Summary
The FDA issued a Class II for Olympus DISPOSABLE GRASPING FORCEPS, FG-51D by Olympus Corporation of the Americas. Reason: Forceps do not comply with Olympus standards for the amount of force required to open and close the forceps.
Details
Source
Device Recall
External ID
Z-1122-2022
Action Date
2022-06-01
Status
Terminated
Category
device
Product Description
Olympus DISPOSABLE GRASPING FORCEPS, FG-51D
Lot/Code Info: Lot numbers since January 2017. Affected Lot Numbers: 01K 02K 03K 04K 05K 06K 07K 08K 09K 0XK 0YK 0ZK 11H 11K 12K 13K 14K 15K 16K 17K 18K 19K 1XK 71K 72K 73K 74K 75K 76K 77H 77K 78K 79K 7XK 7YK 7ZK 81K 82K 83K 84K 85K 86K 87K 88K 89K 8XK 8YK 8ZK 91K 92K 93K 94K 95K 96K 97K 98K 99K 9XK 9YK 9ZK
Quantity Affected: 1386 units
Reason for Recall
Forceps do not comply with Olympus standards for the amount of force required to open and close the forceps
Distribution
US Nationwide Distribution
Type: Voluntary: Firm initiated
Recall Initiated: 2022-03-31
Company
Center Valley, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 139 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Olympus Corporation of the Americas has 334 FDA actions in our database, including 334 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Olympus Corporation of the Americas) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Olympus Corporation of the Americas have FDA actions?
Olympus Corporation of the Americas has 334 FDA actions in our database, including 334 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1122-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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