25GA Subretinal Injection Cannula VS0220.25
US25GA Subretinal Injection Cannula VS0220.25
Recalling Firm: Vortex Surgical Inc.
Motivo del Retiro / Peligro
TranslatedThere may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
Descripción del Producto e Identificación
Translated25GA Subretinal Injection Cannula VS0220.25
Productos Afectados
Translated25GA Subretinal Injection Cannula VS0220.25
Additional Source Details
| Field | Value |
|---|---|
| City | Saint Charles |
| State | MO |
| Event id | 98255 |
| Address 1 | 4 Research Park Dr Ste 124 |
| Address 2 | N/A |
| Code info | Pouch UDI 810123480418 Box UDI 810123480692 Lot 2410043 |
| Postal code | 63304-5639 |
| Report date | 20260211 |
| Product type | Devices |
| Product quantity | 14,789 (8651 US; 6138 OUS) |
| Reason for recall | There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251216 |
| Initial firm notification | Letter |
| Center classification date | 20260204 |
Consumer Action Protocol: What You Should Do Immediately
Safety StepsInspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.
Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.
Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.
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 GuideQ1:What should I do immediately if I own or bought 25GA Subretinal Injection Cannula VS0220.25?
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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Resumen
- Empresa ResponsableVortex Surgical Inc.
- StatusOngoing
- Nivel de RiesgoClass II
- DistributionWorldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, CT, FL, HI, IA, IL, IN, KY, MA, MI, MN, MS, NC, NE, NJ, NM, NY, OH, OR, PA, RI, SC, SD, TN, TX, WA, WI, VA; and OUS (foreign) to countries of: Australia, Chile, China, France, Germany, India, Ireland, Italy, Japan, Korea, Mexico, Netherlands, Philippines, Poland, Puerto Rico, Spain, Switzerland, Taiwan, United Kingdom, Vietnam.
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🚨 SAFETY ALERT: Vortex Surgical Inc. - 25GA Subretinal Injection Cannula VS0220.25 Check if your household is affected: https://therecallfile.com/es/recalls/25ga-subretinal-injection-cannula-vs0220-25/FDA-Z-1248-2026
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