What the US Food and Drug Administration has cleared, approved and recalled on this topic, and the side effects people report.
Each number has its full source under its own list below.
90 recalls (since 1 Jan 2023). Recalls of medical devices for this topic, newest first.
Reason: Subrecall of a kitted device from SafeGuard Medical due to internal testing identified an issue affecting the device's sterile pad, potentially causing the sterile pad to degrade over time. The degra…
Reason: The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. C…
Reason: Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected product may exhibit an open or incomplete seal on the packaging of the applicator. Use of po…
Reason: The software controlling the wound imaging device's battery charging circuit was not designed to recognize and recover a battery that has fully discharged into a low-power "shipping mode." When this…
Reason: Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthal…
Reason: Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthal…
Reason: The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to th…
Reason: Surgical dressing manufactured out of specification (greater thickness).
Reason: Sterile wound dressing, lacks sterility assurance
Reason: During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances…
Source: openFDA, Medical device recalls, since 1 Jan 2023. Retrieved 12 Nov 2026.
75 devices cleared (since 1 Jan 2023). Devices the FDA cleared to sell in the US, newest first.
Company: Coloplast Corp.
Company: MLM Biologics, Inc.
Company: VacHeal, LLC
Company: Huizhou Foryou Medical Devices Co., Ltd.
Company: Beijing Kreate Medical Co., Ltd.
Company: HCS Innovation, LLC
Company: Ventris Medical
Company: Sonoma Pharmaceuticals, Inc.
Company: Silverceuticals, Inc.
Company: Convatec Limited, Gdc Building
Source: openFDA, Premarket notifications (510(k)) cleared, since 1 Jan 2023. Retrieved 12 Nov 2026.
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