Medical device recalls
38684 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2025-11-05FDA-DeviceCepheidClass IIXpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Xpert SA Nasal Complete kit; 10 test kit: A collection of reagents and other associated materials intended to be used for the direct qualitative and/or quantitative detection of nucleic acid from methicillin-resistant and methicillin-susceptible Staphylococcus aureus (MRSA/MSSA) bacteria present in a clinical specimen, using a nucleic acid technique
As a result of Post-Market half-time stability testing, false negative test result was observed for a positive sample type.
- 2025-11-05FDA-DeviceTrividia Health, Inc.Class IIGood Neighbor Pharmacy, TRUE METRIX Self Monitoring Blood Glucose Meter. Model/Catalog Number: RE4011-01.
Manufacturing defect causing LCD display issues with missing or partial segments (ghosting) that can result in misreading glucose values, potentially leading to inappropriate treatment decisions for diabetes management.
- 2025-11-05FDA-DeviceBeckman Coulter, Inc.Class IICellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions for Use (IFU) revisions AD and prior. These CellMek devices include Cassette E.
Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis device instructions for use list incorrect dead volumes: Cassette Type/List volume/correct volume, B/750/1582 microliters, and E/1300/2093 microliters. Device software does not rock Cassette E, used with 15mmX92mm Sarstedt tubes. May lead to incorrect diagnosis or error in patient management/treatment.
- 2025-11-05FDA-DeviceMicroSurgical Technology IncClass IIMST ArcDUO 9mm, REF: ARC-0002, single-use, sterile ophthalmic knife, used with Suction Set, Part: 48-1000-01
An ophthalmic knife has a suction set (not direct patient-contacting), which contains springs contaminated with an unidentified residue that may potentially cause eye irritation
- 2025-11-05FDA-DeviceMedistim AsaClass IIBrand Name: Medistim MiraQ System Product Name: Medistim MiraQ System Model/Catalog Number: MQC04001, MQC14001, MQU14011, MQV12011 Software Version: Not applicable Product Description: Ultrasound device for intraoperative use Component: No
Printer Support Module (PSM) may be subject to insufficient soldering, which may cause loosening of the wires and system to shut down. Affected devices need to have their Printer Support Modules replaced.
- 2025-11-05FDA-DeviceVantive US Healthcare LLCClass IISharesource Connectivity Platform for Use with Homechoice Claria Product Code 5CGM01 software versions 7.13.3 (China), 8.13.2 (APAC and Korea), and 8.13.4 (US, EMEA, and LATAM)
Vantive has identified a software defect within the Sharesource Claria software, which may cause a patient s updated prescription program settings to not be properly saved on the actual cycler that the patient is using to perform their therapy. As a result, the clinician may think that the patient is receiving the correct prescribed therapy because of what is erroneously displayed on the clinician's remote Sharesource application, when in fact the cycler that is with the patient is actually delivering an outdated and incorrect therapy.
- 2025-11-05FDA-DeviceGreiner Bio-One North America, Inc.Class IIGreiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322
Blood collection tubes were manufactured with the label applied too high on the tube, which shifted the printed fill level mark upward, which could result in unnecessary sample rejection and repeat collections.
- 2025-11-05FDA-DeviceDAYE (ANNE'S DAY LTD)Class IIInitiation 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-IBHF;
Product lacks 510(k) clearance.
- 2025-11-05FDA-DeviceDAYE (ANNE'S DAY LTD)Class IIInitiation 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-IBRF;
Product lacks 510(k) clearance.
- 2025-11-05FDA-DeviceDAYE (ANNE'S DAY LTD)Class IIInitiation 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-IBAIO;
Product lacks 510(k) clearance.
- 2025-11-05FDA-DeviceDAYE (ANNE'S DAY LTD)Class IIInitiation 3 Month Trial Tampon Box; Model Number: FG-TMP-MM-IB09090909;
Product lacks 510(k) clearance.
- 2025-11-05FDA-DeviceDAYE (ANNE'S DAY LTD)Class IIInitiation 18 Coated Super and 18 Nude Super Tampons; Model Number: FG-TMP-MM-IB00180018;
Product lacks 510(k) clearance.
- 2025-11-05FDA-DeviceDAYE (ANNE'S DAY LTD)Class IIInitiation 18 Coated Regular and 18 Nude Regular Tampons; Model Number: FG-TMP-MM-IB18001800;
Product lacks 510(k) clearance.
- 2025-11-05FDA-DeviceDAYE (ANNE'S DAY LTD)Class IIInitiation 18 Coated Regular and 18 Coated Super Tampons; Model Number: FG-TMP-MM-IB18180000;
Product lacks 510(k) clearance.
- 2025-11-05FDA-DeviceDAYE (ANNE'S DAY LTD)Class IIInitiation 36 Coated Super Tampons; Model Number: FG-TMP-MM-IB00360000;
Product lacks 510(k) clearance.
- 2025-11-05FDA-DeviceDAYE (ANNE'S DAY LTD)Class IIInitiation 36 Coated Regular Tampons; Model Number: FG-TMP-MM-IB36000000;
Product lacks 510(k) clearance.
- 2025-11-05FDA-DeviceDAYE (ANNE'S DAY LTD)Class IIRefill 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-REFHF;
Product lacks 510(k) clearance.
- 2025-11-05FDA-DeviceDAYE (ANNE'S DAY LTD)Class IIRefill 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-REFRF;
Product lacks 510(k) clearance.
- 2025-11-05FDA-DeviceDAYE (ANNE'S DAY LTD)Class IIRefill 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-REFAIO;
Product lacks 510(k) clearance.
- 2025-11-05FDA-DeviceDAYE (ANNE'S DAY LTD)Class IIRefill 3 Month Trial Tampon Box; Model Number: FG-TMP-MM-REF09090909;
Product lacks 510(k) clearance.
- 2025-11-05FDA-DeviceDAYE (ANNE'S DAY LTD)Class IIRefill 18 Coated Super and 18 Nude Super Tampons; Model Number: FG-TMP-MM-REF00180018;
Product lacks 510(k) clearance.
- 2025-11-05FDA-DeviceDAYE (ANNE'S DAY LTD)Class IIRefill 18 Coated Regular and 18 Nude Regular Tampons; Model Number: FG-TMP-MM-REF18001800;
Product lacks 510(k) clearance.
- 2025-11-05FDA-DeviceDAYE (ANNE'S DAY LTD)Class IIRefill 18 Coated Regular and 18 Coated Super Tampons; Model Number: FG-TMP-MM-REF18180000;
Product lacks 510(k) clearance.
- 2025-11-05FDA-DeviceDAYE (ANNE'S DAY LTD)Class IIRefill 36 Coated Super Tampons; Model Number: FG-TMP-MM-REF00360000;
Product lacks 510(k) clearance.
- 2025-11-05FDA-DeviceDAYE (ANNE'S DAY LTD)Class IIRefill 36 Coated Regular Tampons; Model Number: FG-TMP-MM-REF36000000;
Product lacks 510(k) clearance.
- 2025-11-05FDA-DeviceDAYE (ANNE'S DAY LTD)Class IIHeavy Flow Bundle; Model Number: FG-BNDL-PC-REFHF;
Product lacks 510(k) clearance.
- 2025-11-05FDA-DeviceDAYE (ANNE'S DAY LTD)Class IIRegular Flow Bundle; Model Number: FG-BNDL-PC-REFRF;
Product lacks 510(k) clearance.
- 2025-11-05FDA-DeviceDAYE (ANNE'S DAY LTD)Class IIAll in One Bundle; Model Number: FG-BNDL-PC-REFAIO;
Product lacks 510(k) clearance.
- 2025-11-05FDA-DeviceDAYE (ANNE'S DAY LTD)Class IITrial Tampon Box; Model Number: FG-TMP-REF04050504;
Product lacks 510(k) clearance.
- 2025-11-05FDA-DeviceDAYE (ANNE'S DAY LTD)Class II9 Coated Super and 9 Nude Super Tampons; Model Number: FG-TMP-REF00090009;
Product lacks 510(k) clearance.
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