November 5, 2025Medical DevicesFDA
Cepheid recalls Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Xpert SA Nasal Complete kit; 10 tes
Hazard: As a result of Post-Market half-time stability testing, false negative test result was observed for a positive sample type.
November 5, 2025Medical DevicesFDA
Trividia Health, Inc. recalls Good Neighbor Pharmacy, TRUE METRIX Self Monitoring Blood Glucose Meter. Model/Catalog Number: RE4011-01.
Hazard: 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.
November 5, 2025Medical DevicesFDA
Beckman Coulter, Inc. recalls CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions for Use (IFU
Hazard: 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.
November 5, 2025Medical DevicesFDA
MicroSurgical Technology Inc recalls MST ArcDUO 9mm, REF: ARC-0002, single-use, sterile ophthalmic knife, used with Suction Set, Part: 48-1000-01
Hazard: 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
November 5, 2025Medical DevicesFDA
Medistim Asa recalls Brand Name: Medistim MiraQ System Product Name: Medistim MiraQ System Model/Catalog Number: MQC04001, MQC14001, MQU140
Hazard: 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.
November 5, 2025Medical DevicesFDA
Vantive US Healthcare LLC recalls Sharesource Connectivity Platform for Use with Homechoice Claria Product Code 5CGM01 software versions 7.13.3 (China
Hazard: 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.
November 5, 2025Medical DevicesFDA
Greiner Bio-One North America, Inc. recalls Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322
Hazard: 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.
November 5, 2025Medical DevicesFDA
DAYE (ANNE'S DAY LTD) recalls Initiation 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-IBHF;
Hazard: Product lacks 510(k) clearance.
November 5, 2025Medical DevicesFDA
DAYE (ANNE'S DAY LTD) recalls Initiation 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-IBRF;
Hazard: Product lacks 510(k) clearance.
November 5, 2025Medical DevicesFDA
DAYE (ANNE'S DAY LTD) recalls Initiation 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-IBAIO;
Hazard: Product lacks 510(k) clearance.
November 5, 2025Medical DevicesFDA
DAYE (ANNE'S DAY LTD) recalls Initiation 3 Month Trial Tampon Box; Model Number: FG-TMP-MM-IB09090909;
Hazard: Product lacks 510(k) clearance.
November 5, 2025Medical DevicesFDA
DAYE (ANNE'S DAY LTD) recalls Initiation 18 Coated Super and 18 Nude Super Tampons; Model Number: FG-TMP-MM-IB00180018;
Hazard: Product lacks 510(k) clearance.
November 5, 2025Medical DevicesFDA
DAYE (ANNE'S DAY LTD) recalls Initiation 18 Coated Regular and 18 Nude Regular Tampons; Model Number: FG-TMP-MM-IB18001800;
Hazard: Product lacks 510(k) clearance.
November 5, 2025Medical DevicesFDA
DAYE (ANNE'S DAY LTD) recalls Initiation 18 Coated Regular and 18 Coated Super Tampons; Model Number: FG-TMP-MM-IB18180000;
Hazard: Product lacks 510(k) clearance.
November 5, 2025Medical DevicesFDA
DAYE (ANNE'S DAY LTD) recalls Initiation 36 Coated Super Tampons; Model Number: FG-TMP-MM-IB00360000;
Hazard: Product lacks 510(k) clearance.
November 5, 2025Medical DevicesFDA
DAYE (ANNE'S DAY LTD) recalls Initiation 36 Coated Regular Tampons; Model Number: FG-TMP-MM-IB36000000;
Hazard: Product lacks 510(k) clearance.
November 5, 2025Medical DevicesFDA
DAYE (ANNE'S DAY LTD) recalls Refill 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-REFHF;
Hazard: Product lacks 510(k) clearance.
November 5, 2025Medical DevicesFDA
DAYE (ANNE'S DAY LTD) recalls Refill 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-REFRF;
Hazard: Product lacks 510(k) clearance.
November 5, 2025Medical DevicesFDA
DAYE (ANNE'S DAY LTD) recalls Refill 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-REFAIO;
Hazard: Product lacks 510(k) clearance.
November 5, 2025Medical DevicesFDA
DAYE (ANNE'S DAY LTD) recalls Refill 3 Month Trial Tampon Box; Model Number: FG-TMP-MM-REF09090909;
Hazard: Product lacks 510(k) clearance.
November 5, 2025Medical DevicesFDA
DAYE (ANNE'S DAY LTD) recalls Refill 18 Coated Super and 18 Nude Super Tampons; Model Number: FG-TMP-MM-REF00180018;
Hazard: Product lacks 510(k) clearance.
November 5, 2025Medical DevicesFDA
DAYE (ANNE'S DAY LTD) recalls Refill 18 Coated Regular and 18 Nude Regular Tampons; Model Number: FG-TMP-MM-REF18001800;
Hazard: Product lacks 510(k) clearance.
November 5, 2025Medical DevicesFDA
DAYE (ANNE'S DAY LTD) recalls Refill 18 Coated Regular and 18 Coated Super Tampons; Model Number: FG-TMP-MM-REF18180000;
Hazard: Product lacks 510(k) clearance.
November 5, 2025Medical DevicesFDA
DAYE (ANNE'S DAY LTD) recalls Refill 36 Coated Super Tampons; Model Number: FG-TMP-MM-REF00360000;
Hazard: Product lacks 510(k) clearance.
November 5, 2025Medical DevicesFDA
DAYE (ANNE'S DAY LTD) recalls Refill 36 Coated Regular Tampons; Model Number: FG-TMP-MM-REF36000000;
Hazard: Product lacks 510(k) clearance.
November 5, 2025Medical DevicesFDA
DAYE (ANNE'S DAY LTD) recalls Heavy Flow Bundle; Model Number: FG-BNDL-PC-REFHF;
Hazard: Product lacks 510(k) clearance.
November 5, 2025Medical DevicesFDA
DAYE (ANNE'S DAY LTD) recalls Regular Flow Bundle; Model Number: FG-BNDL-PC-REFRF;
Hazard: Product lacks 510(k) clearance.
November 5, 2025Medical DevicesFDA
DAYE (ANNE'S DAY LTD) recalls All in One Bundle; Model Number: FG-BNDL-PC-REFAIO;
Hazard: Product lacks 510(k) clearance.
November 5, 2025Medical DevicesFDA
DAYE (ANNE'S DAY LTD) recalls Trial Tampon Box; Model Number: FG-TMP-REF04050504;
Hazard: Product lacks 510(k) clearance.
November 5, 2025Medical DevicesFDA
DAYE (ANNE'S DAY LTD) recalls 9 Coated Super and 9 Nude Super Tampons; Model Number: FG-TMP-REF00090009;
Hazard: Product lacks 510(k) clearance.