CLASS II ONGOING Device recall · Reported 20 Nov 2024 · FDA Enforcement Report
Medtronic Recharger Kits, RS6230, RS7230, and RS5220A recalled
Medtronic Neuromodulation is recalling Medtronic Recharger Kits, RS6230, RS7230, and RS5220A, containing components WR9230 and, distributed nationwide in the US. The recall was initiated on 18 Sep 2024 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-0372-2025
- FDA event ID
- 95465
- Recalling firm
- Medtronic Neuromodulation, Minneapolis, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 18 Sep 2024
- FDA classified
- 13 Nov 2024
- Reported
- 20 Nov 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 18 Sep 2024 | Recall initiated by company | |
| 13 Nov 2024 | Classified by FDA | +56 days |
| 20 Nov 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The Wireless Rechargers in the kits may be unable to enter a recharging session upon first use.
Product as listed by the FDA
Medtronic Recharger Kits, RS6230, RS7230, and RS5220A, containing components WR9230 and WR9220A Recharger for rechargeable implantable neurostimulators. The Rechargers are used with Neurostimulator Inceptiv INS Model 977119 and Percept RC INS Model B35300 as part of the Deep Brain Stimulation (DBS) system. WR9220A is used with InterStim Micro, Model 97810, as part of Pelvic Health system
Where it was distributed
Worldwide - US Nationwide distribution in the states of AL, AZ, CA, FL, GA, ID, MD, MI, MN, MO, NC, NJ, OH, PA, SC, TX, VA, and WA. The countries of Austria, Belgium, Denmark, Finland, Germany, Ireland, Italy, Japan, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, and United Kingdom.
Nationwide AlabamaArizonaCaliforniaFloridaGeorgiaIdahoMarylandMichiganMinnesotaMissouriNorth CarolinaNew JerseyOhioPennsylvaniaSouth CarolinaTexasVirginiaWashington
Questions about this recall
Why was it recalled?
The Wireless Rechargers in the kits may be unable to enter a recharging session upon first use.
Which lots are affected?
RS6230 - GTIN 00763000564353, Serial numbers: NRA010637N; NRA011389N; NRA013260N; NRA013664N; NRA013924N; NRA014318N; NRA014347N; NRA015823N; NRA015861N; NRA015864N; NRA016334N; NRA016413N; NRA016430N; NRA016432N; NRA016778N; RA017002N; NRA017048N; NRA017227N; NRA017232N; NRA017685N; NRA018697N; NRA018731N; NRA018906N; NRA018936N; NRA018992N; NRA019019N; NRA019026N; NRA019963N; NRA019967N; NRA019968N; NRA019970N; NRA019983N; NRA010657N; NRA012367N; NRA012898N; NRA012915N; NRA013490N; NRA013643N; NRA013877N; NRA013878N; NRA013880N; NRA014248N; NRA014741N; NRA015127N; NRA015142N, NRA010659N; NRA010661N; NRA010663N NRA016424N; NRA016425N; NRA016426N; NRA016431N; RA016433N; NRA021324N. RS7230 - GTIN 00763000540289, Serial numbers: NRA010640N; NRA010650N; NRA010656N: NRA011591N; NRA012896N; NRA012910N; NRA012925N; NRA013884N; NRA010633N; NRA010635N; NRA010641N; NRA010642N; NRA010646N; NRA010652N; NRA010653N; NRA010654N; NRA010655N; NRA010658N; NRA010660N; NRA010664N; NRA010666N; NRA010667N; NRA010668N; NRA010669N; NRA010881N; NRA011216N; NRA011293N; NRA011393N; NRA011713N; NRA011853N; NRA012184N; NRA012897N; NRA012909N; NRA012911N; NRA012912N; NRA012913N; NRA012914N; NRA013502N; NRA013602N; NRA013603N; NRA013634N; NRA013635N; NRA013638N; NRA013639N; NRA013879N; NRA013883N; NRA013899N; NRA013952N; NRA014259N; NRA014944N; NRA015858N; NRA015904N; NRA011189N; NRA011238N; NRA012130N; NRA012185N; NRA012366N; NRA013543N; NRA014132N; NRA014222N; GTIN 0763000827533, Serial numbers: NRA010558N; NRA010627N; NRA015360N; NRA013633N.
Where was it sold?
Worldwide - US Nationwide distribution in the states of AL, AZ, CA, FL, GA, ID, MD, MI, MN, MO, NC, NJ, OH, PA, SC, TX, VA, and WA. The countries of Austria, Belgium, Denmark, Finland, Germany, Ireland, Italy, Japan, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, and United Kingdom.
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 Medtronic Neuromodulation
All 86| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medtronic Pocket Adaptor Kit for Deep Brain Stimulation recalled | Medtronic Neuromodulation | Other | Nationwide |
| Device | CLASS II | Medtronic Pocket Adaptor Kit for Deep Brain Stimulation recalled | Medtronic Neuromodulation | Other | Nationwide |
| Device | CLASS II | A71200 Vanta" Clinician Programmer Application (CP App) recalled | Medtronic Neuromodulation | Device Malfunction | Nationwide |
| Device | CLASS II | Restore Clinician Programmer Application (CP App) recalled | Medtronic Neuromodulation | Device Malfunction | Nationwide |
| Device | CLASS II | Enhanced Verify Evaluation Handset (CFN HH90130FA) recalled | Medtronic Neuromodulation | Device Malfunction | Nationwide |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |