Henke-Ject-2 Sterile Syringes Recalled for Potential Sterile Barrier Damage
Wolf, Henke Sass is recalling Henke-Ject-2 single-use sterile syringes due to potential damage to the sterile barrier that could compromise product sterility. Approximately 216,000 units are affected across the US and Canada.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II device recall. Sterile barrier damage poses risk to device sterility. No illnesses or injuries reported. Meets rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Wolf, Henke Sass is recalling Henke-Ject-2 part luer sterile single-use syringes (UDI-DI: 04035873062004 and 04035873061991, Lots 22M28C8 and 23A09C8) because the sterile barrier may be damaged, potentially compromising the sterility of the device. These syringes are used for intravenous, intramuscular, subcutaneous, intracutaneous, and intraarterial injection of liquids or diluted drugs, and for withdrawal of fluids from the body.
Approximately 216,000 units have been distributed worldwide, including throughout the United States and Canada. Healthcare providers and patients who have syringes from the affected lots should consult with their healthcare provider regarding their use.
The recalled product
- Product
- Henke-Ject-2 part luer sterile single use syringes - used for intravenous, intramuscular, subcutaneous, intracutaneous and intraarterial injection of liquids or diluted drugs in combination with an adequate medical device or for withdrawal of fluids from the body. Ref…
- Manufacturer
- Wolf, Henke Sass, Gmbh
- Category
- Medical Device — Syringes
- Affected units
- 216,000
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: 04035873062004 and 04035873061991 Lot: 22M28C8 Lot: 23A09C8
Distribution
Distributed nationwide across the United States.
Related recalls
Same hazard · sterile barrier damage
See all →- HighCardiFocus Heartlight X3 Cardiac Catheter Sterile Barrier Damage Recall
FDA (Devices) · 2025-03-19
- HighDeRoyal Head and Neck Surgical Kits Recalled for Damaged Syringe Luer Tip
FDA (Devices) · 2023-10-25
Other medical device recalls
- HighFDA recalls injectable compounded mixture in single-use syringes
FDA (Drugs) · 2026-10-14
- ModerateBeckman Coulter DxC 500 AU Clinical Chemistry Analyzers Recalled for Software Error
FDA (Devices) · 2026-10-14
- LowMindray Recalls Passport Series Patient Monitor Operator's Manuals
FDA (Devices) · 2026-10-14
- SevereMedline Bariatric Rollator Recalled Due to Front Wheel Assembly Disconnect Risk
FDA (Devices) · 2026-10-14
- SevereSteris VERIFY Biological Steam Test Pack Recalled for Spore Population Defect
FDA (Devices) · 2026-10-14
Similar recalls
- HighB. Braun NORM-JECT Sterile Syringes Recalled Due to Packaging Damage
FDA (Devices) · 2023-10-04
- HighB.Braun NORM-JECT Luer Lock Solo 10ml Syringe Sterility Recall
FDA (Devices) · 2023-10-04
- HighMerit Medical StabiliT TOUCH Syringe Sterile Barrier Defect Recall
FDA (Devices) · 2024-10-23
- SevereMonoject Heparin Lock Flush Syringes Recalled for Non-Sterile Water Contamination
FDA (Devices) · 2013-09-18
- SevereMonoject Heparin Lock Flush Syringes Recalled for Potential Non-Sterile Water
FDA (Devices) · 2013-09-18
- HighMedline Contro-Bulb Syringe Recalled for Potential Sterile Barrier Breach
FDA (Devices) · 2024-09-25