Lower riskMedical device recall · FDA · Published August 7, 2023
B. Braun NORM-JECT Luer Lock Solo 10ml: Sterility Risk in Packaging
B. Braun recalls 10ml sterile NORM-JECT Luer Lock Solo syringes due to potential packaging damage that could compromise sterility. Affected units include specific lot numbers and distribution dates.
“B. Braun NORM-JECT Luer Lock Solo 10ml: Sterility Risk in Packaging.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57525-b-braun-norm-ject-luer-lock-solo-10ml-sterility-risk. Based on FDA recall #Z-2644-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2644-2023%22&limit=1).
B. Braun Medical, Inc. recalled B.Braun NORM-JECT Luer Lock Solo syringes on Aug. 7, 2023, due to compromised sterility from damaged blister packaging, according to the FDA. The agency announced the voluntary Class II recall affecting 604,800 units distributed nationwide.
The sterile blister packaging may be damaged, and sterility may be compromised. The syringes are intended to deliver or withdraw an accurate metered dose of fluid.
Context
GovInfoNow's records show B Braun Medical Inc has issued 66 other recalls since Oct. 15, 2013. Recent recalls include a 2026-08-19 recall for particulate matter in 100mL Sodium Chloride Injection and a 2026-08-12 recall for particulate matter in Lactated Ringer's Injection. Other recent recalls of similar products include Medline Convenience Kits recalls dated 2026-06-12.
How to tell if you have this one
Check for the lot numbers 22M21C8 or 23A09C8 on the packaging. The product is a 10ml sterile syringe labeled for delivering or withdrawing fluid from the body.
Brand
B. Braun
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
US Nationwide distribution in the state of VA.
Recall number
Product, codes & lots
Quantity
Z-2643-2023
B. Braun NORM-JECT Luer Solo, 10 ml, Sterile-Intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. Distributed by: Air-Tite Products Co., Inc, 565 Central Drive, Virginia Beach, VA 23454. REF: NJ-4606108-02; UDI-DI: 04046955597031 Lot Numbers: 22M28C8, 23A09C8
534,000 units
Z-2644-2023
B.Braun NORM-JECT Luer Lock Solo, 10 ml, Sterile-Intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. Distributed by: Air-Tite Products Co., Inc, 565 Central Drive, Virginia Beach, VA 23454. REF: NJ-4606728-02; UDI-DI: 04046955597185 Lot Numbers: 22M21C8, 23A09C8
604,800 units
Based on the official FDA remedy
What to do — step by step
Check Packaging
Look for the lot numbers 22M21C8 or 23A09C8 on the syringe packaging.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution in the state of VA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 58 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-2644-2023 (August 7, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2644-2023 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.