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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.
Micro Therapeutics is recalling Echelon-14 microcatheters whose outer carton packaging was exposed to a wet substance during transport, posing a risk to device sterility.
Myolyn Inc. is recalling the power electronic box subassembly for the MyoCycle MC-2 because internal mounting screws may come loose during shipping, creating a risk of electrical shock.
Stradis Medical is recalling NARMD MEDICAL DEPOT Kelly Straight forceps because the sterile barrier may be compromised. The recall affects 825 units distributed nationwide in South Carolina.
Trinity Sterile's Wolf Pak Premium Dressing Change Kit is mislabeled as latex-free but contains natural rubber latex in component 94-7002. This poses a risk to people with latex allergies.
Family Dollar is recalling SKYN Original, Elite, and LS non-latex condoms due to improper storage. Products sold between May 1 and June 10, 2022 were not stored in temperature-controlled conditions.
Family Dollar is recalling BIOTRU Multi-Purpose Solution (4 oz, SKU 999009) due to improper temperature-controlled storage. Approximately 1,051 units were affected across US Family Dollar stores.
Stradis Medical is recalling NARMD MEDICAL DEPOT Iris Curved Scissors (Part Number ZZ-0697) because the sterile barrier may be compromised, potentially exposing patients to contamination during surgical procedures.
Family Dollar is recalling VeriQuick pregnancy tests that were not stored in temperature-controlled areas between April-June 2022. Improper storage conditions may affect test accuracy.
Family Dollar is recalling CURAD waterproof bandages due to improper storage outside temperature-controlled conditions. The recall affects approximately 419 units sold nationwide between May 1 and June 10, 2022.
Family Dollar is recalling DENTEMP temporary dental filling products (SKU 902139) that were stored outside temperature-controlled conditions. The product was sold at Family Dollar stores nationwide between May and June 2022.
KY Jelly Lubricant 2 FL OZ (SKU 901443) distributed at Family Dollar stores was not stored in temperature-controlled areas. Consumers should discontinue use of product purchased between May–June 2022.
Family Dollar is recalling at-home marijuana test strips (SKU 900752) that were stored outside temperature-controlled areas. Improper storage may affect test accuracy.
OPTI FREE REPLENISH contact lens solution sold at Family Dollar stores (May 1–June 10, 2022) was not stored in temperature-controlled areas and is being recalled.
Family Dollar is recalling GS Denture Cleanser tablets (green and overnight formulas) due to improper storage in non-temperature-controlled areas. Products sold May 1 - June 10, 2022 may be affected.
Family Dollar Stores is recalling Clear Eyes Contact Lens Drops Lubricating due to improper storage in non-temperature-controlled areas. The product was sold nationwide between May 1 and June 10, 2022.
Polident denture cleansers sold at Family Dollar stores nationwide are being recalled due to improper storage conditions. No illnesses or injuries have been reported.
Family Dollar Stores is recalling First Response 2 CT pregnancy tests due to improper storage outside temperature-controlled areas. Affected products were sold nationwide between May 1 and June 10, 2022.
Siemens recalls 399 units of AXIOM Sensis systems due to risk of patient electrical shock if the Signal Input Box mounting deviates from its default position.
Family Dollar Stores recalls multiple Poligrip denture adhesive products due to improper storage outside temperature-controlled areas. Affected products were sold between May 1 and June 10, 2022.
FDA recalls approximately 8.7 million viral transport containers that were distributed without regulatory clearance and without complying with FDA guidance for proper viral transport specifications.
The FDA recalled 3.95 million viral transport containers distributed without FDA clearance and in violation of established guidance. The containers were distributed worldwide, including to facilities in California, Florida, Illinois, and New York.
Medtronic's Cobalt implantable cardioverter defibrillators may deliver approximately 79% of programmed shock energy during high-voltage therapy. Patients with affected models should contact their physician.
Medtronic is recalling 1,657 Crome implantable cardioverter defibrillators due to potential reduced shock energy during high-voltage therapy. Affected devices may deliver only 79% of programmed energy.
Medtronic Cobalt implantable cardioverter defibrillators may deliver approximately 79% of programmed shock energy during high-voltage therapy. The reduced energy could affect device performance in patients requiring defibrillation.
Medtronic has recalled 8,429 Cobalt implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) worldwide due to potential reduced shock energy during therapy, potentially delivering 79% of programmed energy.
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