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FDA DevicesClass II

Dentsply Sirona Capsule Mixer Model No. 5546068

Veröffentlicht: 26. August 2026Rückruf-ID: Z-2954-2026Kategorie: MedizinprodukteLand: Vereinigte Staaten
US
Medical DeviceFDA DevicesUSUS

Dentsply Sirona Capsule Mixer Model No. 5546068

Recalling Firm: SDI Limited

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Mitteilung übersetzenTranslate notice text, hazard warnings, and descriptions into any supported language.

Grund für den Rückruf / Gefahr

Potential for electrical discharge from unit when unplugged.

Produktbeschreibung & Identifikation

Dentsply Sirona Capsule Mixer Model No. 5546068

Betroffene Produkte

Dentsply Sirona Capsule Mixer Model No. 5546068

Additional Source Details

FieldValue
CityBayswater
Event id99322
Address 13-15 Brunsdon St
Code infoUDI:9336472005542; Serial Numbers 0003-1533
Postal codeN/A
Report date20260826
Product typeDevices
Product quantity1,444 units
Reason for recallPotential for electrical discharge from unit when unplugged.
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260720
Initial firm notificationLetter
Center classification date20260814

Consumer Action Protocol: What You Should Do Immediately

Safety Steps
1Verify Product Identifiers

Inspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.

2Isolate & Discontinue Use

Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.

3Claim Free Statutory Remedy

Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.

4Report Adverse Incidents

If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (FDA Devices).

Your Legal Rights as a Consumer

Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.

Frequently Asked Questions About This Recall

FAQ Guide

Q1:What should I do immediately if I own or bought Dentsply Sirona Capsule Mixer Model No. 5546068?

Check the lot number and NDC on your prescription label. For essential medications, consult your doctor or dispensing pharmacist immediately before abruptly stopping your dose.

Q2:Can I get a full refund or free repair for this recall?

Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.

Q3:Do I need my original sales receipt to claim a remedy or refund?

In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.

Q4:Where can I verify official information for this safety alert?

This safety alert is aggregated directly from official regulatory agency records (FDA Devices). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.

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Übersicht

  • Rückrufendes UnternehmenSDI Limited
  • StatusOngoing
  • RisikostufeClass II
  • DistributionUS: AK AL AR AZ CA CO CT DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC NE NH NJ NM NV NY OH OK OR PA RI SC SD TN TX UT VA VT WA WI WV OUS: None
Recall Hazard Severity
High Alert (Class I)
Offizielle Behördenwarnung

📢 Warnung teilen

Alert family and friends to keep them safe. Copy this quick alert message:

🚨 SAFETY ALERT: SDI Limited - Dentsply Sirona Capsule Mixer Model No. 5546068

Check if your household is affected:
https://therecallfile.com/de/recalls/dentsply-sirona-capsule-mixer-model-no-5546068/FDA-Z-2954-2026
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