Sterility recalls

13,729 recalls have been issued for sterility, from 2012 to 21 Oct 2026. 545 of them came in the last 12 months. 1,270 were classified Class I.

Total recalls13,729since 2012

Last 12 months545reported

Class I1,2709% of total

Ongoing2,639latest 21 Oct 2026

Recalls per month, last 24 months

click a bar for that month

17Nov '24 9 88 15Feb 50 79 34May 29 60 7Aug 28 105 21Nov 12 4 59Feb 19 56 104May 67 70 32Aug 56 45

Severity split

Class I 1,270 9%Class II 12,424 90%Class III 35 0%

Why sterility is recalled

Sterility13,729100%

Companies

Customed6825%
King Bio4653%
The Compounding Pharmacy of America3833%
Medline Industries LP - Northfield3813%
Central Admixture Pharmacy Services3443%
Windstone Medical Packaging3112%
Stryker Endoscopy2302%
Resource Optimization & Innovation2242%

Product types

Brands

By year

20265124%
20255284%
20245514%
20239547%
20226525%
20216785%
20206645%
20191,86914%
20188666%
20171,1538%

Ongoing sterility recalls

2,639 active

Reported	Class	Recall	Company	Reason	Where
21 Oct 2026Device	CLASS II	TS Misc. Instruments Tray, Triathlon recalled by Howmedica Osteonics	Howmedica Osteonics	Sterility	NJ
21 Oct 2026Device	CLASS II	Forward Gunshot Wound Kit recalled by Integrated Medcraft	Integrated Medcraft	Sterility	Nationwide
21 Oct 2026Device	CLASS II	iFuse TORQ Implant System recalled by Si-bone	Si-bone	Sterility	Nationwide
21 Oct 2026Device	CLASS II	TS Femoral Prep Tray, Triathlon recalled by Howmedica Osteonics	Howmedica Osteonics	Sterility	NJ
21 Oct 2026Device	CLASS II	Triathlon Hinge Femoral Prep Tray recalled by Howmedica Osteonics	Howmedica Osteonics	Sterility	NJ
21 Oct 2026Device	CLASS II	TS Universal Baseplate Finishing Tray, Triathlon recalled	Howmedica Osteonics	Sterility	NJ

All sterility recalls, newest first

13,729 total

Reported	Class	Recall	Company	Reason	Where
21 Oct 2026Device	CLASS II	TS Misc. Instruments Tray, Triathlon recalled by Howmedica Osteonics	Howmedica Osteonics	Sterility	NJ
21 Oct 2026Device	CLASS II	Forward Gunshot Wound Kit recalled by Integrated Medcraft	Integrated Medcraft	Sterility	Nationwide
21 Oct 2026Device	CLASS II	iFuse TORQ Implant System recalled by Si-bone	Si-bone	Sterility	Nationwide
21 Oct 2026Device	CLASS II	TS Femoral Prep Tray, Triathlon recalled by Howmedica Osteonics	Howmedica Osteonics	Sterility	NJ
21 Oct 2026Device	CLASS II	Triathlon Hinge Femoral Prep Tray recalled by Howmedica Osteonics	Howmedica Osteonics	Sterility	NJ
21 Oct 2026Device	CLASS II	TS Universal Baseplate Finishing Tray, Triathlon recalled	Howmedica Osteonics	Sterility	NJ
21 Oct 2026Drug	CLASS II	Tirzepatide/Niacinamide vial (40 MG per Vial) Inj 20mg/2mg/mL recalled	Houston Rx	Sterility	Nationwide
14 Oct 2026Device	CLASS II	Verify Biological Steam Test Pack recalled by Steris	Steris	Sterility	Nationwide
14 Oct 2026Device	CLASS II	Verify Biological/Integrator Challenge Pack recalled by Steris	Steris	Sterility	Nationwide
14 Oct 2026Device	CLASS II	Verify Dual Species Self-Contained Biological Indicator recalled	Steris	Sterility	Nationwide
14 Oct 2026Device	CLASS II	Verify Dual Species Self-Contained Biological Indicator recalled	Steris	Sterility	Nationwide
14 Oct 2026Device	CLASS II	Verify Biological/Integrator Challenge Pack recalled by Steris	Steris	Sterility	Nationwide
14 Oct 2026Device	CLASS II	Verify Biological Steam Test Pack recalled by Steris	Steris	Sterility	Nationwide
14 Oct 2026Drug	CLASS II	Apothecary NAD+ Injection 200 mg/mL Sterile Multi-Dose Vial recalled	Apothecary Pharma	Sterility	Nationwide
14 Oct 2026Drug	CLASS II	Sterile Eye Drops Redness Relief (Glycerin recalledLeader Eye Drops Redness Relief	K.C. Pharmaceuticals	Sterility	Nationwide
14 Oct 2026Drug	CLASS II	Sermorelin Acetate 1 MG/ML Injectable recalled by Carolina Infusion	Carolina Infusion	Sterility	Nationwide
14 Oct 2026Drug	CLASS II	Semaglutide 3 MG/ML Injectable, . syringes recalled by Carolina Infusion	Carolina Infusion	Sterility	Nationwide
14 Oct 2026Drug	CLASS II	Semaglutide/cyanocobalamin 3/2 MG/ML Injectable recalled	Carolina Infusion	Sterility	Nationwide
14 Oct 2026Drug	CLASS II	Sterile EYE Drops AC (tetrahydrozoline HCl recalledGoodsense Eye Drops Irritation Relief	K.C. Pharmaceuticals	Sterility	Nationwide
14 Oct 2026Drug	CLASS II	Semaglutide/cyanocobalamin 9/2 MG/ML Injectable recalled	Carolina Infusion	Sterility	Nationwide
14 Oct 2026Drug	CLASS II	Artificial Tears Sterile Lubricant Eye Drops recalledLeader Artificial Tears 15 Ml	K.C. Pharmaceuticals	Sterility	Nationwide
14 Oct 2026Drug	CLASS II	Tirzepatide 26 MG/ML Injectable recalled by Carolina Infusion	Carolina Infusion	Sterility	Nationwide
14 Oct 2026Drug	CLASS II	Tirzepatide/cyanocobalamin 76/2 MG/ML Injectable recalled	Carolina Infusion	Sterility	Nationwide
14 Oct 2026Drug	CLASS II	Eye Drops Maximum, Redness Relief, Sterile recalledTarget Eye Drops Maximum Redness Relief Eye	K.C. Pharmaceuticals	Sterility	Nationwide
14 Oct 2026Drug	CLASS II	Tirzepatide/cyanocobalamin 64/2 MG/ML Injectable recalled	Carolina Infusion	Sterility	Nationwide
14 Oct 2026Drug	CLASS II	Sterile High Performance Ultra Lubricating Eye Drops recalledLeader Ultra Lubricating Eye Drops	K.C. Pharmaceuticals	Sterility	Nationwide
14 Oct 2026Drug	CLASS II	Tirzepatide/cyanocobalamin 85/2 MG/ML Injectable recalled	Carolina Infusion	Sterility	Nationwide
14 Oct 2026Drug	CLASS II	Tri-Mix (Papav/Phento/Alpros),30/2/20, injectable recalled	Carolina Infusion	Sterility	Nationwide
14 Oct 2026Drug	CLASS II	Tirzepatide Injection, 18mg/mL Sterile Multi-Dose Vial recalled	Apothecary Pharma	Sterility	Nationwide
14 Oct 2026Drug	CLASS II	Tri-Mix (Papav/Phento/Alpros), 30/1/40, injectable recalled	Carolina Infusion	Sterility	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.