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  1. FDA Recalls
  2. ›Device Recalls

FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 3021–3040 of 39,430 recalls

Class IIOngoing

Glass Body For 194 Ellik Evacuator. Model Number: 190A. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.

Olympus Corporation of the Americas

Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).

June 18, 2025 · DeviceView details →
Class IIOngoing

Ellik Latex Bulb, Ellik Evacuator. Model Number: 194-2. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.

Olympus Corporation of the Americas

Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).

June 18, 2025 · DeviceView details →
Class IIOngoing

Ellik Evacuator Adapter, Locking. Model Number: 190-NRS. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.

Olympus Corporation of the Americas

Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).

June 18, 2025 · DeviceView details →
Class IIOngoing

Green Silicone Seal for Accessories, Reusable Silicone Seal 0 - 7 FR. Model Number: CS-G7. The reusable silicone seals fit over the biopsy port of endoscopes to seal off the working channel. Some contain a lumen which allows instruments to be passed through the seal and minimize or prevent fluid leakage during endoscopic procedures.

Olympus Corporation of the Americas

Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).

June 18, 2025 · DeviceView details →
Class IIOngoing

Bardex Lubri-Sil I.C. 400-series Temperature Sensing Silver/Hydrogel Coated All-Silicone Foley Catheter 5cc Balloon, REF: 119314; SureStep Foley Tray System Lubri-Sil I.C. Complete Care, REF: A319514A; Bard Silver Lubri-Sil Foley Tray Temperature Sensing with Bard Hydrogel and Bacti-Guard Silver Alloy Coating, 14Fr, REF: 29000J14, 29030J14, 29000J14S; Bard Silver Lubri-Sil Foley Tray Temperature Sensing, Complete Care with Bard Hydrogel and Bacti-Guard Silver Alloy Coating, 14Fr, REF: 29030J14S

C.R. Bard Inc

Foley catheter may have an obstructed lumen, which may result in an inability to drain the bladder, of urine and may include pelvic or abdominal pain, flank pain, bladder dysfunction, obstructive uropathy, acute kidney injury and/or hydronephrosis.

June 18, 2025 · DeviceView details →
Class IIOngoing

Stryker, StrykeFlow , REF: 0250070500, 2, Disposable Suction/Irrigator without Disposable Tip

Stryker Corporation

Due to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction.

June 18, 2025 · DeviceView details →
Class IIOngoing

Blue Silicone, Reusable Silicone Seal 6 - 12 FR. Model Number: CS-B612. The reusable silicone seals fit over the biopsy port of endoscopes to seal off the working channel. Some contain a lumen which allows instruments to be passed through the seal and minimize or prevent fluid leakage during endoscopic procedures.

Olympus Corporation of the Americas

Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).

June 18, 2025 · DeviceView details →
Class IIOngoing

Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Azure Astra application, Software Model Number D00U003; 2. Percepta Serena Solara application, Software Model Number D00U004; 3. Cobalt Crome application, Software Model Number D00U005; 4. Micra VR application, Software Model Number D00U006; 5. Micra AV application, Software Model Number D00U007; 6. Viva Consulta Syncra Advisa Ensura application, Software Model Number D00U008; 7. Claria Amplia Compia application, Software Model Number D00U009; 8. Evera MRI application, Software Model Number D00U010; 9. Visia AF application, Software Model Number D00U011; 10. Viva Brava Evera application, Software Model Number D00U012; 11. Micra VR2 AV2 application, Software Model Number D00U022.

Medtronic, Inc.

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.

June 17, 2025 · DeviceView details →
Class IOngoing

i-view video laryngoscope. Model Number: 8008000. The i-view video laryngoscope is indicated to facilitate laryngoscopy.

Intersurgical Inc

Potential for faulty devices as a result of depleted batteries.

June 17, 2025 · DeviceView details →
Class IIOngoing

QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SC

Quidel Corporation

Dipstick strep A test has potential for false positive results.

June 17, 2025 · DeviceView details →
Class IIOngoing

MI Cancer Seek REF MSC000 UDI Code: (01)00860008613325(21)H5HJHDSXF MI Cancer Seek is a single-site assay intended to provide tumor mutational profiling to be used by qualified healthcare professionals in accordance with professional oncology guidelines for cancer patients with previously diagnosed solid malignant neoplasms.

CARIS LIFE SCIENCES

Due to an incorrect test results provided that indicated the incorrect drug therapy recommendation

June 17, 2025 · DeviceView details →
Class IIOngoing

Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Azure Astra application, Software Model Number D00U003; 2. Percepta Serena Solara application, Software Model Number D00U004; 3. Cobalt Crome application, Software Model Number D00U005; 4. Micra VR application, Software Model Number D00U006; 5. Micra AV application, Software Model Number D00U007; 6. Viva Consulta Syncra Advisa Ensura application, Software Model Number D00U008; 7. Claria Amplia Compia application, Software Model Number D00U009; 8. Evera MRI application, Software Model Number D00U010; 9. Visia AF application, Software Model Number D00U011; 10. Viva Brava Evera application, Software Model Number D00U012; 11. Micra VR2 AV2 application, Software Model Number D00U022.

Medtronic, Inc.

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.

June 17, 2025 · DeviceView details →
Class IIOngoing

KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805L

Microbiologics Inc

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.

June 17, 2025 · DeviceView details →
Class IOngoing

SafeStar 90 Plus Filter. Bidirectionally breathing system filter.

Draeger, Inc.

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

June 16, 2025 · DeviceView details →
Class IIOngoing

Biofinity XR Toric Contact Lens

CooperVision, Inc.

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

June 16, 2025 · DeviceView details →
Class IIOngoing

InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users)

Medtronic MiniMed, Inc.

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.

June 16, 2025 · DeviceView details →
Class IOngoing

SafeStar 55 Plus Filter. Bidirectionally breathing system filter.

Draeger, Inc.

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

June 16, 2025 · DeviceView details →
Class IOngoing

SafeStar 60A Plus Filter. Bidirectionally breathing system filter.

Draeger, Inc.

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

June 16, 2025 · DeviceView details →
Class IIOngoing

BD PhaSeal Injector Luer (N30C), REF: 515001 BD PhaSeal Injector Luer Lock (N35), REF: 515003 BD PhaSeal Injector Luer Lock (N35C), REF: 515004 BD PhaSeal Injector Lu63er Lock (N35C Multi), REF: 515005 BD PhaSeal Protector (P14), REF: 515100 BD PhaSeal Protector (P21), REF: 515102 BD PhaSeal Protector (P21 Multi), REF: 515103 BD PhaSeal Protector (P28), REF: 515104 BD PhaSeal Protector (P50), REF: 515105 BD PhaSeal Protector (P50 Multi), REF: 515106 BD PhaSeal Protector (P53), REF: 515107 BD PhaSeal Protector (P55), REF: 515117 BD PhaSeal Connector Luer Lock (C35), REF: 515200 BD PhaSeal Connector Luer Lock (C45), REF: 515202 BD PhaSeal Y-site Connector (C80), REF: 515304 BD PhaSeal L Connector (C90), REF: 515305 BD PhaSeal Infusion Adapter (C100), REF: 515306 BD PhaSeal Infusion Adapter (C100 Multi), REF: 515307 BD PhaSeal Cap for Injector (M50), REF: 515404 BD PhaSeal Connector Cap (M70), REF: 515406 BD PhaSeal Optima Injector (N35-O), REF: 515052 BD PhaSeal Optima Injector (N35-O Multi), REF: 515053 BD PhaSeal Injector Locking (N40-O), REF: 515056 BD PhaSeal Injector Locking (N40-O Multi), REF: 515057 BD PhaSeal Optima Protector (P13-O), REF: 515060 BD PhaSeal Optima Protector (P13-O Multi), REF: 515062 BD PhaSeal Optima Protector (P28-O), REF: 515063 BD PhaSeal Optima Protector (P20-O), REF: 515064 BD PhaSeal Optima Protector (P20-O Multi), REF: 515065 BD PhaSeal Optima Connector (C35-O), REF: 515070 BD PhaSeal Optima Infusion Adapter (C100-O), 515078 BD PhaSeal Optima Infusion Adapter (C100-O Multi), REF: 515079

BD SWITZERLAND SARL

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.

June 16, 2025 · DeviceView details →
Class IIOngoing

Biofinity Toric Multifocal Contact Lens

CooperVision, Inc.

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

June 16, 2025 · DeviceView details →
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