Boston Scientific Corporation recalls ORISE Gel Submucosal Lifting Agent--Indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps,…
***Update12/13/22***:Product removal due to higher incidence of adverse events of foreign body reactions*** Potential outcomes associated with foreign body reaction to remnant ORlSE Gel post procedure. Foreign body…
Read the official notice →- Date
- 2022-11-16
- Country
- United States
- Brand
- Boston Scientific
- Product
- ORISE Gel Submucosal Lifting Agent--Indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas,…
- Classification
- Class II
- Units
- Worldwide Distribution: US (Nationwide) and (Foreign) countries of: Algeria…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2023-05-24
USBoston Scientific Corporation recalls WATCHDOG Hemostasis Valve Kit, UPN H74939343A022 (outer package), UPN H74939343A020 (inner package)
The firm received complaints of the Insertion Tool component being occluded, resulting in the inability to pass a guidewire through the tool.
- 2023-04-26
- US
Boston Scientific Corporation recalls Habib EndoHPB Bipolar Radiofrequency (RF) Catheter 8F (2.7mm). A radiofrequency (RF) catheter which provides bipolar energy to…
Cease use of the Habib EndoHPB Bipolar RF Catheter with the ERBE VIO3 Generator immediately due to the potential for delivery of excessive energy leading to thermal injury or tissue damage. An inaccurate setting is…
FDA · DeviceBoston Scientific CorporationWorldwide distribution - US Nationwide and the countries of Argentina,…Official notice → - 2023-03-15
- US
Boston Scientific Corporation recalls LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Software Model 6460.
Under specific circumstances, the U.S. product registration system did not send up enablement requests to U.S. LATITUDE Customer Support during an 8-month interval in 2022. For these patients, the HeartLogic Index and…
FDA · DeviceBoston Scientific CorporationUS Nationwide distribution to the healthcare facilities and healthcare…Official notice → - 2022-11-09
- US
Boston Scientific Corporation recalls EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile.
There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.
FDA · DeviceBoston Scientific CorporationWorldwide distribution - US Nationwide distribution in the countries of AL,…Official notice → - US
Boston Scientific Corporation recalls EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, which is a component of the EkoSonic Endovascular System.
Consoles were shipped without an instruction for use (IFU) or with the incorrect IFU.
FDA · DeviceBoston Scientific CorporationDistribution was made to CA, IL, KY, OH, OK, RI, TX. There was no…Official notice → - 2022-09-07
- US
Boston Scientific Corporation recalls The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable…
There is potential for unanticipated software anomalies to occur when using the Model 2868 Application loaded on the 3120 ZOOM LATITUTDE programmer when communicating with certain Boston Scientific transvenous…
Other drugs & medical recalls in the United States
- 2022-11-23
- US
Par Formulations Private Limited recalls Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottles, RX only Dist. by: Par Pharmaceutical Chestnut Ridge, NY…
Failed Impurities/Degradation Specifications
- US
ImprimisRx NJ recalls Timolol-Latanoprost (0.5/0.005%) ophthalmic drops, Compounded, 5 mL bottle, Imprimis Rx, Ledgewood, NJ.
Subpotent Drug: The batches contain less than 90% of the labeled amount of latanoprost.
- US
- 2022-11-16
- US
CooperSurgical, Inc. recalls NEO-fit Neonatal Endotracheal Tube Grip, Part Number 42-2540
Firm has received 11 complaints involving a loose or detached metal clips, including 3 cases where the metal clip was ingested by the patient, and 3 cases where the metal clip was removed from the patient's mouth. In…
FDA · DeviceCooperSurgical, Inc.Worldwide distribution: US (Nationwide) including Puerto Rico; and countries…Official notice → - US
X-NAV Technologies, LLC recalls X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration. Catalog…
Product missing one of two welds connecting the tip to the shaft, if the remaining weld breaks, it is possible that the tip could fall out during X-Mark registration and fall into the patient s mouth. In this case, the…
FDA · DeviceX-NAV Technologies, LLCUS Nationwide distribution and Foreign country of: CanadaOfficial notice → - US
Ortho-Clinical Diagnostics, Inc. recalls VITROS Chemistry Products Calibrator Kit 9 -(GEN) 22 of VITROS PHYT Slides For in vitro diagnostic use only. Product Code:…
Calibration disk Data Release Version (DRV) 6194 to 6200 contain inappropriate calibration mathematics for VITROS Calibration Kit 9 for calibrating VITROS PHYT Slides, for all lots of slide generation 22 (GEN 22). The…
FDA · DeviceOrtho-Clinical Diagnostics, Inc.Worldwide Distribution: US (Nationwide) and Countries (Foreign) including:…Official notice →