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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/Surgical Equipment

Wolf, Henke Sass, Gmbh: Henke-Ject-2 Part Luer Sterile Syringes Recalled for Compromised Sterility

Agency Publication Date: September 27, 2023
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Summary

Wolf, Henke Sass, Gmbh has recalled approximately 216,000 Henke-Ject-2 part luer sterile single-use syringes because the sterile barrier packaging may be damaged. This defect means the syringes may no longer be sterile, which can lead to serious infections if used for injections or fluid withdrawal. These medical devices were distributed worldwide, including throughout the United States and Canada, between July 2023 and October 2023. If you have these syringes, you should contact your healthcare provider or the manufacturer immediately for instructions on how to handle the affected units.

Risk

A damaged sterile barrier allows bacteria and other contaminants to enter the syringe packaging, potentially causing life-threatening infections in patients receiving intravenous, intramuscular, or other types of injections.

What You Should Do

  1. Check your inventory for Henke-Ject-2 part luer sterile single use syringes with the reference number 4100.000V0.
  2. Verify if your products match UDI-DI codes 04035873062004 or 04035873061991 and Lot numbers 22M28C8 or 23A09C8.
  3. Immediately stop using any syringes identified as part of the recalled lots to avoid the risk of infection.
  4. Contact your healthcare provider or the manufacturer, Wolf, Henke Sass, Gmbh, for further instructions on returning or replacing the compromised devices.
  5. Call the FDA's medical device recall line at 1-888-463-6332 (1-888-INFO-FDA) if you have additional questions or concerns.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer consultation

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Henke-Ject-2 part luer sterile single use syringes
Model / REF:
4100.000V0
UPC Codes:
04035873062004
04035873061991
Lot Numbers:
22M28C8
23A09C8

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92836
Status: Active
Manufacturer: Wolf, Henke Sass, Gmbh
Sold By: authorized medical distributors
Manufactured In: Germany
Units Affected: 216,000
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 ยท 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.