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.
Cook Incorporated is recalling certain Newton Wire Guide surgical guidewires because packaging seals may be breached, potentially compromising device sterility.
Angiodynamics is recalling 40 VenaCure EVLT procedure kit units with fiber components that fail dimensional specifications. The defect may damage the sheath, necessitating removal from the patient and potential additional surgical intervention.
Leica Microsystems recalls 25 Leica Surgical Operating Microscopes (Part Number 10448999) due to a photodiode component change causing inaccurate illumination adjustment when BrightCare Plus with Luxmeter is used.
Olympus POWERSEAL electrosurgical devices are recalled for a component defect that may prevent the retention ring from securing the rotation knob, potentially delaying treatment.
bioMerieux is recalling 480 VIDAS CMV IgM test kits with invalid calibrations distributed across 18 U.S. states. The calibration errors may affect diagnostic test accuracy.
Olympus is recalling POWERSEAL 5MM electrosurgical sealers due to a component defect that may cause the rotation knob to loosen and delay surgical treatment.
Cook Incorporated is recalling Torq-Flex Wire Guide guidewires because the packaging chevron seal may be breached, potentially compromising device sterility. The affected units were distributed domestically and internationally.
Siemens Dimension Magnesium Flex reagent cartridges may produce inaccurate test results without triggering warning flags. Some results may show magnesium levels 15–59% lower than actual values.
Micro-X Rover mobile X-ray systems recalled due to a software calibration error that causes incorrect radiation dose readings. The malfunction may impede proper radiation exposure management decisions.
Cook Incorporated is recalling Movable Core Wire Guide (Tefcor) guidewires due to a packaging defect where the chevron seal may be breached, potentially compromising device sterility.
Cook Incorporated is recalling Amplatz extra Stiff Wire Guides because packaging seals may be completely breached, potentially compromising device sterility.
Cook Incorporated is recalling specific lots of Rosen Curved Wire Guide guidewires due to a complete breach of the packaging seal that may compromise device sterility. Affected devices were distributed nationwide in the US and worldwide.
Cook Incorporated is recalling fixed core wire guide devices due to packaging defects that may compromise device sterility. Approximately 5,669 units were distributed in the US and 5,286 internationally.
Petrolatum jelly products are being recalled because facility temperature excursions from June through August 2021 may have reduced product effectiveness. The FDA states this specific storage deviation is not likely to cause adverse health consequences.
Mckesson Medical-Surgical is recalling Dynarex Unna Boot Dressing products exposed to temperature excursions during June-August 2021. The manufacturer states the deviation is unlikely to cause health consequences, but products may have reduced effectiveness.
McKesson is recalling LiquiBand Exceed skin adhesive products nationwide due to facility temperature excursions between June and August 2021. The FDA states the affected products are not likely to cause adverse health consequences.
McKesson absorbent dressings manufactured by Derma Sciences are being recalled due to temperature excursions during storage from June to August 2021. The FDA states the affected dressings are not likely to cause adverse health consequences.
Cooper Surgical PREFILTER, SMOKE EVAC prefilters are recalled because they were exposed to higher temperatures during storage from June through August 2021. This exposure may have reduced the product's effectiveness.
Mckesson Medical-Surgical Inc. recalls skin markers used in medical imaging that may have been exposed to excessive temperatures during storage prior to delivery. Affected units were received between June and September 2021.
Sterilization indicator products from Mckesson Medical-Surgical distributed nationwide may have been exposed to higher temperatures between June and August 2021. The temperature excursions may have impacted product effectiveness in verifying sterilization processes.
Mckesson Medical-Surgical is recalling SPS Medical sterilization indicator strips due to temperature excursions that may have reduced their effectiveness. Products distributed June–September 2021 are affected.
MERIT MEDICAL SYSTEMS StayFIX catheter fixation devices recalled due to facility temperature excursions during storage before delivery. Approximately 109 units received between June-September 2021; manufacturer states no adverse health consequences are likely.
Mckesson is recalling SafeWash Saline Wound Flush due to temperature exposure that may have reduced product effectiveness. The recall affects units distributed nationwide from June through September 2021.
SPS Medical Supply Crosstex sterilization rolls (model SCT3) are being recalled because they were exposed to high temperatures during manufacturing facility storage before shipment. Temperature exposure may have compromised the product's sterilization effectiveness.
Mckesson is recalling Shur-Conform and ALGICELL wound care dressings due to temperature exposure affecting product effectiveness. All affected units were distributed June through September 2021.
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