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.
Astora is recalling 52 units of the MiniArc Pro Single incision Sling System because the lot number on the outer carton did not match the labels inside the box.
Ameditech is recalling iCup drug screen cups because they have shown reduced reactivity. The affected units were distributed nationwide in the US and internationally to Australia.
Ethicon Endo-Surgery is recalling Harmonic ACE+ 7 Laparoscopic Shears because holes in the Tyvek packaging can compromise the sterile barrier.
Ameditech is recalling 11 Panel Drug Abuse Tests because they have shown reduced reactivity. The affected products are distributed in the US and Australia.
TZ Medical Inc. is recalling 10,180 units of SilverStat hemostasis pads because the instructions for use did not match the original FDA submission.
Ameditech is recalling ArcPoint Labs 10 Panel Dip Screen (OXY) drug tests because they have shown reduced reactivity.
Ameditech is recalling ProScreen drug panel tests because they have shown reduced reactivity. The recall covers 31,530 units distributed in the US and Australia.
Ameditech is recalling 7,482 units of CLIA RDTC 12-Panel Cup drug abuse tests because they have shown reduced reactivity. The products were distributed in the US and Australia.
Ameditech is recalling Thermo Fisher 6 Drug Cassettes because they have shown reduced reactivity. The recall affects 220 units distributed in the US and Australia.
Agfa Healthcare is recalling IMPAX CV software versions 7.8.x and 12.x because the Demographics Manager feature may generate incorrect PDF reports after physician signature.
Ameditech is recalling 160 units of DrugSmart Dip drug abuse tests because they have shown reduced reactivity. The affected products were distributed in the US and Australia.
Ameditech is recalling specific DrugSmart drug abuse test cups because they have shown reduced reactivity. The affected units were distributed in the US and Australia.
Ameditech is recalling Premier Clia Waived 12 Panel Tilt Cup drug tests because they have shown reduced reactivity.
Ameditech is recalling 2,240 units of 6 Panel Cup Body and Lid drug tests because they have shown reduced reactivity.
Ameditech is recalling DrugSmart 10 Test Cups because they have shown reduced reactivity. The affected units were distributed nationwide in the US and internationally to Australia.
Ameditech is recalling 10-Panel Pipette Drug Screen tests because they have shown reduced reactivity. The recall affects 200 units distributed in the US and Australia.
Ameditech is recalling 70 units of DrugCheck Pipette 10 Drug Tests because they have shown reduced reactivity. The affected tests were distributed in the US and Australia.
Ameditech is recalling 12-Panel Dip Drug Screens with adulterant because they have shown reduced reactivity. The affected units were distributed nationwide in the US and internationally to Australia.
Baxter is recalling HomeChoice and HomeChoice Pro APD systems due to loud operating sounds. The devices function correctly, but the noise is unacceptable to users.
Boston Scientific is recalling RotaWire Elite Guidewires and wireClip Torquer devices due to complaints of wire fracture. The devices are used with the Rotablator Rotational Atherectomy System.
Maquet is recalling Universal Frames and Adjustable Positioning Elements after two serious thromboembolic events were reported during lumbar spine surgery.
Boston Scientific is recalling RotaWire Elite Guidewires and wireClip Torquer devices because of complaints of wire fracture. The devices are used with the Rotablator Rotational Atherectomy System.
Maquet is recalling Adjustable Positioning Elements used in spine surgery after two serious thromboembolic events were reported.
Shimadzu Medical Systems is recalling 26 C-arm Tables because the C-arm may interfere with the table top under certain circumstances.
GE Healthcare is recalling 756 MRI scanners because displayed SAR values may be lower than actual head SAR, potentially exceeding safety limits during head or neck scans.
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