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.
Zimmer GmbH is recalling CBS micro, countersink, cannulated, AO screws (Item Number ST503004541) because they may have been manufactured from a different material than specified.
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 shortened from 9 months to 105 days.
Remel Inc is recalling 27 units of Thio Med w/o Ind, w/Dex due to potential failure in performance testing after 106 days.
Zimmer GmbH is recalling Stryker 2.7mm screw drills because they may be made from a different material than specified.
Zimmer GmbH is recalling V-TEK Micro-countersink items because they may be made from the wrong material. The products were distributed to 39 US states.
Zimmer GmbH is recalling specific cannulated drills because they may have been manufactured from a material different from the defined specifications.
Thommen Medical AG is recalling 15 units of dental adapters for handpieces because the coupling may deform, making removal difficult.
Zimmer GmbH is recalling specific cannulated drills because an investigation found they may be made 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 defined in specifications.
Zimmer GmbH is recalling contra-angle drills that may have been manufactured from a different material than specified. The products were distributed to 41 US states.
CooperSurgical is recalling 480 ICSI Micropipettes because the required thirty-degree bend is absent. The affected units were distributed in Denmark, Italy, and Sweden.
Remel Inc is recalling Thio Med w/Dex, Hemin, Vit K media because the products may fail performance testing after 57 days.
Boston Scientific is recalling two Auriga 30 laser systems because a mechanical cooling issue may cause faster-than-normal power degradation and a low power error.
Zimmer GmbH is recalling specific cannulated drills that may have been manufactured from a material different from the defined specifications.
Zimmer GmbH is recalling Stryker 26mm drills because an investigation found they may have been manufactured from a different material than specified.
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.
Remel Inc is recalling Thio Med culture media due to potential failure to meet performance standards after 106 days from manufacturing.
Zimmer GmbH is recalling Stryker 26mm drills because an investigation found they may have been manufactured from a different material than specified.
Zimmer GmbH is recalling specific 2.7mm AO surgical drills because they may have been manufactured from a material different from the specifications.
Boston Scientific is recalling six Auriga XL 4007 laser systems worldwide due to a mechanical cooling issue that may cause power degradation and stop laser emission.
Zimmer GmbH is recalling V-TEK Micro-countersink items because 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 applicable specifications.
Zimmer GmbH is recalling V-TEK IVP step drills because 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 defined specifications.
Remel Inc is recalling Thio Med w/Dex, Hem, Vit K media because it may fail performance testing after 106 days. The expiration date is being shortened from 9 months to 105 days.
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