Z-1122-2022Class II

Olympus DISPOSABLE GRASPING FORCEPS, FG-51D

Name: Z-1122-2022 Olympus DISPOSABLE GRASPING FORCEPS, FG-51D
Creator: Olympus Corporation of the Americas
Published: 2022-03-31
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2022-03-31 / Terminated / root cause: manufacturing process

FDA source

Olympus Corporation of the Americas began a recall of Olympus DISPOSABLE GRASPING FORCEPS, FG-51D on 2022-03-31. FDA classified it as Class II and gives the reason as "Forceps do not comply with Olympus standards for the amount of force required to open and close the forceps". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1122-2022
Classification: Class II
Status: Terminated
Initiated: 2022-03-31
Posted: 2022-05-20
Terminated: 2024-07-25
Recalling firm: OLYMPUS Corporation of the Americas
Product: Olympus DISPOSABLE GRASPING FORCEPS, FG-51D
Product code: FBN Choledochoscope And Accessories, Flexible/Rigid
Reason for recall: Forceps do not comply with Olympus standards for the amount of force required to open and close the forceps
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Olympus issued "URGENT: MEDICAL DEVICE RECALL" letter on March 28, 2022. Letter states reason for recall, health risk and action to take: 1. Immediately assess any product you have in stock to identify FG-51D forceps with affected lot numbers listed in this communication, cease use of product and quarantine any affected product. The image below depicts the area on the label where the lot number is identified. 2. Call your Olympus customer service representative at 1-888-524-7266 option 1. Olympus will issue a Return Material Authorization to return any affected product at no charge to you. Olympus will issue a credit to your facility for your affected product. 3. Access the Olympus recall portal to indicate that you have received this notification. Go to https://olympusamerica.com/recall. Enter the recall number 0407 and provide your contact information as indicated in the portal. 4. If you have distributed these devices outside your facility, please notify your customers of this corrective action immediately. Your notification to your customers may be enhanced by including a copy of this recall notification letter. Please do not hesitate to contact your Corrective Actions Lead, Americas directly at 647-999-3203 or at [email protected].
Quantity in commerce: 1386 units
Distribution: US Nationwide Distribution
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1122-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1122-2022	Class II	Terminated	Voluntary: Firm initiated	2022-06-01	2022-05-20

Product code FBN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)