Medical Device Recalls
RSS ↗7,959 medical device recalls from federal enforcement feeds.
Showing 2,951–3,000 of 7,959
- Class II
Medical Device Recall · June 18, 2025
Olympus Corporation of the Americas
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 wDiscrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
- Class II
Medical Device Recall · June 18, 2025
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: A31951Foley 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.
- Class II
Medical Device Recall · June 18, 2025
Olympus Corporation of the Americas
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.Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
- Class II
Medical Device Recall · June 18, 2025
Stryker, StrykeFlow , REF: 0250070500, 2, Disposable Suction/Irrigator without Disposable TipDue to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction.
- Class II
Medical Device Recall · June 18, 2025
Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt Crome application, Software Model Number D00U005; 2. Claria Amplia Compia appIn prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a therapy, thereby limiting the user's ability to cancel a high voltage therapy delivery.
- Class II
Medical Device Recall · June 18, 2025
Olympus Corporation of the Americas
Tubing for Male Connector 194, Ellik Evacuator. Model Number: 190-4. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
- Class II
Medical Device Recall · June 18, 2025
Brand Name: Osteotec Product Name: Osteotec Silicone Finger Implant Model/Catalog Number: OSTF-3 (Sz. 3), OSTF-4 (Sz. 4), OSTF-5 (Sz. 5) Software Version: N/A Product Description: The Osteotec SilThere is the potential that the silicone implant may contain foreign material
- Class II
Medical Device Recall · June 18, 2025
Olympus Corporation of the Americas
Cone with Male Tubing, Non-Locking, Ellik Evacuator. Model Number: 191-NRS. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
- Class II
Medical Device Recall · June 18, 2025
Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalographNatus received two complaints of left side labeling show impedance for right side.
- Class II
Medical Device Recall · June 18, 2025
Olympus Corporation of the Americas
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.Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
- Class II
Medical Device Recall · June 17, 2025
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. PerceA 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.
- Class II
Medical Device Recall · June 17, 2025
KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805LAffected 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.
- Class I
Medical Device Recall · June 17, 2025
i-view video laryngoscope. Model Number: 8008000. The i-view video laryngoscope is indicated to facilitate laryngoscopy.Potential for faulty devices as a result of depleted batteries.
- Class II
Medical Device Recall · June 17, 2025
QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SCDipstick strep A test has potential for false positive results.
- Class II
Medical Device Recall · June 17, 2025
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 professiDue to an incorrect test results provided that indicated the incorrect drug therapy recommendation
- Class II
Medical Device Recall · June 17, 2025
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; 2A 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.
- Class I
Medical Device Recall · June 16, 2025
HME TwinStar HEPA Plus Filter. Bidirectionally breathing system filter.Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
- Class II
Medical Device Recall · June 16, 2025
Biofinity XR Toric Contact LensLens blisters may have an incomplete or leaking seal which may render them unsterile.
- Class I
Medical Device Recall · June 16, 2025
SafeStar 55 Plus Filter. Bidirectionally breathing system filter.Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
- Class II
Medical Device Recall · June 16, 2025
Biofinity Toric Multifocal Contact LensLens blisters may have an incomplete or leaking seal which may render them unsterile.
- Class II
Medical Device Recall · June 16, 2025
MEDLINE INDUSTRIES, LP - Northfield
SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE010301SwabFlush 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.
- Class II
Medical Device Recall · June 16, 2025
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: 51Closed 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.
- Class I
Medical Device Recall · June 16, 2025
SafeStar 90 Plus Filter. Bidirectionally breathing system filter.Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
- Class II
Medical Device Recall · June 16, 2025
InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users)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.
- Class I
Medical Device Recall · June 16, 2025
SafeStar 60A Plus Filter. Bidirectionally breathing system filter.Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
- Class II
Medical Device Recall · June 13, 2025
Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P; PV.014P RX, REF: 014R; and PV.018, REF: 86700, 86700J used with Instructions for use.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"
- Class II
Medical Device Recall · June 12, 2025
Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement of estrone in human serum and plasma.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.
- Class II
Medical Device Recall · June 12, 2025
Estrone RIA Catalog Number DSL8700 UDI Code: 15099590211615 Estrone RIA is an in vitro diagnostic manual medical device used by healthcare professionals for the quantitative measurement of estroneEstrone 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.
- Class II
Medical Device Recall · June 12, 2025
Johnson & Johnson Vision Care, Inc.
ACUVUE¿ OASYS MAX 1-Day MULTIFOCALDue to defects (bubbles/voids) identified during standard finished goods testing
- Class II
Medical Device Recall · June 12, 2025
Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 Model/Catalog Number: 952-28-40E Software Version: NA Product Description: The EMPOWR DuaDue to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued discovered via a customer complaint.
- Class II
Medical Device Recall · June 12, 2025
Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD42 Model/Catalog Number: 952-28-42F Software Version: NA Product Description: The EMPOWR DuaDue to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued discovered via a customer complaint.
- Class II
Medical Device Recall · June 12, 2025
MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: 1) BLOOD CULTURE KIT, REF DYNDH1462B; 2) BLOOD CULTURE KIT, REF DYNDH1622C; 3) BLOOD CULTR KT DIVRSN DEVICAffected 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.
- Class II
Medical Device Recall · June 12, 2025
MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: IV START KIT LAB DRAW-SH, REF CDS860014PAffected 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.
- Class II
Medical Device Recall · June 12, 2025
MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: C-SECTION PREP, REF DYNJ32702BAffected 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.
- Class II
Medical Device Recall · June 12, 2025
Ortho-Clinical Diagnostics, Inc.
VITROS Chemistry Products OP Reagent Gen 15. Model Number: 680 1997. The VITROS OP Reagent is a dual-chambered package containing ready-to-use liquid reagents that are used to detect opiates in urine.Lots from Generation (GEN) 15 of VITROS Chemistry Products OP Reagent may generate lower than expected quality control (QC) results. If the customer is unable to get passing quality control results, then the customer would be unable to run the OP-LO protocol leading to a potential delay in patient results.
- Class II
Medical Device Recall · June 12, 2025
MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: LABOR TRIAGE KIT, REF DYKM1564Affected 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.
- Class II
Medical Device Recall · June 12, 2025
Bridge to Life EasiSlush, (Sodium Chloride Solution for Sterile Slush Preparation) (0.9% Sodium Chloride Irrigation, USP), Part Number REF BTLE-1250The 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.
- Class II
Medical Device Recall · June 11, 2025
DA VINCI PACK URO/PROSTATE. Medical convenience kit.CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
- Class II
Medical Device Recall · June 11, 2025
MAJOR THORACOSCOPY BASIN. Medical convenience kit.CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
- Class II
Medical Device Recall · June 11, 2025
PACK GENERAL ROBOTIC. Medical convenience kit.CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
- Class II
Medical Device Recall · June 11, 2025
GENERAL ROBOTIC PACK. Medical convenience kit.CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
- Class II
Medical Device Recall · June 11, 2025
PARTIAL NEPHRECTOMY PACK. Medical convenience kit.CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
- Class II
Medical Device Recall · June 11, 2025
LAVH PACK. Medical convenience kit.CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
- Class II
Medical Device Recall · June 11, 2025
GEN LAPAROSCOPY PACK. Medical convenience kit.CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
- Class II
Medical Device Recall · June 11, 2025
HVI CARDIAC ROBOT PACK. Medical convenience kit.CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
- Class II
Medical Device Recall · June 11, 2025
HSG Procedure Tray. Model Number: 6050T. The HSG Procedure Tray is for use in hysterosalpingography and sonohysterography procedures.The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, however the peel away lid labels incorrectly identify the iodine pouches as sterile.
- Class II
Medical Device Recall · June 11, 2025
DAVINCI UROLOGY. Medical convenience kit.CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
- Class II
Medical Device Recall · June 11, 2025
ROBOTIC URO/GYN PACK. Medical convenience kit.CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
- Class II
Medical Device Recall · June 11, 2025
GYN ROBOTIC PACK. Medical convenience kit.CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
- Class II
Medical Device Recall · June 11, 2025
Endosee System Convenience Kit. Model Number: ES-TRAY. Endosee System Convenience KitThe HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, however the peel away lid labels incorrectly identify the iodine pouches as sterile.