units of Thio Med w/Dex, Hem, Vit K media due to potential performance failures after 106 days.
Cook Inc. is recalling Kwart RetroInject and Salle Intraoperative Pyeloplasty Stent Sets because the instructions for use did not include a warning for stent knotting.
Boston Scientific is recalling specific Auriga 30 laser systems because a mechanical cooling issue may cause faster-than-normal power degradation and low power errors.
Zimmer GmbH is recalling V-TEK IVP step drills because they may have been manufactured from a material different from the applicable specifications.
Remel Inc is recalling Thio Med w/Dex, Hem, Vit, K media because it may fail performance testing after 57 days. The expiration date is shortened to 56 days.
Zimmer GmbH is recalling specific AO drills because they may be made from the wrong material. The products were distributed to 38 US states.
Zimmer GmbH is recalling specific AO drills because they may have been manufactured from a different material than specified.
Zimmer GmbH is recalling Drill Sys2.7 surgical instruments because they may have been manufactured from a material different from the defined specifications.
Remel Inc is recalling Thio Med w/o Ind, w/Dex media because it may fail performance testing after 106 days. The expiration date is being shortened to 105 days.
Neusoft Medical Systems is recalling six NeuViz 128 CT scanners due to a software defect that may cause image loss during specific scans.
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