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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.
McKesson is recalling MedSource IV Start kits due to facility temperature excursions that may have compromised product effectiveness. Affected units were received between June and September 2021.
3M Grounding Safety Ring pads may have been exposed to excessive temperatures during storage, potentially compromising product effectiveness. The recall affects products distributed nationwide that were received between June and September 2021.
GE Centricity and Universal Viewer software may produce inaccurate distance and area measurements in the Global Stack viewport. The FDA issued a Class II recall affecting 1,690 devices.
McKesson Medical-Surgical is recalling MMS - IMMUNOSTICS INC colorectal cancer screening test kits due to facility temperature excursions that may have reduced product effectiveness. The recall affects lots distributed between June and September 2021.
Multiple Alcon contact lens solutions were recalled due to facility temperature excursions during storage and transit that may have reduced product effectiveness. Affected products include Clear Care and Opti Free Replenish solutions distributed nationwide between June and September 2021.
Mckesson is recalling Ethicon SURGIFLO Hemostatic Matrix Kit due to temperature excursions during storage that may have reduced product effectiveness. Affected units were distributed nationwide between June and September 2021.
Getinge is recalling Servo-air Ventilator Systems because they lack required warning markings about stability risks when stationary. A total of 102 units were distributed in the US; 13,750 units were distributed internationally.
Alere Fertility Test pregnancy test kits distributed in the US have been recalled because temperature excursions during storage may have reduced product effectiveness. All lots received between June 1 and September 30, 2021 are affected.
Mckesson Medical-Surgical is recalling ABX PENTRA Creatinine reagent due to facility temperature excursions (June-August 2021) that may have impacted product effectiveness. Affected lots were received nationwide between June 1 and September 30, 2021.
ABX Pentra Etching CP solution is recalled due to temperature excursions from June-August 2021 that may have affected product effectiveness. Affected lots were distributed June 1 - September 30, 2021.
bioMerieux recalls NUCLISENS easyMAG Magnetic Silica reagent kits due to contamination that may cause test failures or delayed results. Affected kits were distributed across 23 U.S. states.
McKesson Medical-Surgical is recalling Teleflex Arrow Central Venous Catheter Kits due to temperature excursions during storage and shipment. Exposure to higher temperatures may have reduced product effectiveness.
Mckesson Medical-Surgical is recalling MetriSponge cleaning sponges due to facility temperature excursions that may have compromised product effectiveness during storage and delivery between June and August 2021.
Nanosonics Sonex-HL ultrasound probe disinfectant is recalled due to temperature excursions during storage that may have affected product effectiveness.
McKesson recalls gynecological catheters that may have been exposed to temperatures higher than intended during storage, potentially affecting product effectiveness. Affected units were received between June and September 2021.
81 kits of LeadCare II blood lead test devices were recalled because temperature exposure during storage may have impacted product effectiveness. The affected lots were received between June and September 2021.
The Vanta Clinician Programmer Application may fail to connect with Vanta neurostimulators when a patient has multiple devices implanted. This prevents programming of pain therapy settings in patients with multiple implants.
Mckesson Medical-Surgical Inc. is recalling Dynarex Nail Polish Remover Pads due to facility temperature excursions in summer 2021 that may have reduced product effectiveness. All lots received between June 1 and September 30, 2021, nationwide are affected.
Mizuho OSI is recalling one batch of regular femoral hooks that were etched with an incorrect model designation. The recalled batch contains 13 devices distributed in the United States and Canada.
McKesson recalls hCG pregnancy test kits nationwide due to facility temperature excursions that may have compromised product effectiveness. Affected lots were received between June and September 2021.
Mckesson Medical-Surgical is recalling Dynarex cotton swabs (197 boxes) received June 1–September 30, 2021, due to temperature excursions during storage that may have reduced product effectiveness.
Multiple Strep A diagnostic test kits are being recalled due to temperature exposure during manufacturing and storage that may have compromised test accuracy. All lots received between June 1 and September 30, 2021 are affected.
McKesson is recalling Fischer Cone Biopsy Excisor Model 900-157 units because temperature excursions during storage may have compromised product effectiveness.
Merit Medical Systems Aspira Dressing and Drainage Kits recalled due to facility temperature excursions from June to August 2021. Exposure to higher temperatures may have reduced product effectiveness; no illnesses reported.
Mckesson Medical-Surgical is recalling Cooper Surgical Milex Pessary Ring products stored at elevated temperatures from June through August 2021, which may have degraded product effectiveness.
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