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FDA DevicesClass II

Surgipro SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X36 SP-623

Published: August 19, 2026Recall ID: Z-2921-2026Category: Medical DevicesCountry: United States
US
Medical DeviceFDA DevicesUSUS

Surgipro SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X36 SP-623

Recalling Firm: Covidien, LP

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Reason for Recall / Hazard

Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.

Product Description & Identification

Surgipro SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X36 SP-623

Affected Products

Surgipro SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X36 SP-623

Additional Source Details

FieldValue
CityNorth Haven
StateCT
Event id99390
Address 160 Middletown Ave
Code infoSP-623 UDI-DI 20884521037073 Lot D6A2963Y
Postal code06473-3908
Report date20260819
Product typeDevices
Product quantity135,875 total
Reason for recallProduct may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260624
Initial firm notificationLetter
Center classification date20260807

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 Surgipro SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X36 SP-623?

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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Overview

  • Recalling FirmCovidien, LP
  • StatusOngoing
  • Risk LevelClass II
  • DistributionUS Nationwide and the countries of Australia, Austria, Belgium, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Guadeloupe, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kosovo, Lebanon, Lithuania, Luxembourg, Mexico, Namibia, Netherlands, North Macedonia, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan.
Recall Hazard Severity
High Alert (Class I)
Official Agency Alert

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🚨 SAFETY ALERT: Covidien, LP - Surgipro SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X36 SP-623

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https://therecallfile.com/recalls/surgipro-sp-623-surgipro-2-0-blu-75cm-sc2-x36-sp-623/FDA-Z-2921-2026
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