Cerenovus Inc recalls CEREPAK Detachable Coil System - Name/REF: UNIFORM 2MM X 2.5 CM/FCX100202
Reason for recall
Detachable coils system may fail to detach, which could result in hemorrhagic and ischemic stroke, procedural delays, or the need for additional surgical intervention.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- CEREPAK Detachable Coil System - Name/REF: UNIFORM 2MM X 2.5 CM/FCX100202, UNIFORM 2.5MM X 3.3 CM/FCX100253, UNIFORM 3MM X 5.4 CM/FCX100305, UNIFORM 3.5MM X 6.6 CM/FCX100356, UNIFORM 4MM X 7.5 CM/FCX100407, UNIFORM 4MM X 11.5 CM/FCX100412, UNIFORM 5MM X 9.7 CM/FCX100509, UNIFORM 5MM X 17 CM/FCX100517, UNIFORM 6MM X 11.9 CM/FCX100611, UNIFORM 6MM X 26 CM/FCX100626, UNIFORM 7MM X 13.9 CM/FCX100713, UNIFORM 7MM X 30 CM/FCX100730, UNIFORM 8MM X 16.1 CM/FCX100816, UNIFORM 8MM X 29 CM/FCX100829, UNIFORM 3D 2MM X 2.5 CM/FCX140225, UNIFORM 3D 3MM X 3 CM/FCX140303, UNIFORM 3D 3MM X 4 CM/FCX140304, UNIFORM 3D 3MM X 6 CM/FCX140306, UNIFORM 3D 4MM X 6 CM/FCX140406, UNIFORM 3D 4MM X 8 CM/FCX140408, UNIFORM 3D 4MM X 4.5 CM/FCX140445, UNIFORM 3D 5MM X 7 CM/FCX140507, UNIFORM 3D 5MM X 12 CM/FCX140512, UNIFORM 3D 6MM X 9 CM/FCX140609, UNIFORM 3D 6MM X 15 CM/FCX140615, UNIFORM 3D 7MM X 11 CM/FCX140711, UNIFORM 3D 7MM X 17 CM/FCX140717, UNIFORM 3D 8MM X 12 CM/FCX140812, UNIFORM 3D 8MM X 20 CM/FCX140820, UNIFORM 3D 9MM X 14 CM/FCX140914, UNIFORM 3D 9MM X 22 CM/FCX140922, UNIFORM 3D 10MM X 16 CM/FCX141016, UNIFORM 3D 10MM X 25 CM/FCX141025, UNIFORM 3D 11MM X 18 CM/FCX141118, UNIFORM 3D 11MM X 27 CM/FCX141127, UNIFORM 3D 12MM X 19 CM/FCX141219, UNIFORM 3D 12MM X 30 CM/FCX141230, UNIFORM XL 5MM X 10 CM/FCX180510, UNIFORM XL 6MM X 12.2 CM/FCX180612, UNIFORM XL 7MM X 14.3 CM/FCX180714, UNIFORM XL 8MM X 13.6 CM/FCX180813, UNIFORM XL 8MM X 30 CM/FCX180830, UNIFORM XL 9MM X 15.3 CM/FCX180915, UNIFORM XL 9MM X 33 CM/FCX180933, UNIFORM XL 10MM X 17.1 CM/FCX181017, UNIFORM XL 10MM X 34 CM/FCX181034, UNIFORM XL 11MM X 18.9 CM/FCX181118, UNIFORM XL 11MM X 37 CM/FCX181137, UNIFORM XL 12MM X 20.7 CM/FCX181220, UNIFORM XL 12MM X 40 CM/FCX181240, UNIFORM XL 13MM X 43 CM/FCX181343, UNIFORM XL 14MM X 47 CM/FCX181447, UNIFORM XL 15MM X 50 CM/FCX181550, UNIFORM XL 16MM X 47 CM/FCX181647, UNIFORM XL 17MM X 50 CM/FCX181750, UNIFORM XL 18MM X 46 CM/FCX181846, UNIFORM XL 19MM X 50 CM/FCX181950, UNIFORM XL 20MM X 50 CM/FCX182050, FREEFORM MINI 1MM X 1CM/MCR091010, FREEFORM MINI 1MM X 1.5CM/MCR091015, FREEFORM MINI 1MM X 2CM/MCR091020, FREEFORM MINI 1MM X 2.5CM/MCR091025, FREEFORM MINI 1MM X 3CM/MCR091030, FREEFORM MINI 1MM X 4CM/MCR091040, FREEFORM MINI 1.5MM X 2CM/MCR091520, FREEFORM MINI 1.5MM X 2.5CM/MCR091525, FREEFORM MINI 1.5MM X 3CM/MCR091530, FREEFORM MINI 1.5MM X 4CM/MCR091540, FREEFORM MINI 2MM X 2CM/MCR092020, FREEFORM MINI 2MM X 3CM/MCR092030, FREEFORM MINI 2MM X 4CM/MCR092040, FREEFORM MINI 2MM X 6CM/MCR092060, FREEFORM MINI 2.5MM X 3.5CM/MCR092535, FREEFORM MINI 2.5MM X 4.5CM/MCR092545, FREEFORM MINI 2.5MM X 5.5CM/MCR092555, FREEFORM MINI 3MM X 4CM/MCR093040, FREEFORM MINI 3MM X 6CM/MCR093060, FREEFORM MINI 3MM X 8CM/MCR093080, FREEFORM 2MM X 2 CM/SCR120202, FREEFORM 3MM X 6 CM/SCR120306, FREEFORM 3MM X 8 CM/SCR120308, FREEFORM 4MM X 7 CM/SCR120407, FREEFORM 4MM X 10 CM/SCR120410, FREEFORM 4MM X 12 CM/SCR120412, FREEFORM 5MM X 10 CM/SCR120510, FREEFORM 5MM X 15 CM/SCR120515, FREEFORM 6MM X 10 CM/SCR120610, FREEFORM 6MM X 15 CM/SCR120615, FREEFORM 6MM X 20 CM/SCR120620, FREEFORM 7MM X 15 CM/SCR120715, FREEFORM 7MM X 21 CM/SCR120721, FREEFORM 8MM X 15 CM/SCR120815, FREEFORM 8MM X 24 CM/SCR120824, FREEFORM 9MM X 25 CM/SCR120925, FREEFORM 10MM X 30 CM/SCR121030, FREEFORM 12MM X 30 CM/SCR121230, FREEFORM 2.5MM X 5 CM/SCR122505, FREEFORM 2.5MM X 3.5 CM/SCR122535, FREEFORM 3.5MM X 9 CM/SCR123509, FREEFORM 3.5MM X 7.5 CM/SCR123575, HELIFORM SOFT 1.5MM X 4 CM/SHD100154, HELIFORM SOFT 2MM X 8 CM/SHD100208, HELIFORM SOFT 2.5MM X 10 CM/SHD100250, HELIFORM SOFT 2.5MM X 8 CM/SHD100258, HELIFORM SOFT 3MM X 8 CM/SHD100308, HELIFORM SOFT 3MM X 10 CM/SHD100310, HELIFORM SOFT 4MM X 8 CM/SHD100408, HELIFORM SOFT 4MM X 10 CM/ SHD100410, HELIFORM SOFT 5MM X 10 CM/ SHD100510, HELIFORM SOFT 5MM X 15 CM/ SHD100515, HELIFORM SOFT 6MM X 12 CM/ SHD100612, HELIFORM SOFT 6MM X 16 CM/ SHD100616, HELIFORM SOFT 7MM X 16 CM/ SHD100716, HELIFORM SOFT 7MM X 20 CM/ SHD100720, HELIFORM SOFT8MMUDI-DI FCX100202/10886704083986168 affected lots2025FCX100202/10886704083986FCX100253/10886704083979FCX100305/10886704083962FCX100356/10886704083993FCX100407/10886704084013FCX100412/10886704084006FCX100509/10886704084037
+160 more
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
What the firm is doing
On 10/2/2025, Johnson & Johnson Med Tech mailed "URGENT: MEDICAL DEVICE RECALL (REMOVAL)" notices dated 10/1/2025 to customers who were asked to do the following: 1. Immediately stop using the affected devices. 2. Identify and segregate all affected devices that are in inventory / consignment at your facility. 3. Firm sales representative will coordinate the removal of the product from your facility and will coordinate the credit, as applicable, for any customer-owned inventory. 4. Communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. 5. If any product subject to this recall has been forwarded to another facility, contact that facility, provide a copy of this letter and notify J&J sales representative. 6. If the product has been successfully implanted, there is no additional action needed. 7. Complete and return the attached Business Reply Form in Attachment 2 to: OneMD-Field-Actions@its.jnj.com. Please return the BRF even if you do not have product subject to this recall. 8. Keep this notice visibly posted for awareness until all product subject to this recall have been returned. While processing your returns, please maintain a copy of this notice with the product subject to this recall and keep a copy for your records. If you have additional questions regarding this medical device recall (removal), please contact firm at OneMD-Field-Actions@its.jnj.com.
DistributionShow detailsHide
US Nationwide distribution: CO, GA, MD, UT, OK, WI, MA, TN, SC, TX, CA, WV, LA, IL, NY, IA, AZ, AL, CT, WA, OH, ME, DC, FL, SD, KY, NJ, DE, NC, PA, MI, MO, VA, NH, NV and OR.
A reasonable probability that use of the product will cause serious adverse health consequences or death.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-0434-2026
- FDA 510(k) clearance · K220040The device's official FDA premarket clearance record
- FDA device classification · HCGOfficial FDA classification for this device type
- CFR regulation · 21 CFR 882.5950The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Cerenovus IncSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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