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Lower risk Medical device recall · FDA · Published May 18, 2023

Aesculap Surgical Needle Recall: Incorrect Product Code Risk

Aesculap recalls surgical needles with incorrect product code MD611 instead of MD610. This may cause confusion in medical use. Affected needles have specific model numbers and lot details.

🇺🇸 FDA recall #Z-2146-2023Medical deviceAesculap ›
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Recalling firmAesculap Implant Systems LLC3773 Corporate Pkwy · Center Valley, PA 18034-8217
✎ GovInfoNow plain-language explainer

What happened, in plain English

Aesculap is recalling surgical needles that have the wrong product code (MD611) instead of the correct code (MD610). This could lead to confusion in medical settings, potentially affecting patient safety. Read more at govinfonow.com/recall/58225-aesculap-surgical-needle-recall-incorrect-product-code-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/58225-aesculap-surgical-needle-recall-incorrect-product-code-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2146-2023

Cite this page

“Aesculap Surgical Needle Recall: Incorrect Product Code Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58225-aesculap-surgical-needle-recall-incorrect-product-code-risk. Based on FDA recall #Z-2146-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2146-2023%22&limit=1).

Why it’s dangerous

The needles are labeled with the incorrect product code (MD611) instead of the correct code (MD610). This could cause confusion during medical procedures, especially if the wrong needle is used in a critical situation. However, the needles are non-sterile and reusable, so the risk is primarily about identification errors rather than immediate harm.

Who’s affected

Surgical professionals and hospitals using the recalled needles. Patients are at low risk since the needles are non-sterile and reusable, but proper identification is critical.

How to tell if you have this one

Check for product code MD611 on the needle. The correct product code is MD610. Affected needles have a specific lot number (22002834) and GUIDID (04046963469054).

  • Brand
    Aesculap
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Code

    Verify the product code on the needle; it should be MD610, not MD611.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 3 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: nationwideOHPennsylvania: named in the noticePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: nationwideCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: named in the noticeMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: named in the noticeDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: named in the noticeTXFlorida: nationwideFL

FDA distribution: “US Nationwide distribution in the states of DC, MO, PA, TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: District of Columbia, Missouri, Pennsylvania, Texas.

Recall timeline

FDA published this recall 2 months after the firm started it.

1. Firm started the recall: May 18, 202312. FDA classified it Class II: Jul 14, 202323. Published in FDA’s Enforcement Report: Jul 26, 202332023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

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-2146-2023 (May 18, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2146-2023 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