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Showing 961–980 of 22584 results

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i-view Video Laryngoscope (Intersurgical) – Battery Depletion (2025)

Potential for faulty devices as a result of depleted batteries.

FDAJun 17, 2025AZ, CA, FL +14 more• Intersurgical Inc

QuickVue Strep A Test (Quidel) – False Positive Risk (2025)

Dipstick strep A test has potential for false positive results.

FDAJun 17, 2025Nationwide• Quidel Corporation

Medtronic SmartLink Software (Medtronic) – Display Error Update (2025)

A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. The update eliminates the potential display of an erroneous electrical reset (pop-up) message upon interrogation with a SmartSync Device Manager. The erroneous message indicates an electrical reset has occurred. However, no reset has actually occurred and there are no parameter changes or loss of diagnostics. Prior to this software update, if an erroneous SmartSync message was displayed, confusion regarding the message could have caused a clinician to consider an unnecessary system revision. Medtronic has received 39 reports of this display error with two instances of unnecessary device explant through 30 April 2025.

Moderate

FDAJun 17, 2025Nationwide• Medtronic, Inc.

KWIK-STIK and LYFO DISK (Microbiologics) – Culture Media Mismatch (2025)

Affected products contain Staphylococcus epidermidis instead of the expected Brevundimonas diminuta. This may cause the user's quality control to fail and delayed diagnosis for the patient.

FDAJun 17, 2025OH, UT• Microbiologics Inc

SwabFlush Prefilled Syringe (Medline) – SwabCap Seal Issue (2025)

SwabFlush syringes are affected by the ICU Medical recall of their SwabCap Disinfecting Cap due to a manufacturing issue which affects the seal between the foil lid and plastic container of the Swab Cap. The issue may result in a reduced level of disinfection of the luer access valve, potentially resulting in patient infection/sepsis.

FDAJun 16, 2025Nationwide• MEDLINE INDUSTRIES, LP Northfield

Biofinity Toric Multifocal Lens (CooperVision) – Seal Defect (2025)

Lens blisters may have an incomplete or leaking seal which may render them unsterile.

FDAJun 16, 2025Nationwide• CooperVision, Inc.

SafeStar 60A Plus Filter (Draeger) – CO2 Sampling Issue (2025)

Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.

FDAJun 16, 2025Nationwide• Draeger, Inc.

SafeStar 55 Plus Filter (Draeger) – CO2 Sampling Issue (2025)

Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.

FDAJun 16, 2025Nationwide• Draeger, Inc.

BD PhaSeal Injector (Unknown) – Instructions Omission (2025)

Closed system drug transfer devices were shipped to the U.S. market without a U.S. version of the instructions for use, which could be an issue if a healthcare professional is prompted to review it.

FDAJun 16, 2025Nationwide

Biofinity XR Toric Contact Lens (CooperVision) – Seal Defect (2025)

Lens blisters may have an incomplete or leaking seal which may render them unsterile.

FDAJun 16, 2025Nationwide• CooperVision, Inc.

HME TwinStar HEPA Plus Filter (Draeger) – CO2 Sampling Issue (2025)

Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.

FDAJun 16, 2025Nationwide• Draeger, Inc.

SafeStar 90 Plus Filter (Draeger) – CO2 Sampling Issue (2025)

Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.

FDAJun 16, 2025Nationwide• Draeger, Inc.

InPen App (Medtronic) – Insulin Dosing Error (2025)

Medtronic MiniMed, Inc. is recalling InPen App for iOS and Android users due to software design errors that could lead to a missed short-acting insulin dose reminder and a recommendation to correct a high glucose value. It does not impact insulin delivery, long-acting insulin dose reminders, or CGM alerts, and users can still use the pen itself to calculate a dose, deliver insulin, record the dose date/time, and view CGM data. This issue was identified during internal testing before release in the US but after release to OUS customers, no complaints or MDRs related to this recall have been reported. Use of the affected device may result hyperglycemia by failing to alert the user and delay treatment of diabetes.

FDAJun 16, 2025GA• Medtronic MiniMed, Inc.

Volcano Visions IVUS Catheter (Volcano) – Entanglement Risk (2025)

Reports of IVUS catheter and guide wire entanglement during radial-to-peripheral procedures, due to catheter use without appropriate sheath and/or guide catheter, which may require further intervention, such as surgical removal; Firm is restating instructions for use and adding: "Use a guide sheath of appropriate length to provide adequate support to the rapid exchange IVUS catheter and guidewire"

FDAJun 13, 2025Nationwide• Volcano Corp

EasiSlush Solution (Bridge to Life) – Audit Timing Issue (2025)

The firm issued a field safety notice after becoming aware of three lots of products not having quarterly dose audits being completed on time in the first quarter of 2024. Routine lot by lot testing was completed properly however the quarterly dose audit (sampling/testing to monitor the gamma sterilization process and confirm the validated parameters remain effective to assure sterility and bioburden reduction per requirements) was not completed on time.

FDAJun 12, 2025Nationwide• Bridge to Life Ltd

Acuvue Oasys Max Multifocal (Johnson & Johnson) – Lens Defect (2025)

Due to defects (bubbles/voids) identified during standard finished goods testing

FDAJun 12, 2025Nationwide• Johnson & Johnson Vision Care, Inc.

Estrone RIA (Immunotech) – Result Accuracy Concern (2025)

Estrone RIA kit lots may rarely give falsely high patient results which might cause Temporary injury of Remote probability or rarely give falsely low patient results which might cause Permanent injury of Remote probability. Only in some (very rare) cases may the issue occur.

FDAJun 12, 2025Nationwide• Immunotech A.S. Radiova 1 Prague

Medline Convenience Kits (Medline) – BD ChloraPrep Seal Issue (2025)

Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by BD due to potential to exhibit an open seal on its packaging. This may constitute a breach to sterility, which may in turn lead to the infection related harms for the patient.

FDAJun 12, 2025CA, FL, PA +1 more• MEDLINE INDUSTRIES, LP Northfield

EMPOWR Acetabular (Unknown) – Packaging Discrepancy (2025)

Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued discovered via a customer complaint.

FDAJun 12, 2025AL, CA, FL +11 more

Estrone RIA (Beckman Coulter) – BSA Lot Variation (2025)

A specific lot of bovine serum albumin (BSA) used for manufacturing of coated tubes (CT) that are included in the Estrone RIA kit lots caused different affinity of manufactured coated tubes to patient samples, causing falsely increased assay results for the impacted Estrone RIA kits.

FDAJun 12, 2025NC• Beckman Coulter Inc.

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