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Lower risk Medical device recall · FDA · Published September 14, 2021

Bayer MEDRAD Twist & Go Syringe Recall: Labeling Error Risk

Bayer recalls MEDRAD Twist & Go Disposable Syringes due to labeling error with Mark 7 Arterion system. Affected units may be misused if not properly identified. Contact for details.

🇺🇸 FDA recall #Z-0199-2022Medical deviceBayer Medical Care ›
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Recalling firmBayer Medical Care, Inc.1 Bayer Dr · Indianola, PA 15051-9702
✎ GovInfoNow plain-language explainer

Bayer is recalling MEDRAD Twist & Go Disposable Syringes (150 mL) because they are incorrectly labeled as part of the Mark 7 Arter:ion Injection System. This labeling error could lead to improper use if the syringe is not correctly identified with the right system. Read more at govinfonow.com/recall/61799-bayer-medrad-twist-go-syringe-recall-labeling-error-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/61799-bayer-medrad-twist-go-syringe-recall-labeling-error-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0199-2022

Cite this page

“Bayer MEDRAD Twist & Go Syringe Recall: Labeling Error Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61799-bayer-medrad-twist-go-syringe-recall-labeling-error-risk. Based on FDA recall #Z-0199-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0199-2022%22&limit=1).

Bayer Medical Care, Inc. recalled The MEDRAD Twist & Go Disposable Syringe 150 mL with Quick Fill Tube on Sept. 14, 2021, due to a labeling error that misidentified the product as a different syringe type, according to the FDA.

How to tell if you have it

  • Brand: Bayer Medical Care
  • Product: The MEDRAD Twist & Go Disposable Syringe 150 mL with Quick Fill Tube
  • Batch number: 8415317

The hazard

The syringes were labeled as MEDRAD Mark 7 Arterion Injection System Syringes (ART 700 SYR) instead of Twist & Go Syringes (TAG 150 SYR), according to the FDA.

Context

GovInfoNow's records show Bayer Medical Care, Inc. has issued seven other recalls since June 28, 2018. Other recent recalls of similar products include Omnicell i.v.Station Label Stock Recall (March 25, 2026), Medline TRACH TUBE KIT Recall (July 10, 2026) and Medline EYE TRAY-LF Kit Recall (April 10, 2026).

How to tell if you have this one

Check for the batch number 8415317 on the syringe. The syringe is part of the MEDRAD Mark 7 Arterion Injection System and is labeled as a Twist & Go Syringe (TAG 150 SYR).

  • Brand
    Bayer Medical Care
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Syringe Label

    Look for the batch number 8415317 on the syringe to confirm if it is affected.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Worldwide distribution - US Nationwide and the countries of AU, BY, DE, DK, GB, HR, NL, NZ, RU, SE, TH.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 16 months after the firm started it.

1. Firm started the recall: Sep 14, 202112. FDA classified it Class II: Nov 3, 202123. Published in FDA’s Enforcement Report: Nov 10, 202134. FDA terminated the recall: Jan 19, 2023420212023
  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-0199-2022 (September 14, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0199-2022 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