da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15
USda Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15
Recalling Firm: Intuitive Surgical, Inc.
Motivo del Retiro / Peligro
TranslatedRobotic-assisted surgical system arm drapes may detach from the instrument arm due to an issue involving the drape rings located at the top of the product, which may expose a section of instrument arm, which may result in procedure delay or conversion to an alternate minimally invasive approach. Retrospectively reported recall.
Descripción del Producto e Identificación
Translatedda Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15
Additional Source Details
| Field | Value |
|---|---|
| City | Sunnyvale |
| State | CA |
| Event id | 98890 |
| Address 1 | 1266 Kifer Rd |
| Code info | UDI-DI: 00886874113486, Lot: 3074LA0500, 1124LA0200, 2124LA0400, 1134LA0700, 1144LA0500, 7154LA0200, 6164LA0800, 1084LA0300, 3164LAA800, 4084LA0500, 4124LA0600, 1274LA0500, 2294LA0200, 1274LA0400, 4284LA0800, 6324LA0200, 1324LA0300, 4154LA0400, 2284LA0100, 4144LA1300, 3324LA0500, 2354LA0500, 7144LA0500, 4294LA0700, 3374LA0400, 5264LA0700, 3224LA0500, 3424LA0200, 1394LA0100 |
| Postal code | 94086-5304 |
| Report date | 20260722 |
| Product type | Devices |
| Product quantity | 11113 |
| Reason for recall | Robotic-assisted surgical system arm drapes may detach from the instrument arm due to an issue involving the drape rings located at the top of the product, which may expose a section of instrument arm, which may result in procedure delay or conversion to an alternate minimally invasive approach. Retrospectively reported recall. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20250512 |
| Center classification date | 20260710 |
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 da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15?
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 ResponsableIntuitive Surgical, Inc.
- StatusOngoing
- Nivel de RiesgoClass II
- DistributionWorldwide - US Nationwide distribution in the states of NJ, OR, NY, FL, AL, SD, TX, VA, WV, PA, CA, WA, CT, MA, IL, OK, OH, MI, NC, MO, KY, WI, AZ, CO, GA, MD, SC, IN, NV, TN, MS, KS, IA, UT, MN, LA, NE, ME and the countries of Germany, Sweden, United Kingdom, Italy, Belgium, Switzerland, Denmark, Japan, South Korea, Hong Kong, Taiwan, France, Ireland, Spain.
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🚨 SAFETY ALERT: Intuitive Surgical, Inc. - da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15 Check if your household is affected: https://therecallfile.com/es/recalls/da-vinci-sp-instrument-arm-drape-sp-1-pack-part-number-430013-13-43001/FDA-Z-2722-2026
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