Lucid Diagnostics, Inc. recalls Brand Name: EsophaCap Product Name: EsophaCap (25mm diameter, 10 pores/inch) Model/Catalog Number: EC25T10VI Software Version: N/A…
The EsophaCap sponge may be at increased risk of detaching from the string during removal of the device from the patient, particularly at the lower esophageal sphincter at the gastroesophageal junction or the upper…
Read the official notice →- Date
- 2024-06-05
- Country
- United States
- Brand
- Lucid Diagnostics, Inc.
- Product
- Brand Name: EsophaCap Product Name: EsophaCap (25mm diameter, 10 pores/inch) Model/Catalog Number: EC25T10VI Software Version: N/A Product…
- Classification
- Class II
- Units
- US Nationwide distribution in the states of MN, MD.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2024-06-05
USStryker Orthopaedics recalls Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1…
Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako System shutdown or a Mako…
FDA · DeviceStryker OrthopaedicsWorldwide - US Nationwide and the countries of Australia, Austria, Belgium,…Official notice →- US
Stryker Neurovascular recalls Trevo ProVue, Catalog: 90184
Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable…
FDA · DeviceStryker NeurovascularWorldwide - US Nationwide distribution including in the states of MN, PA, IL,…Official notice → - US
Smith & Nephew Inc recalls smith&nephew OXINIUM Femoral Head 12/14 Taper, REF 71343204, 32 MM OD +4, Sterile; and smith&nephew, 12/14 Taper, REF 71343604, 36 MM M / +4
Packaging contained the incorrect size of femoral head from what was displayed on the label.
FDA · DeviceSmith & Nephew IncInternational distribution to the countries of Australia, Germany, Japan,…Official notice → - US
FUJIFILM Healthcare Americas Corporation recalls FDR Visionary Suite - Intended to generate digital or conventional radiographic images of the skull, spinal column,…
Bolts on the CH-200 tube may rupture due to fatigue failure, causing the tube support to fall, could result in patient injury
FDA · DeviceFUJIFILM Healthcare Americas CorporationUS Nationwide distribution in the states of AK, CA, FL, IL, NE, NH, OH, TN, WI.Official notice → - US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Allura Xper FD10 system with an ADN7NT patient table. Model Number: 722010, Software Version Number 8.1.100.
When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does not engage. This issue may cause unexpected movements of the table.
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Domestic: OK International: India, Spain, U.A.E.Official notice → - US
Mirion Technologies (Capintec), Inc. recalls Captus 4000e Thyroid Uptake System. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe tests.
Complaints of unexpected detachment of the collimator have been reported.
FDA · DeviceMirion Technologies (Capintec), Inc.Worldwide - US Nationwide distribution and the countries of ALGERIA,…Official notice →