Class II U.S. Food and Drug Administration

Nipro Medical Corporation Hemodialysis System, Surdial DX REF: MC+SDX01 recall: Screw may loosen or fallout of Hemodialysis system

Recall published 10 months ago

Screw may loosen or fallout of Hemodialysis system

The hazard: Device safety concern

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

What the notice says: Screw may loosen or fallout of Hemodialysis system

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-0912-2026
Published
December 17, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Nipro Medical Corporation
Product type
Medical devices
Units affected
N/A
Distribution
Nationwide
Made in
United States
Lot / code info
UDI: 00383790008815/Serial Numbers: 20EW0001 20EW0002 20EW0005 20EW0006 20EW0007 20EW0008 20EW0009 20EW0010 20EW0011 20EW0012 20EW0013 20EW0014 20EW0015 20EW0016 20EW0017 20EW0018 20EW0019 20EW0020 20EW0021 20EW0022 20EW0023 20EW0024 20EW0025 20EW0026 20EW0027 20EW0028 20EW0029 20EW0030 20EW0031 20EW0032 20EW0033 20EW0034 20EW0035 20EW0036 20EW0037 20EW0038 20EW0039 20EW0040 20EW0041 20EW0042 20EW0043 20EW0044 20EW0045 20EW0046 20EW0048 20EW0049 20EW0050 21EW0061 21EW0062 21EW0063 21EW0064 21EW0065 21EW0066 21EW0067 21EW0068 21EW0069 21EW0070 21EW0071 21EW0072 21EW0073 21EW0075 21EW0076 21EW0077 21EW0078 21EW0079 21EW0080 21EW0081 21EW0082 21EW0083 21EW0084 21EW0085 21EW0086 21EW0087 21EW0088 21EW0089 21EW0090 21EW0091 21EW0092 21EW0093 21EW0094 21EW0095 21EW0096 21EW0097 21EW0098 21EW0099 21EW0100 21EW0101 21EW0102 21EW0103 21EW0104 21EW0105 21EW0106 21EW0107 21EW0108 21EW0109 21EW0110 21EW0111 21EW0112 21EW0113 21EW0114 21EW0115 21EW0116 21EW0117 21EW0118 21EW0119 21EW0120 21EW0122 21EW0123 21EW0124 21EW0125 21EW0126 21EW0127 21EW0128 21EW0129 21EW0130 21EW0131 21EW0133 21EW0134 21EW0135 21EW0136 21EW0137 21EW0138 21EW0139 21EW0140 21EW0141 21EW0142 21EW0143 21EW0144 21EW0145 21EW0146 21EW0147 21EW0148 21EW0149 21EW0150 21EW0151 21EW0152 21EW0153 21EW0154 21EW0155 21EW0156 21EW0157 21EW0158 21EW0159 21EW0160 21EW0162 21EW0163 21EW0164 21EW0165 21EW0166 21EW0167 21EW0168 21EW0169 21EW0170 21EW0171 21EW0172 21EW0173 21EW0174 21EW0175 21EW0176 21EW0177 21EW0178 21EW0179 21EW0180 21EW0181 21EW0182 21EW0183 21EW0184 21EW0185 21EW0186 21EW0187 21EW0188 21EW0189 21EW0190 21EW0191 21EW0192 21EW0193 21EW0194 21EW0195 21EW0196 21EW0197 21EW0198 21EW0199 21EW0200 21EW0201 21EW0202 21EW0203 21EW0204 21EW0205 21EW0206 21EW0207 21EW0208 21EW0209 21EW0210 21EW0211 21EW0212 21EW0213 21EW0214 21EW0215 21EW0216 21EW0217 21EW0218 21EW0219 21EW0220 21EW0221 21EW0222 21EW0223 21EW0224 21EW0225 21EW0226 21EW0227 21EW0228 21EW0229 21EW0230 21EW0231 21EW0232 21EW0233 21EW0234 21EW0235 21EW0236 21EW0237 21EW0238 21EW0239 21EW0240 21EW0241 21EW0242 21EW0243 21EW0244 21EW0245 21EW0246 21EW0247 21EW0248 21EW0249 21EW0250 21EW0251 21EW0252 21EW0253 21EW0254 21EW0255 21EW0256 21EW0257 21EW0258 21EW0259 21EW0260 21EW0261 21EW0262 21EW0264 21EW0265 21EW0266 21EW0267 21EW0268 21EW0269 21EW0270 21EW0271 21EW0272 21EW0273 21EW0274 21EW0275 21EW0276 21EW0277 21EW0278 21EW0279 21EW0280 21EW0281 21EW0282 21EW0283 21EW0284 21EW0285 21EW0286 22EW0287 22EW0288 22EW0289 22EW0290 22EW0291 22EW0292 22EW0293 22EW0294 22EW0295 22EW0296 22EW0297 22EW0298 22EW0299 22EW0300 22EW0301 22EW0302 22EW0303 22EW0304 22EW0305 22EW0306 22EW0307 22EW0308 22EW0309 22EW0310 22EW0311 22EW0312 22EW0313 22EW0314 22EW0315 22EW0316 22EW0317 22EW0318 22EW0319 22EW0320 22EW0321 22EW0322 22EW0323 22EW0324 22EW0325 22EW0326 22EW0327 22EW0328 22EW0329 22EW0330 22EW0331 22EW0332 22EW0333 22EW0334 22EW0335 22EW0336 22EW0337 22EW0338 22EW0339 22EW0340 22EW0341 22EW0342 22EW0343 22EW0344 22EW0345 22EW0346 22EW0347 22EW0348 22EW0351 22EW0352 22EW0353 22EW0354 22EW0355 22EW0356 22EW0357 22EW0358 22EW0359 22EW0360 23EW0361 23EW0362 23EW0363 23EW0364 23EW0365 23EW0366 23EW0367 23EW0368 23EW0369 23EW0370 23EW0371 23EW0372 23EW0373 23EW0374 23EW0375 23EW0376 23EW0377 23EW0378 23EW0379 23EW0380 23EW0381 23EW0382 23EW0383 23EW0384 23EW0385 23EW0386 23EW0387 23EW0388 23EW0389 23EW0390 23EW0391 23EW0392 23EW0393 23EW0394 23EW0395 23EW0396 23EW0397 23EW0398 23EW0399 23EW0400 23EW0401 23EW0402 23EW0403 23EW0404 23EW0405 23EW0406 23EW0407 23EW0408 23EW0409 23EW0410 23EW0411 23EW0412 23EW0413 23EW0414 23EW0415 23EW0416 23EW0417 23EW0418 23EW0419 23EW0420 23EW0421 23EW0422 23EW0423 23EW0424 23EW0425 23EW0426 23EW0427 23EW0428 23EW0429 23EW0430 23EW0431 23EW0432 23EW0433 23EW0434 23EW0435 23EW0436 23EW0437 23EW0438 23EW0439 23EW0440 23EW0441 23EW0442 23EW0443 23EW0444 23EW0445 23EW0446 23EW0447 23EW0448 23EW0449 23EW0450 23EW0451 23EW0452 23EW0453 23EW0454 23EW0455 23EW0456 23EW0457 23EW0458 23EW0459 23EW0460 23E…
UPC codes
00383790008815

Products covered by this recall

Hemodialysis System, Surdial DX REF: MC+SDX01 Rx Only

Check your product

The notice names 2 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00383790008815

Model or item number

On the rating label, the box or the instruction sheet.

  • MC

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Nipro Medical Corporation — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Report device problems to the FDA through MedWatch.
  3. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  4. Ask the supplier or clinic that provided it what the remedy is in your case.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Company contact: Nipro Medical Corporation — 3150 NW 107th Ave, Doral, FL, 33172-2135

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Nipro Medical Corporation medical devices recalled?

Screw may loosen or fallout of Hemodialysis system Screw may loosen or fallout of Hemodialysis system

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00383790008815; model number MC. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Where was the recalled product sold?

It was distributed nationwide.

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