CLASS II ONGOING Device recall · Reported 22 Jan 2025 · FDA Enforcement Report
X-Flow prostatectomy catheter recalled by Coloplast Manufacturing US
Coloplast Manufacturing US is recalling X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, distributed nationwide in the US. The recall was initiated on 2 Dec 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0845-2025
- FDA event ID
- 95895
- Recalling firm
- Coloplast Manufacturing US, Minneapolis, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 2 Dec 2024
- FDA classified
- 10 Jan 2025
- Reported
- 22 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 2 Dec 2024 | Recall initiated by company | |
| 10 Jan 2025 | Classified by FDA | +39 days |
| 22 Jan 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB6122, AB6124, AB6220, AB6222, AB6224, AB6318, AB6320, AB6322, AB6324, AB6418, AB6420, AB6422, AB6424, AB6522, AB6524, AB6A18, AB6A20, AB6A22, AB6A24, AB6C18, AB6C20, AB6C22, and AB6C24.
Where it was distributed
US Nationwide. Canada.
Questions about this recall
Why was it recalled?
A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
Which lots are affected?
Device Reference Number AB6022, GTIN 3600040143377, Lot Numbers: 8884608, 9132241, 9213522, 9396680, 9404775, 9495823, 9495824 ; Device Reference Number AB6024, GTIN 3600040143506, Lot Numbers: 8156931, 8865281, 9102857, 9453594 ; Device Reference Number AB6118, GTIN 3600040143636, Lot Numbers: 8691180; Device Reference Number AB6120, GTIN 3600040143728, Lot Numbers: 8839916, 9090719, 9112199, 9177734, 9622870, 9690290 ; Device Reference Number AB6122, GTIN 3600040143810, Lot Numbers: 7562886, 7562887; Device Reference Number AB6124, GTIN 3600040143902, Lot Numbers: 7396107, 9102869, 9429206 ; Device Reference Number AB6220, GTIN 3600040144046, Lot Numbers: 8460192, 8529285; Device Reference Number AB6222, GTIN 3600040144091, Lot Numbers: 8442243, 8459924, 8529346, 8592925, 8806400; Device Reference Number AB6224, GTIN 3600040144145, Lot Numbers: 8442214, 8559578, 9112300 ; Device Reference Number AB6318, GTIN 3600040144190, Lot Numbers: 7637490, 7670546, 8484834, 8498250, 8529294, 8529295 ; Device Reference Number AB6320, GTIN 3600040144329, Lot Numbers: 7416561, 8030228, 8268284, 8296927, 8296928, 8296931, 8296942, 8296955, 8484916, 8691201, 8749915, 9008517, 9008535, 9067831, 9090787, 9112219, 9122900, 9304719, 9341183, 9341188, 9362273, 9374219, 9374226, 9396727, 9396729, 9396730, 9420755, 9420756, 9429254, 9445832, 9445833, 9453638, 9472408, 9498273, 9530041, 9553590, 9792275; Device Reference Number AB6322, GTIN 3600040144459, Lot Numbers: 7338758, 7350593, 7713988, 7727275, 7727278, 7968373, 7977166, 7998276, 8008140, 8087091, 8255376, 8385860, 8506852, 8572895, 8749880, 8884710, 8931589, 8948207, 9031577, 9055067, 9077790, 9102922, 9282729, 9316049, 9342015, 9390309, 9863033, 9888907, 9899174, 9920693, 9920694; Device Reference Number AB6324, GTIN 3600040144589, Lot Numbers: 7161442, 7187947, 7427129, 7494289, 7704381, 7727266, 7959383, 7959384, 7959385, 8008223, 8097934, 8097935, 8097937, 8341187, 8484780, 8484784, 8519827, 8608136, 8742649, 8884484, 8884485, 8923570, 8923572, 9008605, 9053873, 9102865, 9132280, 9261342, 9342043, 9342044, 9375106, 9429327, 9553583, 9571012, 9666667, 9683032; Device Reference Number AB6418, GTIN 3600040144718, Lot Numbers: 8679531; Device Reference Number AB6420, GTIN 3600040144787, Lot Numbers: 8749847; Device Reference Number AB6422, GTIN 3600040144855, Lot Numbers: 8030359, 9192331, 9404762; Device Reference Number AB6424, GTIN 3600040144923, Lot Numbers: 8050720, 9053872, 9843641 ; Device Reference Number AB6522, GTIN 3600040145135, Lot Numbers: 9700704; Device Reference Number AB6524, GTIN 3600040145203, Lot Numbers: 7606773; Device Reference Number AB6A18, GTIN 3600040145838, Lot Numbers: 7387183, 7416523, 7447569, 7504520, 7969002, 8484935, 8593017, 8691164, 8839744, 8865285, 8884610, 8996730, 9090499, 9090500, 9201866, 9201868, 9351867, 9351868, 9778587, 9888888; Device Reference Number AB6A20, GTIN 3600040145906, Lot Numbers: 7187871, 7238887, 7326866, 7405932, 7487264, 7646979, 7646980, 7694201, 8519729, 8519730, 8592981, 8656316, 8749861, 8765663, 8829366, 8853825, 8865362, 8911324, 8911325, 8931643, 8997524, 8997525, 9031251, 9159893, 9159894, 9177746, 9351843, 9362261, 9374229, 9419454, 9445814, 9472372, 9540992, 9558678, 9558679, 9558680 ; Device Reference Number AB6A22, GTIN 3600040145975, Lot Numbers: 7171321, 7290540, 7338690, 7350471, 7440879, 7469993, 7469995, 7469996, 7504590, 7516900, 7680717, 7694159, 7773602, 7810082, 7948506, 7968353, 7998159, 8008112, 8008113, 8097918, 8111866, 8289277, 8289280, 8289282, 8459856, 8529306, 8529307, 8529308, 8608132, 8765655, 8806462, 8839832, 8839833, 8839835, 8865393, 8865394, 8923543, 8923544, 8996594, 8996596, 9008485, 9019036, 9031180, 9031191, 9055054, 9201841, 9240207, 9282369, 9294592, 9461963, 9461964, 9472329, 9505126, 9558646, 9817372, 9829430, 9849265 ; Device Reference Number AB6A24, GTIN 3600040146040, Lot Numbers: 7362278, 7362280, 7387201, 7469990, 7504565, 7694210, 7714088, 8111864, 8255345, 8350315, 8498243, 8603744, 8742657, 8765683, 8853712, 8865439, 9031093, 9041479, 9159898, 9177566, 9374196, 9374197, 9385383, 9446056, 9937345 ; Device Reference Number AB6C18, GTIN 3600040146316, Lot Numbers: 8418135, 9683014 ; Device Reference Number AB6C20, GTIN 3600040146361, Lot Numbers:7908260, 8268412, 8350306, 8408126, 8529315 ; Device Reference Number AB6C22, GTIN 3600040146415, Lot Numbers: 8559519, 8619991, 8656312, 8691203, 8829379, 9018625, 9141394, 9374181 ; Device Reference Number AB6C24, GTIN 3600040146460, Lot Numbers: 9634480;
Where was it sold?
US Nationwide. Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 95895| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Folysil Silicone Foley Catheters recalled by Coloplast Manufacturing US | Coloplast Manufacturing US | Sterility | Nationwide |
More recalls from Coloplast Manufacturing US
All 28| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Folysil Silicone Foley Catheters recalled by Coloplast Manufacturing US | Coloplast Manufacturing US | Sterility | Nationwide |
| Device | CLASS II | Ureteral dilator recalled by Coloplast Manufacturing US | Coloplast Manufacturing US | Sterility | 9 states |
| Device | CLASS II | Titan NB Infra Zero Ang recalled by Coloplast Manufacturing US | Coloplast Manufacturing US | Device Malfunction | Nationwide |
| Device | CLASS II | Titan Touch Pump recalled by Coloplast Manufacturing US | Coloplast Manufacturing US | Device Malfunction | Nationwide |
| Device | CLASS II | Titan 0-Deg Scrotal recalled by Coloplast Manufacturing US | Coloplast Manufacturing US | Device Malfunction | Nationwide |
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