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Lower risk Medical device recall · FDA · Published September 25, 2019

Aesculap Micro Needle Holder Recall: Incorrect Size Labeling

Aesculap recalls a surgical needle holder labeled as 200mm but actually 150mm. This size error may cause improper use during procedures. Affected units have product code MG524R.

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Contact the company

Recalling firmAesculap Implant Systems LLC3773 Corporate Pkwy · Center Valley, PA 18034-8217
✎ GovInfoNow plain-language explainer

Aesculap recalls a specific surgical needle holder that's incorrectly labeled as 200mm when it's actually 150mm. This size mismatch could lead to improper use during surgery if the wrong size is used. Read more at govinfonow.com/recall/66965-aesculap-micro-needle-holder-recall-incorrect-size-labeling.

Source Summary by GovInfoNow · govinfonow.com/recall/66965-aesculap-micro-needle-holder-recall-incorrect-size-labeling · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1383-2022

Cite this page

“Aesculap Micro Needle Holder Recall: Incorrect Size Labeling.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66965-aesculap-micro-needle-holder-recall-incorrect-size-labeling. Based on FDA recall #Z-1383-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1383-2022%22&limit=1).

Aesculap Implant Systems LLC recalled the AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM (product code MG524R) because it was incorrectly labeled as 200mm when the actual size is 150mm, according to the FDA. The Food and Drug Administration announced the voluntary Class II recall on September 25, 2019.

How to tell if you have it

  • Brand: Aesculap
  • Product: AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM
  • Product code: MG524R
  • UDI-DI (GTIN): 04046955063277
  • Quantity: 7 pieces
  • Distribution: United States (TX and AK)

The hazard

The manual surgical instrument designed to grasp a suture needle was labeled with an incorrect length, posing a risk of using the wrong size instrument during surgery.

Context

GovInfoNow's records show Aesculap Implant Systems LLC has issued 26 other recalls since August 10, 2017. Recent recalls include a March 21, 2023 recall of the Caiman Articulating D5/360MM for a potential spring failure and a May 18, 2023 recall of surgical needles for incorrect product codes. Other recent recalls of similar products include a January 15, 2026 recall of the MINOP Trocar 150mm for a potentially too-long shaft and a June 25, 2026 recall of the Micro Therapeutics Pipeline Flex Embolization Device for incorrect diameter labeling.

How to tell if you have this one

Check for the product code MG524R on the needle holder. The item is labeled as 200mm but is actually 150mm in size.

  • Brand
    Aescul: Aesculap Implant Systems LLC
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Label

    Look for the product code MG524R on the needle holder to confirm it is affected.

Where it went and when

Where it was distributed

Distributed in Alaska and Texas.

Alaska: yesAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: yesTXFlorida: not listedFL

FDA distribution: “United States: TX and AK” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alaska, Texas.

Recall timeline

FDA terminated this recall 4.5 years after the firm started it.

1. Firm started the recall: Sep 25, 201912. FDA classified it Class II: Jul 13, 202223. Published in FDA’s Enforcement Report: Jul 20, 202234. FDA terminated the recall: Apr 1, 2024420192024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1383-2022 (September 25, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1383-2022 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA