FDA DevicesClass II

STRYKER PKG., SINGLE SPIKE TUBE SET, Catalog Number 0250070530

Publicado: 12 de agosto de 2026ID de Retiro: Z-2865-2026Categoría: Dispositivos MédicosPaís: Estados Unidos
US
Medical DeviceFDA DevicesUSUS

STRYKER PKG., SINGLE SPIKE TUBE SET, Catalog Number 0250070530

Recalling Firm: Stryker Corporation

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Motivo del Retiro / Peligro

There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.

Descripción del Producto e Identificación

STRYKER PKG., SINGLE SPIKE TUBE SET, Catalog Number 0250070530

Additional Source Details

FieldValue
CitySan Jose
StateCA
Event id99340
Address 15900 Optical Ct
Code infoGTIN 07613327061352, Batch Numbers 24260FG2, 24261FG2, 24297FG2, 24298FG2, 24299FG2, 24302FG2, 24340FG2, 24341FG2, 25008FG2, 25009FG2, 25010FG2, 25011FG2, 25024FG2, 25034FG2, 25035FG2, 25052FG2, 25063FG2, 25064FG2, 25084FG2, 25092FG2, 25093FG2, 25121FG2, 25134FG2, 25135FG2, 25153FG2, 25154FG2, 25167FG2, 25182FG2, 25183FG2, 25216FG2, 25217FG2, 25245FG2, 25274FG2.
Postal code95138-1400
Report date20260812
Product typeDevices
Product quantity11,857 Units
Reason for recallThere has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260608
Initial firm notificationLetter
Center classification date20260803

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 STRYKER PKG., SINGLE SPIKE TUBE SET, Catalog Number 0250070530?

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 ResponsableStryker Corporation
  • StatusOngoing
  • Nivel de RiesgoClass II
  • DistributionWorldwide distribution - US Nationwide and the countries of Australia, Brazil, Canada, Chile, France, Germany, Indonesia, Italy, Mexico, Netherlands, New Zealand, Philippines, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom.
Recall Hazard Severity
High Alert (Class I)
Alerta Oficial de la Agencia

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🚨 SAFETY ALERT: Stryker Corporation - STRYKER PKG., SINGLE SPIKE TUBE SET, Catalog Number 0250070530

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https://therecallfile.com/es/recalls/stryker-pkg-single-spike-tube-set-catalog-number-0250070530/FDA-Z-2865-2026
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