Severity
Moderate
Sleek ***OTW ***Ref ***426-1501X***Inflated Balloon Dia/mm 1.5 Inflated Balloon Length/mm 15 Usable Catheter Length/cm 150***Lot 50026688***2013-09***Cordis***PTA Dilatation Catheter***Cordis***Johnson Johnson Company***Sterile***EO***Method of Sterilization: ETO***ClearStream***Clearstream Technologies, Ltd.***Moyne Upper, Enniscorthy Co Wexford, Ireland***Phone: +353-53-92-37111***Fax: +353-53-92-37-100***Made in Ireland***Distributed by: Cordis Cashel***Cahir Road, Cashel, Co. Tipperary, Irel
Reported: October 3, 2012 Initiated: January 31, 2011 #Z-2442-2012 1 unit units
Cordis Corporation issued this FDA Devices recall on October 3, 2012. Classified as Moderate severity (Class II). Approximately 1 unit units are affected. The recall was issued because: On 1//20/2011 Cordis Corporation , Miami Lakes, FL initiated a recall of their Sleek OTW PTA Dilatation Catheter Model …. This recall notice is sourced from official FDA Devices enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.
Recall Insight
This FDA Devices action (record #Z-2442-2012) was formally reported on October 3, 2012, with the manufacturer initiating the action on January 31, 2011. It is classified under Moderate severity (Class II), with a current status of Terminated. Cordis Corporation is listed as the recalling firm, operating out of Miami Lakes, FL. Federal records indicate 1 unit units are affected.
The documented reason for this recall is: On 1//20/2011 Cordis Corporation , Miami Lakes, FL initiated a recall of their Sleek OTW PTA Dilatation Catheter Model #4261201X Lot #50027149 and Model #4261501X Lot #50026688. Product is incorrectly labeled. Distribution data in the federal record shows the product reached: Worldwide Distribution - USA and Germany. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 14 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.
Recall Distribution by Severity Class
Units Affected
1 unit
Related Recalls
6
6 from same agency
Product Description
Sleek ***OTW ***Ref ***426-1501X***Inflated Balloon Dia/mm 1.5 Inflated Balloon Length/mm 15 Usable Catheter Length/cm 150***Lot 50026688***2013-09***Cordis***PTA Dilatation Catheter***Cordis***Johnson Johnson Company***Sterile***EO***Method of Sterilization: ETO***ClearStream***Clearstream Technologies, Ltd.***Moyne Upper, Enniscorthy Co Wexford, Ireland***Phone: +353-53-92-37111***Fax: +353-53-92-37-100***Made in Ireland***Distributed by: Cordis Cashel***Cahir Road, Cashel, Co. Tipperary, Ireland***". The SLEEK OTW Percutaneous Transluminal Angioplasty (PTA) Peripheral Catheter Family is a non-reusable semi-compliant coaxial design catheter with a balloon mounted on its distal tip. The hub/"Y" connector consists of a through lumen, allowing the catheter to track over a guidewire, and a balloon port, used to inflate the balloon. The catheter shaft is small beneath the balloon achieve low profile. The distal tip is further tapered to accept the appropriate guidewire. Platinum iridium bands serve to locate the balloon under fluoroscopy. A 0.014" (0.356 mm) guidewire is recommended for use with the SLEEK OTW Catheter.
Reason for Recall
On 1//20/2011 Cordis Corporation , Miami Lakes, FL initiated a recall of their Sleek OTW PTA Dilatation Catheter Model #4261201X Lot #50027149 and Model #4261501X Lot #50026688. Product is incorrectly labeled.
Details
- Recalling Firm
- Cordis Corporation
- Units Affected
- 1 unit
- Distribution
- Worldwide Distribution - USA and Germany
- Location
- Miami Lakes, FL
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2442-2012 |
| Date reported | October 3, 2012 |
| Date initiated | January 31, 2011 |
| Recalling firm | Cordis Corporation |
| Units affected | 1 unit |
| Distribution | Worldwide Distribution - USA and Germany |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
Frequently Asked Questions
What product was recalled? ▼
Sleek ***OTW ***Ref ***426-1501X***Inflated Balloon Dia/mm 1.5 Inflated Balloon Length/mm 15 Usable Catheter Length/cm 150***Lot 50026688***2013-09***Cordis***PTA Dilatation Catheter***Cordis***Johnson Johnson Company***Sterile***EO***Method of Sterilization: ETO***ClearStream***Clearstream Technologies, Ltd.***Moyne Upper, Enniscorthy Co Wexford, Ireland***Phone: +353-53-92-37111***Fax: +353-53-92-37-100***Made in Ireland***Distributed by: Cordis Cashel***Cahir Road, Cashel, Co. Tipperary, Ireland***". The SLEEK OTW Percutaneous Transluminal Angioplasty (PTA) Peripheral Catheter Family is a non-reusable semi-compliant coaxial design catheter with a balloon mounted on its distal tip. The hub/"Y" connector consists of a through lumen, allowing the catheter to track over a guidewire, and a balloon port, used to inflate the balloon. The catheter shaft is small beneath the balloon achieve low profile. The distal tip is further tapered to accept the appropriate guidewire. Platinum iridium bands serve to locate the balloon under fluoroscopy. A 0.014" (0.356 mm) guidewire is recommended for use with the SLEEK OTW Catheter.. Recalled by Cordis Corporation. Units affected: 1 unit.
Why was this product recalled? ▼
On 1//20/2011 Cordis Corporation , Miami Lakes, FL initiated a recall of their Sleek OTW PTA Dilatation Catheter Model #4261201X Lot #50027149 and Model #4261501X Lot #50026688. Product is incorrectly labeled.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 3, 2012. Severity: Moderate. Recall number: Z-2442-2012.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA and Germany.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2442-2012) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Data Sources
Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
- Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- U.S. Census Bureau ACS — demographic + housing + income data. census.gov/programs-surveys/acs
- BLS Occupational Employment and Wage Statistics (OEWS) — wage + employment by occupation. bls.gov/oes
- BEA Regional Economic Accounts — GDP + personal income by state/metro. bea.gov/data/regional
- U.S. Census Bureau County Business Patterns — establishment + employment by industry. census.gov/cbp
- IRS Statistics of Income (SOI) — tax-return aggregate data. irs.gov/statistics
- data.gov — U.S. federal open-data portal — discovery layer for additional federal sources. data.gov
Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).