Syringes & Needles recalls

1,060 medical device recalls in the syringes & needles category are on file with the FDA, from 2012 to 26 Aug 2026. The leading reason is sterility.

Total recalls1,060since 2012

Last 12 months81reported

Class I656% of total

Ongoing532latest 26 Aug 2026

Recalls per month, last 24 months

click a bar for that month

2Oct '24 10 1 3Jan '25 0 0 1Apr 4 3 2Jul 2 1 1Oct 25 1 0Jan '26 2 1 33Apr 4 0 12Jul 2 0

Severity split

Class I 65 6%Class II 978 92%Class III 17 2%

Why syringes & needles is recalled

Companies

Beaver Visitec International15915%
Jiangsu Shenli Medical Production Co878%
Becton Dickinson &777%
ICU Medical666%
International Medsurg Connection596%
Cardinal Health 200434%
Medline Industries373%
MEDLINE INDUSTRIES, LP - Northfield273%

By year

2026545%
2025434%
202432330%
2023404%
2022515%
2021575%
2020737%
2019777%
201810510%
2017929%

Ongoing syringes & needles recalls

532 active

Reported	Class	Recall	Company	Reason	Where
26 Aug 2026Device	CLASS I	BD Needle Kit for Powered Driver recalled by Bard Access Systems	Bard Access Systems	Other	32 states
19 Aug 2026Device	CLASS II	Boston Scientific Enhance Transcarotid/Peripheral Access Kit recalled	Galt Medical	Other	Nationwide
15 Jul 2026Device	CLASS II	Geneva Brachytherapy Applicator recalled by Elekta	Elekta	Other	Nationwide
15 Jul 2026Device	CLASS II	Brachytherapy Applicator Advanced Gynecological Applicator recalled	Elekta	Other	Nationwide
8 Jul 2026Device	CLASS II	Medline 111 Gravity Set W/3 Needle Free Y-Sites recalled	Bd Switzerland Sarl	Other	IL
8 Jul 2026Device	CLASS II	Syringe Luer Lok 10CC-200/Box BD Product recalled by Mentor Texas	Mentor Texas	Device Malfunction	CA, FL, PA

All syringes & needles recalls, newest first

1,060 total

Reported	Class	Recall	Company	Reason	Where
26 Aug 2026Device	CLASS I	BD Needle Kit for Powered Driver recalled by Bard Access Systems	Bard Access Systems	Other	32 states
19 Aug 2026Device	CLASS II	Boston Scientific Enhance Transcarotid/Peripheral Access Kit recalled	Galt Medical	Other	Nationwide
15 Jul 2026Device	CLASS II	Geneva Brachytherapy Applicator recalled by Elekta	Elekta	Other	Nationwide
15 Jul 2026Device	CLASS II	Brachytherapy Applicator Advanced Gynecological Applicator recalled	Elekta	Other	Nationwide
8 Jul 2026Device	CLASS II	Medline 111 Gravity Set W/3 Needle Free Y-Sites recalled	Bd Switzerland Sarl	Other	IL
8 Jul 2026Device	CLASS II	Syringe Luer Lok 10CC-200/Box BD Product recalled by Mentor Texas	Mentor Texas	Device Malfunction	CA, FL, PA
1 Jul 2026Device	CLASS II	Convenience kits containing select SKUs of Polycarbonate recalled	Medline Industries	Other	Nationwide
1 Jul 2026Device	CLASS II	Convenience kits containing select SKUs of Polycarbonate recalled	Medline Industries	Other	Nationwide
1 Jul 2026Device	CLASS II	Convenience kits containing select SKUs of Polycarbonate recalled	Medline Industries	Foreign Material	Nationwide
1 Jul 2026Device	CLASS II	Convenience kits containing select SKUs of Polycarbonate recalled	Medline Industries	Other	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.