Data / Medical devices / United States / Embecta Medical II LLC
Embecta Medical II LLC: FDA-registered device maker in Parsippany, NJ, United States, 14 510(k) clearances
Embecta Medical II LLC is registered with the FDA (registration 3022699058) in Parsippany, NJ, United States. It lists 3 device types. The FDA files 14 510(k) clearances under its listings, the newest dated July 13, 2026. 2 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3022699058
- Address
- 300 Kimball Drive, Parsippany, NJ, United States, 07054
- Owner or operator
- embecta Corp. (10084714)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- October 18, 2022
- Registered through
- 2027
- Brand names listed
- BD BFI MAIL DISPOSAL SERVICE, BD Hypodermic Syringe, BD Nano 2nd Gen, BD Pen Needle, BD SafetyGlide, BD SafetyGlide Insulin Syringe, One Piece Sharps Collector, SafeClip
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Needle, Hypodermic, Single Lumen | FMI | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Syringe, Antistick | MEG | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 13, 2026 | K260208 | Ultra-Fine SAFETY Insulin Syringe | FMF | Substantially Equivalent | embecta Medical II, LLC | accessdata.fda.gov |
| December 28, 2022 | K223286 | BD AutoShield Duo Pen Needle | FMI | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| June 28, 2022 | K213478 | BD Pen Needle | FMI | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| March 9, 2022 | K212499 | BD Insulin Syringe (0.3mL) | FMF | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| November 19, 2021 | K212015 | BD Nano 2nd Gen Pen Needle | FMI | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| January 25, 2021 | K203453 | BD Hypodermic Syringe | FMF | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| October 21, 2019 | K190054 | BD Insulin Syringe | FMF | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| December 20, 2018 | K182320 | BD Contoured Base Pen Needle | FMI | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| December 9, 2016 | K162516 | BD Pen Needle | FMI | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| July 8, 2016 | K151870 | BD U-500 INSULIN SYRINGE | FMF | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| October 1, 1999 | K992734 | BECTON DICKINSON SYRINGE | MEG | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| November 28, 1994 | K943139 | B-D GUARDIAN ONE PIECE SHARPS COLLECTORS | FMI | Substantially Equivalent | Med-Safe Systems, Inc. | accessdata.fda.gov |
| November 7, 1994 | K943137 | B-D/BFI MAIL DISPOSAL SERVICE | FMI | Substantially Equivalent | Med-Safe Systems, Inc. | accessdata.fda.gov |
| October 31, 1994 | K943683 | B-D SAFE-CLIP | FMI | Substantially Equivalent | Becton Dickinson Consumer Products | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 18, 2024 | 94851 | Class II | Ongoing | BD Nano 2nd Gen Pen Needles 32G X 4mm (5-count sample contained in Patient Counseling Sample Toolbox -Catalog 6484755/Lot Number: 3750144)-Sterile, single use devices designed for the parenteral administration of a drug | BD Nano 2nd Gen Pen Needle was shipped close to or after the labeled expiration date of February 29, 2024. Using a device past its expiry sterility and integrity of the device cannot be guaranteed. | accessdata.fda.gov |
| July 26, 2023 | 99593 | Class II | Ongoing | EWO_02512 (Catalog number 320550) For Investigational Use Only Nano Pro Un-Cannulated Demo Samples Quantity 100 | Retrospectively reported: Pen needles labeled 'For Investigational Use Only' were inadvertently distributed as commercially marketed devices. | accessdata.fda.gov |
Compare with other makers
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Syringe, Antistick
- All makers of Syringe, Piston
Updated July 13, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.