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.
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.
ASO LLC is recalling 274,458 retail packages of three wound care products that fall apart during handling after removal from packaging, compromising their sterility and usability.
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.
Wolf-Pak Premium Dressing Kits labeled latex-free are being recalled because a component contains natural rubber latex, posing a risk to people with latex allergies.
Clearblue Smart Countdown pregnancy tests distributed to Family Dollar stores were not stored in temperature-controlled conditions. Consumers who purchased this product should return it for a refund or replacement.
Luminex Corporation recalled 257 units of the ARIES SARS-CoV-2 Assay (lot AB4042A) due to potential false negative results. The assay may fail to detect the ORF1ab gene, risking missed COVID-19 infections.
Simply Saline Nasal Mist 3.1 oz sold at Family Dollar stores has been recalled due to improper temperature storage between May and June 2022. Consumers should return the product to their local Family Dollar store.
GS Saline Solution (12 fl oz) was not stored in temperature-controlled areas, risking contamination. The affected product was sold at Family Dollar stores nationwide from May 1–June 10, 2022.
Family Dollar is recalling LIFESTYLES ULTRA SENSITIVE CONDOMS 12CT that were stored without proper temperature control. Customers should discontinue use of product purchased between May 1 and June 10, 2022.
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.
Family Dollar is recalling CURAD First Aid Kits (SKU 999037) that were improperly stored without temperature control from April 30 to June 10, 2022. The temperature exposure may have degraded medications or compromised medical devices within the kits.
Abbott Molecular is recalling the Alinity m System due to incorrect optical calibration. The affected unit (Serial Number 00654) was distributed to Italy.
Micro Therapeutics is recalling Echelon-14 Micro Catheters because outer packaging was exposed to moisture during transport. The moisture exposure could compromise the sterility or function of the device.
Family Dollar is recalling Veriquick Pregnancy Test 2CT kits (SKU 903756) sold from May 1 to June 10, 2022 due to improper storage outside temperature-controlled areas.
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.
Family Dollar's NEW SKIN Liquid Bandage was not stored in temperature-controlled conditions, potentially compromising product integrity. Affected units were sold nationwide during May through June 2022.
Family Dollar is recalling Fixodent Org Cream denture adhesive (2.4oz and 0.75oz travel sizes) sold May-June 2022 due to improper storage in non-temperature-controlled areas. No illnesses reported.
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.
Stradis Medical recalls 850 surgical forceps (NARMD MEDICAL DEPOT Forceps, part ZZ-0701) due to potentially compromised sterile barriers. Healthcare facilities with these units should identify affected lot numbers and contact the manufacturer for guidance.
Becton Dickinson recalls 9,340 units of BD PhaSeal Y-Site Connectors (Catalog 515304) due to incorrect expiration dates printed on product labels that extend beyond the actual product expiration.
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.
Trinity Sterile's IV catheter dressing trays are mislabeled as latex-free despite containing natural rubber latex in component 94-7002, risking allergic reactions in latex-sensitive users.
Family Dollar is recalling at-home marijuana test strips (SKU 900752) that were stored outside temperature-controlled areas. Improper storage may affect test accuracy.
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 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.
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