Waltham, MA, United States
Beaver Visitec recalls
6 recalls recorded since 2018, most recently on 12 March 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls6
Ongoing (FDA)0
Terminated or completed6
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 12 March 2019
- Terminated
- 11 August 2020
- Reason
- Mislabeled. The package labeling indicates a size 2.4mm, 45 degree Double Bevel knife however, the marking on device shows a 2.75mm size device
- Distribution
- Worldwide Distribution - US Nationwide Foreign:UNITED KINGDOM JAPAN NETHERLANDS
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1111-2019
- Beaver Xstar Slit Knife 2.4 mm, 45degree Double Bevel, Ophthalmic-utilized in Cataract and Glaucoma procedures REF # 370824 Product Usage: Ophthalmic techniques-utilized in Cataract and Glaucoma procedures
Terminated Class III Medical devices
- Recall started
- 19 February 2019
- Terminated
- 21 July 2020
- Reason
- The product contains a misprinted expiration date on the peel pack. Both were printed as "180615", which is the lot number. The Lot number is correct.
- Distribution
- US Nationwide Distribution to states of : AL, AZ, CA, FL, ID, MN, MO, NY, OH, PA, and TX; and internationally to: Ireland and UK.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1088-2019
- Micro Knife 5.0mm 30¿, Part Number 0001522 The Beaver¿ Micro Knife 5.0mm 30¿ is a sharp pointed tip intended for ophthalmic, ENT and other forms of surgery stab incisions and other microsurgical techniques. .
Terminated Class II Medical devices
- Recall started
- 30 November 2018
- Terminated
- 1 May 2020
- Reason
- Certain lots are missing a protective sheath component over the silicone tip, which may result in the silicone tip breaking or detaching at the metal tube component. If the tip becomes detached during a procedure while in the eye, the fragment will need to be retrieved to mitigate the possibility of injury.
- Distribution
- Worldwide distribution: US (nationwide) to states of: AR, AZ, CA, CO, FL, GA, LA, MD, MO, NC, NE, NJ, NY, OH, OK, TX, UT, VA, WA; and countries of: Mexico and Peru.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1066-2019
- BVI Visitec Soft Tip Cannula, 0.8MM .50 x 33mm (25G x 1.3 in). The BVI Soft Tip Cannula is intended to irrigate and/or aspirate ophthalmic solutions and liquids in or out of the eye, and remove materials where appropr
Terminated Class II Medical devices
- Recall started
- 19 July 2018
- Terminated
- 23 May 2019
- Reason
- A small number of devices in this lot may have a melted cap and a hole formed through the packaging. The risk is potentially the product will no longer be sterile for use and may cause harm to a patient.
- Distribution
- Worldwide Distribution - US Nationwide in the states of: CA, DC, FL, IA, ID, IL, MA, MI, MN, NY, OK, PA, TN, TX, UT, and WA and the countries of Australia, France, Netherlands, Spain, and United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3045-2018
- Beaver Accu-Temp High Temperature Cautery, 2 inch Shaft with Fine Tip, Model Number 8445000 Product Usage: The indications and intended use of the High Temp cautery are for coagulating tissue or arresting bleeding fro
Terminated Class II Medical devices
- Recall started
- 18 June 2018
- Terminated
- 30 October 2019
- Reason
- Mislabel of product 373726 Lot 6001700 with 374891 Lot 6001701 on individual packages within the correctly labeled shelf carton.
- Distribution
- Distribution to US states of CA, IL, MD, MN, NJ, OH & PA; and Israel
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2740-2018
- Slit Knife 2.6mm 45degree Bevel Up, Model Number 373726. for use in ophthalmic surgery.
Terminated Class II Medical devices
- Recall started
- 14 May 2018
- Terminated
- 8 June 2021
- Reason
- Blades are loose in handles and may fall out due to non cured epoxy
- Distribution
- US Nationwide in the states of CA, IA, CO, HI, IA, MD & TX
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2342-2018
- Safety Sideport Knife 1.0mm 45¿, REF 378210 Product Usage: Indicated to make stab incisions during ophthalmic surgery
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.