Skip to content

Monoject Safety Needle

by Tyco Healthcare 510(k)

Active United States

510(k) K012736

Overview

The Monoject Safety Needle is a hypodermic needle designed with a safety mechanism to protect healthcare workers from accidental sharps injuries. It features an intuitive, easy-to-use hinged safety device that can be activated with the push of a thumb.

This device is supplied as a preattached Safety Needle and Syringe Combination and is available in various sizes. It is intended for single-use and has received FDA 510(k) clearance with the product code FMI.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK012736 Date25 Oct 2001ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

93 recalls · FDA

    • Terminated Z-1252-2021 FDA Class II initiated 9 Feb 2021

    Safety shield not locking into the cannula. If the safety shield activation fails to lock a contaminated needle, a needlestick may occur and there is the potential for exposure to bloodborne pathogens

    • Terminated Z-0730-2008 FDA Unclassified (pre-2012) initiated 26 Oct 2007 via K012736, on the same 510(k)

    Incorrect Needle size - Some of the kits contain a 1 inch 21G needle instead of the 1-1/2 inch 21 needle specified on the kit label.

    • Terminated Z-0729-2008 FDA Unclassified (pre-2012) initiated 26 Oct 2007 via K012736, on the same 510(k)

    Incorrect Needle size - Some of the kits contain a 1 inch 21G needle instead of the 1-1/2 inch 21G needle specified on the kit label.

  • 90 recalls, same reason

    • Terminated Z-0137-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0117-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0085-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0129-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0097-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0146-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0124-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0073-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0147-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0108-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0072-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0070-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0128-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0102-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0112-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0150-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0074-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0078-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0095-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0100-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0103-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0113-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0118-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0144-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0153-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0092-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0148-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0089-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0081-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0152-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0088-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0131-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0111-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0076-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0090-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0065-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0140-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0110-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0101-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0075-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0114-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0136-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0106-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0143-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0149-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0116-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0066-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0125-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0093-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0087-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0079-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0151-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0145-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0127-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0154-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0141-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0086-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0132-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0105-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0068-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0133-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0069-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0142-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0135-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0098-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0138-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0064-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0091-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0080-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0084-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0139-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0120-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0104-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0121-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0119-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0134-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0130-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0099-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0115-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0094-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0126-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0107-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0082-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0123-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0077-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0122-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0067-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0109-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0071-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004
    • Terminated Z-0096-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004

    Needle cannula may separate from the hub during use

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

510(k)

510(k) Number
FDA Product Code
FMI
Device Class
Class II
Regulation
21 CFR Part 880.5570
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Other devices from Tyco Healthcare

See all devices from Tyco Healthcare →

Questions

  • What is the purpose of the Monoject Safety Needle?

    The Monoject Safety Needle is a hypodermic needle with a safety mechanism designed to protect healthcare workers from accidental sharps injuries. It features an intuitive hinged safety device that can be activated with a simple thumb push.

  • How is the Monoject Safety Needle supplied?

    The device is supplied as a preattached Safety Needle and Syringe Combination and is available in various sizes to accommodate different clinical needs.

  • Is the Monoject Safety Needle reusable or single-use?

    The Monoject Safety Needle is intended for single-use only, meaning it should be discarded after one use to ensure safety and prevent cross-contamination.

  • What regulatory clearance has the Monoject Safety Needle received?

    The Monoject Safety Needle has received FDA 510(k) clearance with the product code FMI, indicating it has been determined to be substantially equivalent to existing devices.