Boston Scientific Corporation recalls EndoVive 20 Fr Safety PEG Push w/ENFit Kit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and…
Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leading to leading to a…
Read the official notice →- Date
- 2024-04-17
- Country
- United States
- Brand
- Boston Scientific
- Product
- EndoVive 20 Fr Safety PEG Push w/ENFit Kit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult…
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide and the country of Japan.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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.
More Boston Scientific recalls
- 2024-08-07
USBoston Scientific Corporation recalls Capio SLIM Suture Capturing Device, Box of 5, Outer Package UPN: M0068318261, Inner Package UPN: M0068318260. Capio SLIM Suture…
Some lots of Capio SLIM do not consistently catch the suture after activation possibly resulting in a prolonged procedure or additional medical intervention.
FDA · DeviceBoston Scientific CorporationDomestic: Nationwide Distribution. International: PendingOfficial notice →- 2024-07-24
- US
Boston Scientific Corporation recalls Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M00545170. The device is used in selective cannulation…
Foreign material may be present on the enclosed section of the cutting wire which may lead to inability to optimally bow the sphincterotome. This issue may lead to prolongation of procedure.
- 2024-05-22
- US
Boston Scientific Corporation recalls Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (5PKX3), REF H749085263002; cardiac catheter
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material…
FDA · DeviceBoston Scientific CorporationWorldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia…Official notice → - 2024-04-03
- US
Boston Scientific Corporation recalls OptiCross Coronary Imaging Catheter, REF H749518080120
Certain batches of Opticross 40MHz Coronary Imaging Catheters manufactured using an incorrect voltage setting, which may have resulted in decreased image brightness.
FDA · DeviceBoston Scientific CorporationInternational distribution to the country of Japan.Official notice → - US
Boston Scientific Corporation recalls Boston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140, facilitates femoral access to the vascular system
Boston Scientific is conducting a removal of specific batches of the iSLEEVETM 14F Expandable Introducer Set due to complaints associated with a hemostatic valve leak.
FDA · DeviceBoston Scientific CorporationWorldwide distribution - US Nationwide and the countries of Canada.Official notice → - US
Boston Scientific Corporation recalls Obsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0013972101010
An investigation determined that delivery of the Obsidio embolic using the aliquot technique for lower gastrointestinal bleeding embolization poses a high risk of bowel ischemia. The most serious and the most common…
Other drugs & medical recalls in the United States
- 2024-04-24
- US
Amneal Pharmaceuticals of New York, LLC recalls Vancomycin Hydrochloride for Oral Solution, USP, 250 mg per 5 mL, packaged as (a) 80 mL bottle, NDC 69238-2261-3; (b)…
Superpotent Drug: Due to overfilling of drug powder
- US
Esperion recalls NEXLIZET (bempedoic acid and ezetimibe) tablets, 180 mg/10 mg, 30-count bottle, Rx only, Manufactured for: Esperion Therapeutics, Ann…
Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint.
- 2024-04-17
- US
Intuitive Surgical, Inc. recalls Patient Cart, Part: 380601, a component of the da Vinci SP Surgical System, Model: SP1098
Surgical system may have inadequately welded top and/or bottom belts in the link 2 of the entry guide manipulator assembly/instrument arm joints, that may cause the following, 1) Top Failure: internal tissue injuries,…
FDA · DeviceIntuitive Surgical, Inc.US: VA, CA, NH, FL, NY, CO, AL, KY, MD, NC, NJ, OH, SC, SD, TN, WA, WI, WV,…Official notice → - US
Baxter Healthcare Corporation recalls Hillrom Welch Allyn Connex ProBP 3400 Digital Blood Pressure Device, marketed under the following models: a) PROBP 3400, SUREBP,…
Baxter received reports of an issue related to the construction of the power cord not meeting the insulation rating per country-specific requirements and international electrical standards.
- US
Qiagen Sciences LLC recalls EZ2 Connect MDx-IVD Designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecular…
Insufficient welding leads to the heater cable becoming brittle and present with an error: ERROR 3481 HEATER UNABLE TO REACH TEMPERATURE; the instrument may stop, and the sample being processed will be lost
FDA · DeviceQiagen Sciences LLCNationwide Foreign: AT, AU, BE, CH, CR, CZ, DE, DK, ES, FR, GB, HU, IT, JO,…Official notice → - US
Philips North America recalls PHILIPS Incisive Computed tomography X-ray system Incisive CT Software Upgrade from V4.5.1.41921 to V4.5.1.41989-Intended to produce…
Patient tabletop moved out to the home position during scan initialization, may cause operator/bystander staying by the rear of the table to collide with the moved tabletop and be injured
FDA · DevicePhilips North AmericaNationwide including Puerto Rico Foreign: Albania Argentina Australia Austria…Official notice →