FDA Medical Device Recalls (openFDA)
Beaver Visitec: 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. .
- Recall number
- Z-1088-2019
- Recalling firm
- Beaver Visitec
- Product
- 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. .
- Status
- Terminated
- Initiated
- 2019-02-19
- Posted
- not on file
- Terminated
- 2020-07-21
- 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.
- Root cause
- Error in labeling
- Action
- The firm, Beaver-Visitec International, Inc, sent an "URGENT: MEDICAL DEVICE RECALL" notification letter dated 2/19/19 to customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: 1. Immediately examine your inventory and quarantine product from this lot subject to recall. If you have further distributed this product, please identify your customers and notify them of this product recall. Consider all potential users of this product in your user supply chain. 2. Complete and return the enclosed Product Recall Notice Response & Return Form IMMEDIATELY, even if you do not have product to return via Fax 866-906-4304 or email a copy to ClaimsUS@bvimedical.com. Please include a copy of the completed Response & Return Form with your shipment in the address provided below. 3. Return All quarantined product from the affected lot to our company utilizing the Return Merchandise Authorization sticker label return (Figure 2) that is included in this letter. You may use the prepaid BVI Fed Ex number for your return. Return Merchandise--Beaver- Visitec International, Inc. Attn: QIC Team- SF74660-0001522; 3550 Roy Orr Blvd. Ste. 180 Grand Prairie, TX 75050. Please use BVI FedEx account 122227600 when shipping the returns back to Grand Prairie. If you have any specific product replacement questions you may contact our Customer Service Team at: ClaimsUS@bvimedical.com or call 866-906-8080 from 8 A.M. to 6 P.M. EST (Monday-Friday).
- Quantity
- 97 boxes (10units/box)
- 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.
- Lot, serial or model codes
- Lot Number 180615
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HNN
- Firm FEI
- 1211998
- Firm city
- Waltham
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28