Vermont recalls
3190 federal recalls on file affecting Vermont - 113 Vermont-specific plus 3077 nationwide. Sourced from CPSC, FDA, USDA, and NHTSA.
- 2025-11-06CPSCMengnaNationwideF&F Fine Wines Recalls Kirkland Signature Valdobbiadene Prosecco Entrapment or Suffocation; Violates Mandatory Standards for Mattresses; Sold on Amazon by Mengna Criblike Mattresses Recalled Due to Risk of Serious Injury or Death from Entrapment
The aftermarket mattresses violate the mandatory standard for crib mattresses, as the mattresses may not adequately fit certain play yards or non-full-sized cribs, posing a deadly entrapment hazard. Babies can suffocate in gaps between an undersized mattress, or extra padding, and side walls of a product, especially when the infant's face becomes trapped against the side and the mattress, preventing the infant from breathing. The non-full-sized crib mattress also fails to meet the mandatory standard for mattress set flammability.
- 2025-11-06CPSCPelotonNationwidePeloton Recalls Original Series Bike+ Exercise Bikes Due to Fall and Injury Hazards
The bike's seat post assembly can break during use, posing fall and injury hazards to the user.
- 2025-11-05FDA-DeviceMicrogenicsClass IINationwideThermo scientific MAS Omni CARDIO, Liquid Assayed Integrated Cardiac Control, Model/Catalog Number: OCRD-L, OCRD-101, OCRD-202, OCRD-303, OCRD-SP, OCRD-MP, OCRD-UL; Product Description: In Vitro Diagnostic external control
The firm received complaints from customers reporting vial-to-vial variability when using the control with high sensitivity Troponin I assays. This defect may lead to as delay in patient results for hs Troponin I assays.
- 2025-11-05FDA-DeviceCepheidClass IINationwideXpert 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 HealthClass IINationwideGood 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 CoulterClass IINationwideCellMek 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 TechnologyClass IINationwideMST 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-DeviceVantiveClass IINationwideSharesource 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-OneClass IINationwideGreiner 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-DeviceDayeClass IINationwideInitiation 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-IBHF;
Product lacks 510(k) clearance.
- 2025-11-05FDA-DeviceDayeClass IINationwideInitiation 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-IBRF;
Product lacks 510(k) clearance.
- 2025-11-05FDA-DeviceDayeClass IINationwideInitiation 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-IBAIO;
Product lacks 510(k) clearance.
- 2025-11-05FDA-DeviceDayeClass IINationwideInitiation 3 Month Trial Tampon Box; Model Number: FG-TMP-MM-IB09090909;
Product lacks 510(k) clearance.
- 2025-11-05FDA-DeviceDayeClass IINationwideInitiation 18 Coated Super and 18 Nude Super Tampons; Model Number: FG-TMP-MM-IB00180018;
Product lacks 510(k) clearance.
- 2025-11-05FDA-DeviceDayeClass IINationwideInitiation 18 Coated Regular and 18 Nude Regular Tampons; Model Number: FG-TMP-MM-IB18001800;
Product lacks 510(k) clearance.
- 2025-11-05FDA-DeviceDayeClass IINationwideInitiation 18 Coated Regular and 18 Coated Super Tampons; Model Number: FG-TMP-MM-IB18180000;
Product lacks 510(k) clearance.
- 2025-11-05FDA-DeviceDayeClass IINationwideInitiation 36 Coated Super Tampons; Model Number: FG-TMP-MM-IB00360000;
Product lacks 510(k) clearance.
- 2025-11-05FDA-DeviceDayeClass IINationwideInitiation 36 Coated Regular Tampons; Model Number: FG-TMP-MM-IB36000000;
Product lacks 510(k) clearance.
- 2025-11-05FDA-DeviceDayeClass IINationwideRefill 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-REFHF;
Product lacks 510(k) clearance.
- 2025-11-05FDA-DeviceDayeClass IINationwideRefill 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-REFRF;
Product lacks 510(k) clearance.
- 2025-11-05FDA-DeviceDayeClass IINationwideRefill 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-REFAIO;
Product lacks 510(k) clearance.
- 2025-11-05FDA-DeviceDayeClass IINationwideRefill 3 Month Trial Tampon Box; Model Number: FG-TMP-MM-REF09090909;
Product lacks 510(k) clearance.
- 2025-11-05FDA-DeviceDayeClass IINationwideRefill 18 Coated Super and 18 Nude Super Tampons; Model Number: FG-TMP-MM-REF00180018;
Product lacks 510(k) clearance.
- 2025-11-05FDA-DeviceDayeClass IINationwideRefill 18 Coated Regular and 18 Nude Regular Tampons; Model Number: FG-TMP-MM-REF18001800;
Product lacks 510(k) clearance.
- 2025-11-05FDA-DeviceDayeClass IINationwideRefill 18 Coated Regular and 18 Coated Super Tampons; Model Number: FG-TMP-MM-REF18180000;
Product lacks 510(k) clearance.
- 2025-11-05FDA-DeviceDayeClass IINationwideRefill 36 Coated Super Tampons; Model Number: FG-TMP-MM-REF00360000;
Product lacks 510(k) clearance.
- 2025-11-05FDA-DeviceDayeClass IINationwideRefill 36 Coated Regular Tampons; Model Number: FG-TMP-MM-REF36000000;
Product lacks 510(k) clearance.
- 2025-11-05FDA-DeviceDayeClass IINationwideHeavy Flow Bundle; Model Number: FG-BNDL-PC-REFHF;
Product lacks 510(k) clearance.
- 2025-11-05FDA-DeviceDayeClass IINationwideRegular Flow Bundle; Model Number: FG-BNDL-PC-REFRF;
Product lacks 510(k) clearance.
- 2025-11-05FDA-DeviceDayeClass IINationwideAll in One Bundle; Model Number: FG-BNDL-PC-REFAIO;
Product lacks 510(k) clearance.
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