Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

Fixed Core Wire Guide (Safe-T-J Curved), Guidewire Reference Part Number/GPN: TSCF-25-180-3 G01...

FDA Device Recall #Z-1833-2022 — Class II — August 16, 2022

Recall Summary

Recall Number Z-1833-2022
Classification Class II — Moderate risk
Date Initiated August 16, 2022
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Cook Incorporated
Location Bloomington, IN
Product Type Devices
Quantity 9,903 US; 5,185 OUS

Product Description

Fixed Core Wire Guide (Safe-T-J Curved), Guidewire Reference Part Number/GPN: TSCF-25-180-3 G01602 TSCF-35-180-3 G00902 TSCF-21-260-3 G00455 THSCF-25-260-3 G02384 TSCF-25-145-3 G00466 THSCF-35-80-3 G04069 THSCF-35-180-15 G01151 TSCF-21-50-3 G00456 THSCF-35-145-3 G00412 TSCF-35-145-15 G00509 TSCF-35-145-1.5 G00507 TSCF-35-145-3 G00511 TSCF-38-80-3 G00552 TSCF-18-180-3 G02160 TSCF-35-80-3 G00529 TSCF-21-180-3 G01793 TSCF-25-260-3 G00471 C-SCF-18-50-3 G02050 C-SCF-18-40-2 G02659 C-SCF-25-50-3 G02180 TSCF-18-80-3 G00441 C-SCF-15-30-2 G06973

Reason for Recall

Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.

Distribution Pattern

Domestic distribution nationwide. Foreign distribution worldwide.

Lot / Code Information

TSCF-25-180-3 G01602 UDI-DI: 00827002016026 Lots/Expiration Dates: 14769750 03-06-2027 14795053 15-06-2027 14818416 29-06-2027 TSCF-35-180-3 G00902 UDI-DI: 00827002009028 Lots/Expiration Dates: 14774744 07-06-2027 14793143 14-06-2027 14793144 14-06-2027 14795155 15-06-2027 14795156 15-06-2027 14795157 15-06-2027 14797503 16-06-2027 14798672 16-06-2027 14805743 21-06-2027 14805744 21-06-2027 14816671 28-06-2027 14821171 30-06-2027 14822357 30-06-2027 14822382 30-06-2027 14822383 30-06-2027 TSCF-21-260-3 G00455 UDI-DI: 00827002004559 Lots/Expiration Dates: 14795051 15-06-2027 14813712 27-06-2027 THSCF-25-260-3 G02384 UDI-DI: 00827002023840 Lots/Expiration Dates: 14795058 15-06-2027 TSCF-25-145-3 G00466 UDI-DI: 00827002004665 Lots/Expiration Dates: 14795071 15-06-2027 THSCF-35-80-3 G04069 UDI-DI: 00827002040694 Lots/Expiration Dates: 14797500 16-06-2027 14803099 20-06-2027 14830991 07-07-2027 14832155 07-07-2027 14837668 12-07-2027 14843270 15-07-2027 THSCF-35-180-15 G01151 UDI-DI: 00827002011519 Lots/Expiration Dates: 14798678 16-06-2027 TSCF-21-50-3 G00456 UDI-DI: 00827002004566 Lots/Expiration Dates: 14802358 20-06-2027 THSCF-35-145-3 G00412 UDI-DI: 00827002004122 Lots/Expiration Dates: 14803096 20-06-2027 TSCF-35-145-15 G00509 UDI-DI: 00827002005099 Lots/Expiration Dates: 14803101 20-06-2027 TSCF-35-145-1.5 G00507 UDI-DI: 00827002005075 Lots/Expiration Dates: 14803102 20-06-2027 TSCF-35-145-3 G00511 UDI-DI: 00827002005112 Lots/Expiration Dates: 14803184 20-06-2027 14811921 24-06-2027 14811922 24-06-2027 14811923 24-06-2027 14811924 24-06-2027 14811925 24-06-2027 14815767 27-06-2027 14815768 27-06-2027 14815769 27-06-2027 14815770 27-06-2027 14826198 05-07-2027 14826199 05-07-2027 14826200 05-07-2027 14826201 05-07-2027 14826202 05-07-2027 14831157 07-07-2027 14831158 07-07-2027 14831159 07-07-2027 14831160 07-07-2027 14831162 07-07-2027 14835711 11-07-2027 14835712 11-07-2027 14835713 11-07-2027 14835715 11-07-2027 14835716 11-07-2027 14841791 14-07-2027 14841792 14-07-2027 14843520 15-07-2027 NS14841787 14-07-2027 TSCF-38-80-3 G00552 UDI-DI: 00827002005525 Lots/Expiration Dates: 14805745 21-06-2027 NS14805905 07-07-2027 TSCF-18-180-3 G02160 UDI-DI: 00827002021600 Lots/Expiration Dates: 14807601 22-06-2027 TSCF-35-80-3 G00529 UDI-DI: 00827002005297 Lots/Expiration Dates: 14808542 22-06-2027 14808543 22-06-2027 14808544 22-06-2027 14808547 22-06-2027 14808548 22-06-2027 14814967 27-06-2027 14814968 27-06-2027 14814969 27-06-2027 14814970 27-06-2027 14814971 27-06-2027 14814972 27-06-2027 14814973 27-06-2027 TSCF-21-180-3 G01793 UDI-DI: 00827002017931 Lots/Expiration Dates: 14813705 27-06-2027 TSCF-25-260-3 G00471 UDI-DI: 00827002004719 Lots/Expiration Dates: 14818414 29-06-2027 14818415 29-06-2027 C-SCF-18-50-3 G02050 UDI-DI: 00827002020504 Lots/Expiration Dates: NS14797765 16-06-2027 NS14802360 20-06-2027 NS14818383 29-06-2027 NS14827374 05-07-2027 C-SCF-18-40-2 G02659 UDI-DI: 00827002026599 Lots/Expiration Dates: NS14802359 20-06-2027 NS14818385 29-06-2027 C-SCF-25-50-3 G02180 UDI-DI: 00827002021808 Lots/Expiration Dates: NS14818386 29-06-2027 TSCF-18-80-3 G00441 UDI-DI: 00827002004412 Lots/Expiration Dates: NS14821725 30-06-2027 C-SCF-15-30-2 G06973 UDI-DI: 00827002069732 Lots/Expiration Dates: NS14821726 30-06-2027

Other Recalls from Cook Incorporated

Recall # Classification Product Date
Z-0995-2026 Class II R¿sch-Uchida Transjugular Liver Access Sets, Re... Nov 26, 2025
Z-0993-2026 Class II Flexor Check-Flo Introducers and Sets, Referenc... Nov 26, 2025
Z-0994-2026 Class II Ring Transjugular Intrahepatic Access Sets, Ref... Nov 26, 2025
Z-1902-2025 Class I Beacon Tip 5.0 Fr Angiographic catheters are de... May 15, 2025
Z-1786-2025 Class II Check=Flo Performer Introducer, 10.0Fr, Referen... Apr 17, 2025

Frequently Asked Questions

Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

More from Cook Incorporated Recalls by Firm Recall Reasons Device Safety Stats