CLASS II Device recall · Reported 28 Aug 2013 · FDA Enforcement Report
Gyrus Acmi recalled by Gyrus Medical
Gyrus Medical is recalling Gyrus Acmi, distributed nationwide in the US. The recall was initiated on 24 Jul 2013 and the FDA has classified it as Class II.
Check your package
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-1983-2013
- FDA event ID
- 65785
- Recalling firm
- Gyrus Medical, Osseo, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Jul 2013
- FDA classified
- 19 Aug 2013
- Reported
- 28 Aug 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 24 Jul 2013 | Recall initiated by company | |
| 19 Aug 2013 | Classified by FDA | +26 days |
| 28 Aug 2013 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
On April 29, 2013 Olympus Surgical Technologies America R&D received results from an accelerated aging study conducted as part of a new market submission. The study found that one of 60 Dissector units that underwent 3 year accelerated aging failed the dye penetration test indicating that the seal on sterile packaging was compromised. The dissector products are labeled with a 3 year shelf life.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
GYRUS ACMI, REF 3740, Everest BiCOAG Bipolar Dissecting Forceps 5mm/45 cm, Sterile EO. GYRUS ACMI, REF 3740PK, or REF 94201PK, PKS LYONS, Dissecting Forceps 5mm/45cm, Sterile EO. The Dissectors are sterile, single use electrosurgical devices that are indicated for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of laparoscopic and general surgical procedures.
Where it was distributed
Worldwide Distribution - USA (nationwide) including the states of AL, AZ, CA, FL, GA, IL, IN, KS,KY, MD, MA, MI, MN, MS, MO, NY, NC, OH, PA, SD, TN, TX, VA and WI., and the countries of BRAZIL, CHINA, AUSTRALIA, CHINA, GERMANY and INDIA.
Nationwide AlabamaArizonaCaliforniaFloridaGeorgiaIllinoisIndianaKansasKentuckyMassachusettsMarylandMichiganMinnesotaMissouriMississippiNorth CarolinaNew YorkOhioPennsylvaniaSouth Dakota
Questions about this recall
Is Gyrus Acmi recalled?
Yes. Gyrus Medical recalled Gyrus Acmi on 24 Jul 2013. The recall is Class II and its status is Terminated. Recall number Z-1983-2013.
Why was it recalled?
On April 29, 2013 Olympus Surgical Technologies America R&D received results from an accelerated aging study conducted as part of a new market submission. The study found that one of 60 Dissector units that underwent 3 year accelerated aging failed the dye penetration test indicating that the seal on sterile packaging was compromised. The dissector products are labeled with a 3 year shelf life.
Which lots are affected?
REF 3740 150080AC 258624MC G166568CC 381809KD 408020AE JF480565 NY492562 REF 3740PK 128971JB 226730IC 226742IC 226743IC 431894CE 431895CE G128677JB REF 94201PK 102290EB 147428AC 167021CC 198596GC 204439HC 204451HC 249022KC 278142BD 320659DD 344712FD 363953ID 373761JD 389095MD 418231BE G386412KD G461037EE JF493195
Where was it sold?
Worldwide Distribution - USA (nationwide) including the states of AL, AZ, CA, FL, GA, IL, IN, KS,KY, MD, MA, MI, MN, MS, MO, NY, NC, OH, PA, SD, TN, TX, VA and WI., and the countries of BRAZIL, CHINA, AUSTRALIA, CHINA, GERMANY and INDIA.
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.
More recalls from Gyrus Medical
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Gyrus Acmi recalled by Gyrus Medical | Gyrus Medical | Sterility | Nationwide |
| Device | CLASS II | Gyrus ACMI Falope-Ring Dilator recalled by Gyrus Medical | Gyrus Medical | Foreign Material | Nationwide |
| Device | CLASS II | Gyrus ACMI Disposable Falope-Ring Band Applicator Kits recalled | Gyrus Medical | Sterility | MN |
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| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Sterility | Nationwide |