CLASS II ONGOING Device recall · Reported 5 Apr 2023 · FDA Enforcement Report
Instructions for Use for the following Leksell Stereotactic recalled
Elekta Instrument AB is recalling Instructions for Use for the following Leksell Stereotactic System and Leksell, distributed nationwide in the US. The recall was initiated on 1 Mar 2023 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-1309-2023
- FDA event ID
- 91780
- Recalling firm
- Elekta Instrument AB, Stockholm, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 1 Mar 2023
- FDA classified
- 30 Mar 2023
- Reported
- 5 Apr 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 1 Mar 2023 | Recall initiated by company | |
| 30 Mar 2023 | Classified by FDA | +29 days |
| 5 Apr 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The incorrect IFU was distributed with the devices.
Product as listed by the FDA
Instructions for Use for the following Leksell Stereotactic System and Leksell Neurosurgical Instruments: (1) Part #A2800-26, Backlund Catheter Insertion Needle Kit III; (2) Part #A2800-15, Backlund Catheter Insertion Needle Kit I; (3) Part #A2600-01, Backlund Haematoma Evacuator Kit; (4) Part #A2200-01, Salcman Twist Drill Kit I; (5) Part #907801, Insertion Cannula Kit; (6) Part #50398-01, Catheter Inserter Needle 1,5; (7) Part #307165, Insertion Cannula 190 MM; (8) Part #60377-02, Twist Drill 3.2 MM; (9) Part #60377-01, Twist Drill 2.1 MM; (10) Part #50376-01, Salcman Twist Drill 2.1/3.2; (11) Part #14001050, Catheter Inserter Needle 2,6; and (12) Part #1002248, Frame G w Straight/Curved Front.
Where it was distributed
US Nationwide distribution in the states of AZ, CA, CO, FL, GA, ID, IL, KS, MA, MD, MI, MN, MO, MS, NE, NH, NJ, NM, NV, NY, OH, OK, PA, SC, TN, TX, UT, WA, WI, and WV. There was also government distribution.
Nationwide ArizonaCaliforniaColoradoFloridaGeorgiaIdahoIllinoisKansasMassachusettsMarylandMichiganMinnesotaMissouriMississippiNebraskaNew HampshireNew JerseyNew MexicoNevadaNew York
Questions about this recall
Why was it recalled?
The incorrect IFU was distributed with the devices.
Which lots are affected?
UDI-DI: (1) 07340048301305; (2) 07340048300285; (3) 07340048301220; (4) 07340048301145; (5) 07340048300315; (6) 07340048308618; (7) 07340048308632; (8) 07340048308571; (9) 07340048308564; (10 07340048308601; (11) 07340048308625; and (12) 07340048306348.
Where was it sold?
US Nationwide distribution in the states of AZ, CA, CO, FL, GA, ID, IL, KS, MA, MD, MI, MN, MO, MS, NE, NH, NJ, NM, NV, NY, OH, OK, PA, SC, TN, TX, UT, WA, WI, and WV. There was also government 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 26 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 Elekta Instrument AB
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System recalled | Elekta Instrument AB | Foreign Material | 11 states |
| Device | CLASS I | Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System recalled | Elekta Instrument AB | Foreign Material | |
| Device | CLASS II | Leksell Vantage Stereotactic System recalled by Elekta Instrument AB | Elekta Instrument AB | Device Malfunction | 14 states |
| Device | CLASS II | Leksell GammaPlan recalled by Elekta Instrument AB | Elekta Instrument AB | Other | Nationwide |
Other Heart & Vascular Devices recalls
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| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |