Sterility recalls

15,581 recalls have been issued for sterility, from 2012 to 9 Sep 2026. 567 of them came in the last 12 months. 1,257 were classified Class I.

Total recalls15,581since 2012
Last 12 months567reported
Class I1,2578% of total
Ongoing2,997latest 9 Sep 2026

Recalls per month, last 24 months

click a bar for that month

Severity split

Class I 1,257 8%Class II 14,206 91%Class III 118 1%

Why sterility is recalled

Companies

Product types

Brands

By year

Ongoing sterility recalls

2,997 active
ReportedClassRecallCompanyReasonWhere
DeviceCLASS IIMedline Convenience Kits: Blood Draw Kit recalled by Medline IndustriesMedline IndustriesSterilityNationwide
DeviceCLASS IIMedline Convenience Kits: Ortho Aspiration Kit recalledMedline IndustriesSterilityNationwide
DeviceCLASS IINeuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalledAVID MedicalSterilityNationwide
DeviceCLASS IIMedline Convenience Kits: Arterial Line Insertion Kit recalledMedline IndustriesSterilityNationwide
DeviceCLASS IIMedline Convenience Kits: Colorectal ME recalled by Medline IndustriesMedline IndustriesSterilityNationwide
DeviceCLASS IIMedline Convenience Kits: Pre-op KIT recalled by Medline IndustriesMedline IndustriesSterilityNationwide

All sterility recalls, newest first

15,581 total
ReportedClassRecallCompanyReasonWhere
DeviceCLASS IIMedline Convenience Kits: Blood Draw Kit recalled by Medline IndustriesMedline IndustriesSterilityNationwide
DeviceCLASS IIMedline Convenience Kits: Ortho Aspiration Kit recalledMedline IndustriesSterilityNationwide
DeviceCLASS IINeuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalledAVID MedicalSterilityNationwide
DeviceCLASS IIMedline Convenience Kits: Arterial Line Insertion Kit recalledMedline IndustriesSterilityNationwide
DeviceCLASS IIMedline Convenience Kits: Colorectal ME recalled by Medline IndustriesMedline IndustriesSterilityNationwide
DeviceCLASS IIMedline Convenience Kits: Pre-op KIT recalled by Medline IndustriesMedline IndustriesSterilityNationwide
DeviceCLASS IIMedline Convenience Kits: Drawer 9 Cricothyrotomy Kit recalledMedline IndustriesSterilityNationwide
DeviceCLASS IIMedline Convenience Kits: Ivs Blood Culture Kit recalledMedline IndustriesSterilityNationwide
DeviceCLASS IIMedline Convenience Kits recalled by Medline IndustriesMedline IndustriesSterilityNationwide
DeviceCLASS IIMedline Convenience Kits: IV Start KIT recalled by Medline IndustriesMedline IndustriesSterilityNationwide

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.