Hazard Type

Sterility Issue Recalls

10,814 product recalls involving sterility issue. Search official CPSC, FDA, and USDA datasets for every recall issued due to this hazard.

10,814Total Recalls
297Critical
67933.1MUnits Affected
All Recalls

Every Sterility Issue Recall

Sorted by most recent. Click any recall for full details and safety information.

10,814 recalls
High RiskFDA
Prorx Llc
Semaglutide Injection, 12.5/5mL (2.5 mg/mL), 5mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA...
Injectable Drugs·2,809 affected·Oct 15, 2025
High RiskFDA
Prorx Llc
Semaglutide Injection, 5 mg/2 mL (2.5 mg/mL), 2mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, P...
Injectable Drugs·2,805 affected·Oct 15, 2025
High RiskFDA
Farmakeio Outsourcing Llc
Testosterone / Triamcinolone Acetonide 25MG/5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Ki...
Drugs·36,924 affected·Oct 14, 2025
High RiskFDA
Farmakeio Outsourcing Llc
Testosterone 50MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, ...
Drugs·829 affected·Oct 14, 2025
High RiskFDA
Farmakeio Outsourcing Llc
Testosterone 62.5 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlak...
Drugs·829 affected·Oct 14, 2025
High RiskFDA
Farmakeio Outsourcing Llc
Testosterone / Triamcinolone Acetonide Pellet (100MG/20MCG), 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcin...
Drugs·103,444 affected·Oct 14, 2025
High RiskFDA
Farmakeio Outsourcing Llc
Testosterone / Triamcinolone Acetonide, 12.5MG/2.5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920...
Drugs·18,124 affected·Oct 14, 2025
High RiskFDA
Farmakeio Outsourcing Llc
Testosterone / Triamcinolone Acetonide Pellet (37.5MG/7.5MCG), 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourc...
Drugs·43,424 affected·Oct 14, 2025
High RiskFDA
Farmakeio Outsourcing Llc
Testosterone 25MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, ...
Drugs·1,329 affected·Oct 14, 2025
High RiskFDA
Farmakeio Outsourcing Llc
Testosterone / Triamcinolone Acetonide Pellet (200MG/40MCG), 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcin...
Drugs·264,664 affected·Oct 14, 2025
High RiskFDA
Farmakeio Outsourcing Llc
Testosterone / Triamcinolone Acetonide 87.5MG/17.5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920...
Drugs·21,324 affected·Oct 14, 2025
High RiskFDA
Farmakeio Outsourcing Llc
Testosterone Regular Release 50 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste...
Drugs·4,829 affected·Oct 14, 2025
High RiskFDA
Farmakeio Outsourcing Llc
Testosterone / Triamcinolone Acetonide 50MG/10MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S K...
Drugs·64,924 affected·Oct 14, 2025
High RiskFDA
Farmakeio Outsourcing Llc
Testosterone 200 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake...
Drugs·4,929 affected·Oct 14, 2025
High RiskFDA
Farmakeio Outsourcing Llc
Testosterone / Triamcinolone Acetonide, 62.5MG/12.5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 92...
Drugs·31,124 affected·Oct 14, 2025
High RiskFDA
Farmakeio Outsourcing Llc
Testosterone Regular Release 200 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, St...
Drugs·14,329 affected·Oct 14, 2025
High RiskFDA
Farmakeio Outsourcing Llc
Testosterone 87.5 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlak...
Drugs·529 affected·Oct 14, 2025
CriticalFDA
Tmj Solutions Inc
TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only
Medical Implants·63 affected·Oct 13, 2025
High RiskFDA
Safecor Health, Llc
Haloperidol Lactate Injection, 5 mg/mL, 25 x 1 mL Single-Dose Vials, Sterile, Rx only, For Intramuscular Use Only, Manufactured for: Myl...
Injectable Drugs·800 affected·Oct 10, 2025
High RiskFDA
Samsung Bioepis Co., Ltd.
HADLIMA (adalimumab-bwwd) injection, 40mg/0.8 mL, 2 Single-dose Prefilled Syringes per carton, Rx only, Manufactured for: Organon LLC, a ...
Injectable Drugs·5,518 affected·Oct 10, 2025
High RiskFDA
Astrazeneca Pharmaceuticals
Fasenra (benralizumab) Injection, 30 mg/mL, one single-dose pre-filled syringe, Rx only, Manufactured by: AstraZeneca AB, Sweden, Distrib...
Injectable Drugs·916 affected·Oct 8, 2025
High RiskFDA
Sterilmed, Inc.
Brand Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Product Name: CATHETER ACUNAV DIAGNOSTIC U...
Surgical Devices·6 affected·Oct 8, 2025
High RiskFDA
Olympus Corporation Of The Americas
Brand Name: Olympus Single Use Single Use Electrosurgical Snare SD-400 Product Name: Single Use Single Use Electrosurgical Snare Model/...
Surgical Devices·18,174 affected·Oct 6, 2025
High RiskFDA
Alcon Research Llc
Alcon PRECISION1 One-Day Contact Lenses, -2.25D.
Medical Devices·82 affected·Sep 30, 2025
High RiskFDA
Sv Labs Prescott Corporation
Aloe Up Sport Performance Sunscreen Lotion SPF 30, 1 FL OZ (30 mL) per tube, Mfd. for: ALOE UP, 9700 W. 76th St., Ste 112, Eden Prairie, ...
Drugs·11,386 affected·Sep 25, 2025
CriticalFDA
Balt Usa, Llc
Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: MEGABT09180, MEGABT09190, MEGABT091100...
Medical Devices·207 affected·Sep 25, 2025
High RiskFDA
Total Joint Orthopedics, Inc.
Brand Name: Klassic BiPolar Head Model/Catalog Number: 3205.41.022 Klassic BiPolar Head, 41 mm OD, 22 mm Head; 3205.42.022 Klassic ...
Medical Devices·103 affected·Sep 23, 2025
High RiskFDA
Rc Outsourcing, Llc
Bevacizumab 1.75 mg/0.07 mL - 0.25 mL syringe, Intravitreal, 0.07 mL Total Volume, Rx Only, Hospital/Office Use Only, Refrigerate, RC Out...
Drugs·2,669 affected·Sep 22, 2025
High RiskFDA
Cpm Medical Consultants, Llc.
Fuse ULTRA Foot Plating System Instructions for Use. Models: OS200400, OS200401, OS328017, OS200020L, OS200025L, OS200120L, OS200125, ...
Medical Devices·3,317 affected·Sep 17, 2025
High RiskFDA
Biopro, Inc.
BioPro Bipolar Head Product ID/Description 18130 BIPOLAR HEAD 38MM 18131 BIPOLAR HEAD 39MM 18132 BIPOLAR HEAD 40MM 18133 BIPOLAR H...
Medical Devices·147 affected·Sep 9, 2025
High RiskFDA
Biopro, Inc.
BioPro Femoral Head (Metal 22, 28, 32, 36, 40) cobalt chromium and ceramic heads Part ID/Description: 18593 HEAD FEMORAL 22MM -3 185...
Medical Devices·147 affected·Sep 9, 2025
High RiskFDA
Icu Medical, Inc.
ICU Medical ChemoLock" Port, Bulk, Non-Sterile REF: CL2100-NS
Medical Devices·2,000 affected·Sep 8, 2025
High RiskFDA
Iantrek Inc.
C-Rex UNO Microinterventional Goniotomy Instrument. Model Number: CRX-120. Product Description: The C-Rex UNO Microinterventional Gon...
Surgical Devices·198 affected·Sep 6, 2025
High RiskFDA
Iantrek Inc.
Cyclopen Microinterventional Cyclodialysis System. Model Number: CP-300. Product Description: The CycloPen Microinterventional Cyclodi...
Surgical Devices·1,262 affected·Sep 6, 2025
High RiskFDA
Apotex Corp.
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, a) 5 mL and b) 10 mL, Rx Only, Sterile, Manufactured by: Apotex Inc....
Ophthalmic Drugs·151,034 affected·Sep 5, 2025
High RiskFDA
Apotex Corp.
Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, Ontario, Canada, L...
Ophthalmic Drugs·493,468 affected·Sep 5, 2025
High RiskFDA
Sandoz Inc
Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL), Hazardous Drug, Rx Only, Sterile, 5mL Multiple Dose Vial, Manufactured in Austria by ...
Injectable Drugs·6 affected·Sep 5, 2025
High RiskFDA
American Contract Systems Inc.
Medical convenience kits Item Number/Description HSAN63N ANGIO PACK IHAN02W ANGIOGRAPHY PACK MHCA98AK CORONARY ANGIO PACK- 205991 ...
Medical Devices·32,433 affected·Sep 4, 2025
High RiskFDA
American Contract Systems Inc.
Medical convenience kits Item Number/Description BFCT04X CATARACT PACK - 205986 CMEY17AI EYE PACK - 213187 CMEY17AI EYE PACK - 213...
Medical Devices·32,433 affected·Sep 4, 2025
High RiskFDA
American Contract Systems Inc.
Medical convenience kits Item Number/Description BUCY78E CYSTO PACK CMCP10X CYSTO PACK - 205972 IHCY10Y CYSTO PACK MHCY35AE CYSTO...
Medical Devices·32,433 affected·Sep 4, 2025
High RiskFDA
American Contract Systems Inc.
Medical convenience kits Item number/ Product description AHLD15X LABOR DELIVERY PACK - 213387 AKDV96B VAGINAL DELIVERY AKDV96B VA...
Medical Devices·32,433 affected·Sep 4, 2025
High RiskFDA
American Contract Systems Inc.
Medical convenience kits IHDC30R D AND C PACK
Medical Devices·32,433 affected·Sep 4, 2025
High RiskFDA
American Contract Systems Inc.
Basic Biopsy Tray, Item Number NMBP44L
Medical Devices·32,433 affected·Sep 4, 2025
High RiskFDA
American Contract Systems Inc.
Medical convenience kits Item Number/Description ANSH14AF SHOULDER PACK - 205962 EVAH76H ANTERIOR HIP PACK FDSA15M SHOULDER ARTHRO...
Medical Devices·32,433 affected·Sep 4, 2025
High RiskFDA
American Contract Systems Inc.
Basic Biopsy Tray; Item Number/Description: AKRB26D ROBOTIC, AMGL09AA GENERAL LAPAROSCOPY, ANLC35AD LAP CHOLE PACK - 205956, ANLP...
Medical Devices·32,433 affected·Sep 4, 2025
High RiskFDA
Fagron Compounding Services
bevacizumab (Avastin) Injection, 1.25mg/0.05mL (0.12 mL Fill), Sterile Single-Dose Syringe, Fagron Sterile Services, 8710 E 34th St N. Wi...
Injectable Drugs·109,320 affected·Aug 29, 2025
High RiskFDA
Northeast Scientific Inc.
NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-156. The NES Reprocessed Turbo-Elite Laser Athere...
Surgical Devices·616 affected·Aug 29, 2025
High RiskFDA
Northeast Scientific Inc.
NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-006. The NES Reprocessed Turbo-Elite Laser Ather...
Surgical Devices·199 affected·Aug 29, 2025