CLASS II Device recall · Reported 1 Jun 2022 · FDA Enforcement Report

Olympus Disposable Grasping Forceps, Fg-51D recalled

Olympus Corporation of the Americas is recalling Olympus Disposable Grasping Forceps, Fg-51D, distributed nationwide in the US. The recall was initiated on 31 Mar 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 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 recalled1386 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1122-2022
FDA event ID: 90009
Recalling firm: Olympus Corporation of the Americas, Center Valley, PA
Classification: Class II
Status: Terminated
Recall initiated: 31 Mar 2022
FDA classified: 20 May 2022
Reported: 1 Jun 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

31 Mar 2022	Recall initiated by company
20 May 2022	Classified by FDA	+50 days
1 Jun 2022	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Forceps do not comply with Olympus standards for the amount of force required to open and close the forceps

Product as listed by the FDA

Olympus DISPOSABLE GRASPING FORCEPS, FG-51D

Where it was distributed

US Nationwide Distribution

Nationwide

Questions about this recall

Is Olympus Disposable Grasping Forceps, Fg-51D recalled?

Yes. Olympus Corporation of the Americas recalled Olympus Disposable Grasping Forceps, Fg-51D on 31 Mar 2022. The recall is Class II and its status is Terminated. Recall number Z-1122-2022.

Why was it recalled?

Forceps do not comply with Olympus standards for the amount of force required to open and close the forceps

Which lots are affected?

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

Where was it sold?

US Nationwide Distribution

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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