CLASS II ONGOING Device recall · Reported 7 Feb 2024 · FDA Enforcement Report
MB215R - Mills Durogrip TC Micro Needle Holder, straight recalled
Aesculap is recalling MB215R - Mills Durogrip TC Micro Needle Holder, straight, 8:, "TC Mills Ndle Holdrrnd, distributed nationwide in the US. The recall was initiated on 29 Dec 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-0867-2024
- FDA event ID
- 93793
- Recalling firm
- Aesculap, Center Valley, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 29 Dec 2023
- FDA classified
- 31 Jan 2024
- Reported
- 7 Feb 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Syringes & Needles
Timeline
| 29 Dec 2023 | Recall initiated by company | |
| 31 Jan 2024 | Classified by FDA | +33 days |
| 7 Feb 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
Needle Holder MB215R was inadvertently distributed as MB362R. Similarly, MB362R was distributed as MB215R during the affected distribution date range. The issue may lead to a short delay in procedure.
Product as listed by the FDA
MB215R - MILLS DUROGRIP TC Micro Needle Holder, straight, 8:, (203 mm), "TC MILLS NDLE HOLDRRND HNDLSTR203MM"
Where it was distributed
US Nationwide distribution in the states of CA, CO, FL, ID, KY, MD, MO, MT, NV, NY, OR, PA, RI, TN, TX, VA.
Nationwide CaliforniaColoradoFloridaIdahoKentuckyMarylandMissouriMontanaNevadaNew YorkOregonPennsylvaniaRhode IslandTennesseeTexasVirginia
Questions about this recall
Why was it recalled?
Needle Holder MB215R was inadvertently distributed as MB362R. Similarly, MB362R was distributed as MB215R during the affected distribution date range. The issue may lead to a short delay in procedure.
Which lots are affected?
UDI-DI 4046955075379 Firm did not identify affected lots or expiration date. Affected product was distributed between November 23, 2022 and October 6, 2023.
Where was it sold?
US Nationwide distribution in the states of CA, CO, FL, ID, KY, MD, MO, MT, NV, NY, OR, PA, RI, TN, TX, VA.
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.
Other products in this recall event
1 other product · FDA event 93793| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | MB362R - Jacobson Durogrip TC Micro Needle Holder, straight recalled | Aesculap | Other | Nationwide |
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|---|---|---|---|---|---|
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|---|---|---|---|---|---|
| Device | CLASS II | Embosphere 500-700 micrometer Syringe Sterile Steam recalled | Merit Medical Systems | Sterility | Nationwide |
| Device | CLASS II | IV Sets with drip chambers recalled by ICU Medical | ICU Medical | Particulate Matter | Nationwide |
| Device | CLASS II | IV Sets with drip chambers recalled by ICU Medical | ICU Medical | Particulate Matter | Nationwide |
| Device | CLASS II | Medrad¿ Stellant Flex Syringe Kit used recalled by Bayer Medical Care | Bayer Medical Care | Sterility | Nationwide |
| Device | CLASS II | IV Sets with drip chambers recalled by ICU Medical | ICU Medical | Particulate Matter | Nationwide |