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.
The Anspach Effort, Inc. is recalling 297 pneumatic system attachments because the supplied directions for use did not include a recommended service interval.
The Anspach Effort, Inc. is recalling 238 units of the 14cm QD Angle Attachment because the supplied directions for use did not contain a recommended service interval.
Smith & Nephew is recalling Renovation Thin Osteotome Blades because stability data does not support the labeled 10-year shelf life.
The Anspach Effort, Inc. is recalling 32 electric handpiece controls because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 25 units of the 22CM Micro Revision Attach because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 41 units of the 19CM Attachment, Black Max because the supplied directions for use did not include a recommended service interval.
The Anspach Effort, Inc. is recalling eight Chuck Driver Systems because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 297 pneumatic tapered attachments because the supplied directions for use did not include a recommended service interval.
Breg Inc is recalling 2,609 units of Knee L/XL Dressings because some may have unsealed pouches, rendering them non-sterile.
Smith & Nephew is recalling Radial Osteotome Blades because stability data does not support the labeled 10-year shelf life.
The Anspach Effort, Inc. is recalling 16 units of the 26.65cm Attachment, Black Max because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 415 units of 8cm QD Angle Attachments because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 439 eMax2 Plus consoles because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 62 Sagittal MICRO-SAW units because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 49 units of the 5.9CM Attachment, Black Max, because the supplied directions for use did not include a recommended service interval.
The Anspach Effort, Inc. is recalling 31 Large Craniotome, Black Max units because the supplied directions for use did not include a recommended service interval.
The Anspach Effort, Inc. is recalling 3,434 eMax2 PLUS electric systems because the supplied directions for use did not include a recommended service interval.
The Anspach Effort, Inc. is recalling 14cm QD Angle Attachments because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 455 units of 11cm QD Angle Attachments because the supplied directions for use did not contain a recommended service interval.
Breg Inc is recalling approximately 2,609 sterile dressings used with cold therapy pads because some may have unsealed pouches, rendering them non-sterile.
The Anspach Effort, Inc. is recalling eight Rotating Large Craniotomes because the supplied directions for use did not include a recommended service interval.
The Anspach Effort, Inc. is recalling 17 units of the 14CM Angle Attachment, Black Max because the supplied directions for use did not contain a recommended service interval.
Sonesta Medical Ab is recalling 28 Sonesta S2 chairs because the user manual contains incorrect maximum patient weight information.
Terumo Medical Corporation is recalling Destination Renal Guiding Sheaths because the distal end may lack the labeled 5 cm of coating, potentially making device navigation difficult.
Perouse Medical is recalling 18,431 Dolphin Inflation Devices because of complaints regarding broken blisters. The devices were distributed in Arizona, Minnesota, and Tennessee.
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