Bolder Surgical, LLC recalls CoolSeal Generator, REF: CSL-200-50
A potential manufacturing/assembly defect could result in the generator not meeting IEC 60601 standards for medical electrical equipment, and it can potentially, under specific conditions, lead to the delivery of…
Read the official notice →- Date
- 2022-03-16
- Country
- United States
- Brand
- Bolder Surgical, LLC
- Product
- CoolSeal Generator, REF: CSL-200-50
- Classification
- Class II
- Units
- US: NY, MO, DE, PA, FL OUS: Italy, Chile, UK
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
Other drugs & medical recalls in the United States
- 2022-03-16
USCytocell Ltd. recalls Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in chromosome location from patients with AML or MDS Catalog…
individual components have been labelled with incorrect colours. The red and green colours are opposite to those specified in the product labelling. The EGR1 probe is labelled in green rather than red and the control…
FDA · DeviceCytocell Ltd.US Nationwide distribution in the states of Hawaii, Missouri, Pennsylvania,…Official notice →- US
Nextremity Solutions recalls Nextra CH Cannulated Hammertoe Mini Instrument Kit-indicated for small bone reconstruction limited to inter-digital repair and fusion of…
During insertion of the middle phalanx implant into bone, the driver may deform the implant locking mechanism and result in inadequate mating force between the middle and proximal phalanx implants, resulting in…
FDA · DeviceNextremity SolutionsUS Nationwide distribution in the states of AZ, IL, GA, LA, MD, NY, PA, TX, WA.Official notice → - US
NeuMoDx Molecular Inc recalls NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Ref # 300900 (marketed under EUA202947). Distributed in boxes of 6 assay strips in…
A risk for product contamination was identified for the affected product lot. If used, there is an increased potential for SARS-CoV-2 false positive results when using the product.
FDA · DeviceNeuMoDx Molecular IncUS Nationwide distribution in the states of FL, MD, MI, NY.Official notice → - US
Ortho-Clinical Diagnostics, Inc. recalls VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales unit is composed of 1000 tips per box.
The lot has a shape deformity which may lead to a 16% reduction in the volume of the sample or reagent dispensed. In cases where the error is not detected and the affected results are not suppressed, clinical impact…
FDA · DeviceOrtho-Clinical Diagnostics, Inc.Domestic distribution nationwide. Foreign distribution to Canada.Official notice → - US
Brainlab AG recalls ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni. 1.0.0 INST; 20910-01A, ETD Positioning and Moni. 1.0.1 INST;…
The yaw angle may be incorrect for CBCT positioning workflows using setup beams with Varian LINACs.
FDA · DeviceBrainlab AGDistribution was made to AZ, AR, CA, CO, FL, GA, IN, KY, MD, MS, MO, NJ, NY,…Official notice → - US
RAYSEARCH LABORATORIES AB recalls RayStation/RayPlan- designed for treatment planning and analysis of radiation therapy. Software Version: 6.0.0.24 , 6.1.0.26 , 6.1.1.2…
If a new primary image set is selected while the cine loop is running, the primary image set will be displayed as both primary and secondary image set in all side-by-side views. This will also be true for any new…