Porges Coloplast recallZ-0845-2025 · Coloplast Manufacturing US, LLC · initiated Dec 2, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Coloplast Manufacturing US, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
FDA root cause category: Packaging
What the company is doing
An URGENT MEDICAL DEVICE VOLUNTARY RECALL notification letter dated 12/2/24 was sent to customers. Distributors, it is imperative that you take immediate action to cascade this recall notice to all relevant subsidiaries and customers who may have received the affected product within your distribution network. Customers affected by this recall are kindly advised to immediately inspect their internal inventory and quarantine all products and samples of the items with the lot numbers mentioned in Appendix 1 and then proceed to safe destruction. Please contact Customer Service for any assistance: Email: [email protected] Phone: +1 855 745 8549 Expenses will be refunded by Coloplast A/S upon receipt of the completed Certificate of Destruction provided in Appendix 2.
Recall details
- Recall number
- Z-0845-2025
- Status
- Open, Classified
- Initiated by the company
- Dec 2, 2024
- Posted by the FDA
- Jan 10, 2025
- Recalling firm
- Coloplast Manufacturing US, LLC
- Quantity
- 36,369 units
- Product code
- EZL
- FDA submissions
- K013172
- Distribution
- US Nationwide. Canada.
Product description
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.
Code information (models, lots, serial numbers)
Show the full code information (5k characters)
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;
Devices named in this recall
27 devices in the FDA device registry whose identifier appears in the recall's code information.
- Porges Coloplast AB6318Coloplast A/S · CATHETER, RETENTION TYPE, BALLOON1 recall45 reports
- Porges Coloplast AB6322Coloplast A/S · CATHETER, RETENTION TYPE, BALLOON1 recall34 reports
- Porges Coloplast AB6320Coloplast A/S · CATHETER, RETENTION TYPE, BALLOON1 recall32 reports
- Porges Coloplast AB6118Coloplast A/S · CATHETER, RETENTION TYPE, BALLOON1 recall9 reports
- Porges Coloplast AB6120Coloplast A/S · CATHETER, RETENTION TYPE, BALLOON1 recall9 reports
- Porges Coloplast AB6222Coloplast A/S · CATHETER, RETENTION TYPE, BALLOON1 recall8 reports
- Porges Coloplast AB6324Coloplast A/S · CATHETER, RETENTION TYPE, BALLOON1 recall8 reports
- Porges Coloplast AB6022Coloplast A/S · CATHETER, RETENTION TYPE, BALLOON1 recall6 reports
- Porges Coloplast AB6024Coloplast A/S · CATHETER, RETENTION TYPE, BALLOON1 recall2 reports
- Porges Coloplast AB6A22Coloplast A/S · CATHETER, RETENTION TYPE, BALLOON1 recall2 reports
- Porges Coloplast AB6C20Coloplast A/S · CATHETER, RETENTION TYPE, BALLOON1 recall2 reports
- Porges Coloplast AB6C22Coloplast A/S · CATHETER, RETENTION TYPE, BALLOON1 recall2 reports
- Porges Coloplast AB6124Coloplast A/S · CATHETER, RETENTION TYPE, BALLOON1 recall1 report
- Porges Coloplast AB6220Coloplast A/S · CATHETER, RETENTION TYPE, BALLOON1 recall1 report
- Porges Coloplast AB6224Coloplast A/S · CATHETER, RETENTION TYPE, BALLOON1 recall1 report
- Porges Coloplast AB6420Coloplast A/S · CATHETER, RETENTION TYPE, BALLOON1 recall1 report
- Porges Coloplast AB6A24Coloplast A/S · CATHETER, RETENTION TYPE, BALLOON1 recall1 report
- Porges Coloplast AB6C18Coloplast A/S · CATHETER, RETENTION TYPE, BALLOON1 recall1 report
- Porges Coloplast AB6122Coloplast A/S · CATHETER, RETENTION TYPE, BALLOON1 recall0 reports
- Porges Coloplast AB6418Coloplast A/S · CATHETER, RETENTION TYPE, BALLOON1 recall0 reports
- Porges Coloplast AB6422Coloplast A/S · CATHETER, RETENTION TYPE, BALLOON1 recall0 reports
- Porges Coloplast AB6424Coloplast A/S · CATHETER, RETENTION TYPE, BALLOON1 recall0 reports
- Porges Coloplast AB6522Coloplast A/S · CATHETER, RETENTION TYPE, BALLOON1 recall0 reports
- Porges Coloplast AB6524Coloplast A/S · CATHETER, RETENTION TYPE, BALLOON1 recall0 reports
- Porges Coloplast AB6A18Coloplast A/S · CATHETER, RETENTION TYPE, BALLOON1 recall0 reports
- Porges Coloplast AB6A20Coloplast A/S · CATHETER, RETENTION TYPE, BALLOON1 recall0 reports
- Porges Coloplast AB6C24Coloplast A/S · CATHETER, RETENTION TYPE, BALLOON1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 95895).
- Z-0844-2025 · Open, ClassifiedFolysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124, AA6308, AA6310, AA6312, AA6314, AA6316, A…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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