Boston Scientific Corporation recalls EXALT Model D Single- Use Duodenoscope (Box 2) UPN: M00542421 Intended Use: sterile, single-use, flexible video duodenoscope…
Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known risk of perforation and provide best clinical practices related to insertion, advancement, and removal of this device.
Read the official notice →- Date
- 2022-05-25
- Country
- United States
- Brand
- Boston Scientific
- Product
- EXALT Model D Single- Use Duodenoscope (Box 2) UPN: M00542421 Intended Use: sterile, single-use, flexible video duodenoscope intended for…
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide and the countries of Australia,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2022-08-31
USBoston Scientific Corporation recalls Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440
The impacted products were distributed with an MPXF tip curve shape instead of the 40XF tip curve shape for the Guider/40XF/8FR/90CM guide catheter.
FDA · DeviceBoston Scientific CorporationInternational distribution in the countries of Greece, France, Germany, Italy,…Official notice →- 2022-08-10
- US
Boston Scientific Corporation recalls EkoSonic Kit 106cm, 12cm TZ The EkoSonic Endovascular Device is packaged as a kit that includes both the USC and IC components.…
Product may be mislabeled.
FDA · DeviceBoston Scientific CorporationUS distribution only - CA, CT, GA, IA, IL, IN, NY, OH, TX, WYOfficial notice → - 2022-07-27
- US
Boston Scientific Corporation recalls GreenLight HPSEA Laser Fibers, UPN 0010-2092
Several complaints were received for the affected lot; users received a "Fiber type does not match card type" error message on the GreenLight XPS Laser console, necessitating the replacement of the laser fiber and…
FDA · DeviceBoston Scientific CorporationDomestic distribution to AR CA IL ME MI NC TX Foreign distribution to…Official notice → - 2022-05-04
- US
Boston Scientific Corporation recalls SpaceOAR System, UPN SO-1010, SO-2101, SO-3101, and SO-4101. Used to temporarily position the anterior rectal wall away from the…
Users need to be aware that embolism is a possible adverse event associated with hydrogel misplacements. Updated IFU provides new procedural instructions, warnings and precautions that describe steps to verify correct…
- 2022-04-20
- US
Boston Scientific Corporation recalls ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy
Pouch seals may be open, compromising sterility.
FDA · DeviceBoston Scientific CorporationDistribution in the US and territories, Japan, and CanadaOfficial notice → - 2022-03-23
- US
Boston Scientific Corporation recalls HYDRATOME RX 44-20MM/450CM Material Number: M00583060
Sterility of device is compromised due to a sterile barrier breach
FDA · DeviceBoston Scientific CorporationWorldwide distribution - US Nationwide and the countries of Australia,…Official notice →
Other drugs & medical recalls in the United States
- 2022-05-25
- US
Neuralynx Inc recalls ATLAS Stim Headbox-NK For use only with the ATLAS Neurophysiology System. CAUTION--INVESTIGATIONAL DEVICE Limited by Federal (or United…
Atlas Stim Headbox (ASHB) was delivered to US customers under a premise that the device had an Investigational Device Exemption (IDE) and was for research use only, but the manufacturer does not have an approved IDE by…
FDA · DeviceNeuralynx IncU.S. Nationwide distribution in the states of AL, CA, IL, MN, NC, RI.Official notice → - US
Total Resources Intl recalls Total Resources International First Aid Kits, Item Numbers: 01REF2621, 10OUT02086REV3. Kit contents include ULTRAtab Laboratories…
ULTRAtab Laboratories recalled Acetaminophen and electrolyte tablets that were later placed into Total Resources Intl kits. Acetaminophen and electrolyte tablets were recalled due to a Fluid Bed Drier exhaust system…
FDA · DeviceTotal Resources IntlUS: IL, PA, VA, AR, TX, IA, DE, GA, NY, LA, AL, IN, MI, MO, NC, KS, CO, AZ,…Official notice → - US
Beckman Coulter Inc. recalls MicroScan WalkAway-40 plus Instrument REF B1018-283
WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 ampere
FDA · DeviceBeckman Coulter Inc.Worldwide distribution - U.S. Nationwide distribution in the states of Alaska,…Official notice → - US
Getinge Usa Sales Inc recalls Getinge 9100-Series Washer Disinfector models: 9120E, 9125E, 9127E, 9128E, 9122EW, 9128EW.
Inadequate documentation verifying whether device installation has been executed in accordance with the manufacturer's requirements. This can lead to installation failure modes and hazardous situations.
FDA · DeviceGetinge Usa Sales IncWorldwide distribution: (US) AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KY, LA,…Official notice → - US
Atrium Medical Corporation recalls Atrium Advanta V12 Covered Stent System (OUS only). Product Code/Part Number: 85320 85321 85322 85323 85324 85325 85326 85327 85328…
Firm has observed increased rate of customer complaints related to separation of the balloon or catheter hub from the delivery catheter during delivery system withdrawal causing procedural delay and possible…
FDA · DeviceAtrium Medical CorporationForeign: Australia Austria Bahrain Belgium Bosnia-Herzegovina Brazil Bulgaria…Official notice → - US
Avanos Medical, Inc. recalls Avanos Cortrak 2 Enteral Access System (EAS)
Product labeling is being modified. STOP using the Anonymous Account Mode feature of the CORTRAK 2 device immediately. CONFIRM placement of the NG/NI tube per institution protocol.
FDA · DeviceAvanos Medical, Inc.Worldwide Distribution. US Nationwide, Australia, Austria, Canada, Germany,…Official notice →