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.
Resource Optimization & Innovation LLC is recalling 834 sterile lap chole kits because a light glove component can split, breaking the sterile field.
Resource Optimization & Innovation Llc is recalling 276 custom procedure trays because the included light gloves can split, breaking the sterile field.
Resource Optimization & Innovation Llc is recalling 14 kits of Regard sterile breast PK procedure trays because a light glove component can split during use, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 158 custom procedure trays because the included light gloves can split, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 430 sterile C-section kits because a light glove component may split, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 120 sterile custom procedure trays because the included light gloves can split, breaking the sterile field.
Resource Optimization & Innovation Llc is recalling 436 Regard custom procedure trays because a light glove component can split, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 350 Regard custom procedure trays because a light glove component can split, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 189 custom procedure trays because the included light gloves can split, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 18 sterile total hip procedure trays because a light glove component can split and break the sterile field.
Resource Optimization & Innovation LLC is recalling 156 Regard custom procedure trays because the included light gloves can split, breaking the sterile field.
Resource Optimization & Innovation LLC is recalling 92 sterile robotic laparoscopic procedure trays because a light glove component can split, breaking the sterile field.
Resource Optimization & Innovation Llc is recalling 1,056 sterile procedure trays because a light glove component can split and break the sterile field.
Resource Optimization & Innovation LLC is recalling 28 sterile pacemaker procedure kits because the included light gloves can split, breaking the sterile field.
Siemens is recalling Dimension Vista 500 and 1500 lab systems because ECREA test results may be falsely elevated in isolated cases.
Nonin Medical is recalling 15 units of the 8500M Handheld Pulse Oximeter because some devices may contain an incorrect pulse oximetry board lacking the integrated memory feature.
Siemens Medical Solutions is recalling 104 Syngo.x PACS systems to install software updates that address several unspecified issues.
Medtronic is recalling one SynchroMed II implantable drug infusion pump in Illinois due to a programmer error code that prevented updates.
Siemens Medical Solutions is recalling 104 units of Syngo.via picture archiving software to address several identified issues.
Baxter is recalling SIGMA Spectrum Infusion Pumps with Master Drug Library due to a software anomaly that may cause a Sharp Watchdog Timeout error.
Biomet 3i is recalling five units of LTX dental implants because a single part in the lot may not match the label due to a supplier error.
Merge Healthcare is recalling Eye Care Systems software because incompatible versions prevent the downloading or acquisition of new images.
Focus Diagnostics is recalling Legionella IFA Substrate Slides because the device was found not to be 510(k) exempt.
Focus Diagnostics is recalling Legionella IFA devices because the company discovered the product is not 510(k) exempt. The recall affects 196 units distributed to three testing laboratories.
AGFA Healthcare Corp. is recalling 308 DX-D100 Digital Radiography X-Ray Systems because the user manual did not specify where to store the Allen wrench used for manual movement.
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