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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices

Palindrome and MAHURKAR Catheters Recalled for Sterile Packaging Breach

Agency Publication Date: May 30, 2025
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Summary

Mozarc Medical US LLC has recalled approximately 95,938 hemodialysis catheters, including Palindrome Precision and MAHURKAR Chronic models. These catheters are medical devices used to provide access to a patient’s bloodstream for blood cleansing treatments. The recall was initiated because the sterile barrier of the packaging may be breached or compromised, potentially exposing the devices to contamination. No incidents or injuries have been reported to date regarding this issue.

Risk

If the sterile packaging is damaged or breached, the catheter can become contaminated with bacteria or other harmful pathogens. Using a contaminated catheter during dialysis treatments can lead to serious bloodstream infections or other health complications for the patient.

What You Should Do

  1. This recall affects Mozarc Medical Palindrome Precision (Sport Pack, HSI, SI, and H models) and MAHURKAR Chronic Hemodialysis Catheters with specific model and lot numbers.
  2. Check your medical facility's inventory for the affected catheters by identifying the model numbers, UDIs, and Lot/Serial numbers printed on the device label or packaging. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled devices immediately and quarantine any affected stock to prevent use.
  4. Contact Mozarc Medical US LLC or your medical device distributor to arrange for the return, replacement, or correction of the affected catheters.
  5. If you have further questions regarding this recall, call the FDA Consumer Complaint hotline at 1-888-463-6332.

Your Remedy Options

📋Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Palindrome Precision Chronic Hemodialysis Catheter Sport Pack
Variants: Radiopaque urethane catheter
Model / REF:
8888128450P
8888123404P
8888123410P
8888128454P
8888128460P
8888133500P
8888133504P
8888133510P
8888123400P
8888119360P
8888119370P
8888119364P
Serial Numbers (138):
240450106
240640172
240640173
240640180
240640210
240660013
240780122
240790012
240850175
240850176
241170007
241270012
241340007
241340289
241410006
241550024
241620025
241690028
241800007
241900044
241970039
242110216
242110217
242110218
242180246
242180247
242180248
242180253
242180254
2119700109
2130800058
2130800068
2130800101
2133500082
2133600117
2133700190
2200400069
2200400070
2200400086
2200400087
2203800224
2203800233
2203900155
2203900156
2203900206
2203900207
2204000093
2204000123
2204000124
2204000125
UDI:
A8845211578301
A8845211577701
A8845211578101
A8845211578401
A8845211578801
A8845211579001
A8845211579101
20884521157955
A8845211577601
A8845211576901
A8845211577401
A8845211577001

UPN 20884521157832, 20884521157771, 20884521157818, 20884521157849, 20884521157887, 20884521157900, 20884521157917, 10884521157767, 20884521157764, 20884521157696, 20884521157740, 20884521157702.

Product: Palindrome Precision HSI Chronic Hemodialysis Catheter Sport Pack
Variants: Radiopaque urethane catheter
Model / REF:
8888128459P
8888119369P
8888133509P
8888123409P
Serial Numbers:
2133600044
2201700104
2203300067
2228000065
2228000067
2228000077
2234800091
2234800133
2234800161
2301100103
2302500152
2302500153
2302500156
2302500158
2305300130
2318500118
2318500120
2318500143
2330300100
2330300102
2332700278
2332700279
2335200415
2335200416
2402400082
2402400083
2402400084
2405800231
2418000151
2424200129
2426300194
2427700220
UDI:
20884521157870
20884521157733
20884521157948
20884521157801
Product: Palindrome Precision SI Chronic Hemodialysis Catheter Sport Pack
Variants: Radiopaque urethane catheter
Model / REF:
8888133508P
8888123408P
8888119368P
8888128458P
Serial Numbers:
2234800132
2302500141
2302500148
2305300142
2305300144
2305300177
2313800083
2324100168
2324100310
2324100311
2405800229
2426300218
2426700122
2427700199
UDI:
20884521157931
20884521157795
20884521157726
20884521157863
Product: Palindrome Precision H Chronic Hemodialysis Catheter Sport Pack
Variants: Radiopaque urethane catheter
Model / REF:
8888123405P
8888123411P
8888128455P
8888128461P
8888119365P
8888119371P
8888133505P
Serial Numbers:
2204000102
2228000068
2228000070
2234800148
2234800159
2234800160
2302500128
2305300136
2315600104
2315600113
2315600119
2315600122
2318500135
2318500136
2318500140
2320000255
2332700275
2335200414
2412000238
2412000239
2414300228
2414300233
2418000150
2426300169
UDI:
20884521157788
20884521157825
20884521157856
20884521157894
20884521157719
10884521157750
20884521157924
Product: MAHURKAR Chronic Hemodialysis Catheter Sport Pack
Variants: Radiopaque urethane catheter
Model / REF:
8888133502
Serial Numbers:
241760200
UDI:
A8845210569201

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96809
Status: Active
Manufacturer: Mozarc Medical US LLC
Sold By: Hospital suppliers; Medical device distributors
Manufactured In: United States
Units Affected: 5 products (95,938 units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.