Syringes & Needles recalls

1,067 medical device recalls in the syringes & needles category are on file with the FDA, from 2012 to 21 Oct 2026.

Total recalls1,067since 2012

Last 12 months87reported

Class I656% of total

Ongoing539latest 21 Oct 2026

Recalls per month, last 24 months

click a bar for that month

10Nov '24 1 3 0Feb 0 1 4May 3 2 2Aug 1 1 25Nov 1 0 2Feb 1 33 4May 0 12 2Aug 5 2

Severity split

Class I 65 6%Class II 985 92%Class III 17 2%

Why syringes & needles is recalled

Companies

By year

2026616%
2025434%
202432330%
2023404%
2022515%
2021575%
2020737%
2019777%
201810510%
2017929%

Ongoing syringes & needles recalls

539 active

Reported	Class	Recall	Company	Reason	Where
21 Oct 2026Device	CLASS II	Williams Cystoscopic Injection Needles, used recalled by Cook	Cook	Device Malfunction	5 states
7 Oct 2026Device	CLASS II	Embosphere 500-700 micrometer Syringe Sterile Steam recalled	Merit Medical Systems	Sterility	Nationwide
23 Sep 2026Device	CLASS II	IV Sets with drip chambers recalled by ICU Medical	ICU Medical	Particulate Matter	Nationwide
23 Sep 2026Device	CLASS II	IV Sets with drip chambers recalled by ICU Medical	ICU Medical	Particulate Matter	Nationwide
23 Sep 2026Device	CLASS II	Medrad¿ Stellant Flex Syringe Kit used recalled by Bayer Medical Care	Bayer Medical Care	Sterility	Nationwide
23 Sep 2026Device	CLASS II	IV Sets with drip chambers recalled by ICU Medical	ICU Medical	Particulate Matter	Nationwide

All syringes & needles recalls, newest first

1,067 total

Reported	Class	Recall	Company	Reason	Where
21 Oct 2026Device	CLASS II	Williams Cystoscopic Injection Needles, used recalled by Cook	Cook	Device Malfunction	5 states
7 Oct 2026Device	CLASS II	Embosphere 500-700 micrometer Syringe Sterile Steam recalled	Merit Medical Systems	Sterility	Nationwide
23 Sep 2026Device	CLASS II	IV Sets with drip chambers recalled by ICU Medical	ICU Medical	Particulate Matter	Nationwide
23 Sep 2026Device	CLASS II	IV Sets with drip chambers recalled by ICU Medical	ICU Medical	Particulate Matter	Nationwide
23 Sep 2026Device	CLASS II	Medrad¿ Stellant Flex Syringe Kit used recalled by Bayer Medical Care	Bayer Medical Care	Sterility	Nationwide
23 Sep 2026Device	CLASS II	IV Sets with drip chambers recalled by ICU Medical	ICU Medical	Particulate Matter	Nationwide
23 Sep 2026Device	CLASS II	IV Sets with drip chambers recalled by ICU Medical	ICU Medical	Particulate Matter	Nationwide
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 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
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	Other	Nationwide
1 Jul 2026Device	CLASS II	Convenience kits containing select SKUs of Polycarbonate recalled	Medline Industries	Other	Nationwide
27 May 2026Device	CLASS II	Oncology Kit w/60" Appx, Smallbore Ext Set w/ChemoLock Port recalled	ICU Medical	Packaging Defects	Nationwide
20 May 2026Device	CLASS I	Custom Convenience Kit containing Medline Namic recalled	Windstone Medical Packaging	Other	Nationwide
20 May 2026Device	CLASS I	Rolls of label stock used with the Omnicell i.v.Station recalled	Omnicell	Labeling Errors	AL, MD, PA
13 May 2026Device	CLASS I	Convenience kits containing Medline Namic Angiographic recalled	American Contract Systems	Other	MN
29 Apr 2026Device	CLASS II	Medline Kits: Syr Control Rotating recalled by Medline Industries	Medline Industries	Other	Nationwide
29 Apr 2026Device	CLASS II	Medline Convenience Kits containing select SKUs recalled	Medline Industries	Other	Nationwide
29 Apr 2026Device	CLASS II	Medline Convenience Kits containing select SKUs recalled	Medline Industries	Other	Nationwide
29 Apr 2026Device	CLASS II	Medline Syringes: Syringe Control W/Rotator recalled	Medline Industries	Other	Nationwide
29 Apr 2026Device	CLASS II	Medline Convenience Kits containing select SKUs 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.