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
Medtronic Navigation, Inc.
Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150MM, STERILE PERCUTANEOUS REF: 97733236 The Sterile Percuta...
Medical Devices·67,370 affected·Dec 4, 2024
High RiskFDA
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE HEGAR DILATOR 11&12MM STRLCS25Model Number 96-0960; 2) ECONO STERI...
Medical Devices·75 affected·Dec 3, 2024
High RiskFDA
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE BACKHAUS TWL CLP STER 3.5 CS50, Model Number 96-2630; 2) ECONO STE...
Medical Devices·300 affected·Dec 3, 2024
High RiskFDA
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: ECONO STERILE" CURETTE EXCAVATOR STRL CS/25, Model Number 941-1320; general surgical
Surgical Devices·0 affected·Dec 3, 2024
High RiskFDA
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ROCH-PEAN FCP 8" CVD CS/25,Model Number 94-0286; 2) ECONO STERILE ...
Medical Devices·245,015 affected·Dec 3, 2024
High RiskFDA
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE SIMS UTERINE CURETTE #3 STER25, Model Number 96-4113; 2) ECONO STE...
Medical Devices·0 affected·Dec 3, 2024
High RiskFDA
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: ECONO STERILE TROUSSEAU DILATOR CS/25, Model Number 941-0191 (tracheal procedures)
Medical Devices·0 affected·Dec 3, 2024
High RiskFDA
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE VIENNA NSL SPEC MD STRL CS/25, Model Number 96-2236; 2) ECONO STER...
Medical Devices·175 affected·Dec 3, 2024
High RiskFDA
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: ECONO STERILE ALFONSO INFANT SPEC STRL CS/10, Model Number 96-3814; eyelid surgery
Medical Devices·0 affected·Dec 3, 2024
High RiskFDA
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE YANKAUER SUCTION TUBE 8.5" C10, Model Number 96-4176; 2) ECONO STE...
Medical Devices·150 affected·Dec 3, 2024
High RiskFDA
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE OLSEN-HEG NH SMO DEL 5.5STER25, Model Number 96-2352A; 2) ECONO S...
Medical Devices·41,850 affected·Dec 3, 2024
High RiskFDA
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: ECONO STERILE KOGAN ENDOCERV SPEC STER CS/5, Model Number 96-4142A, gynecological pro...
Medical Devices·40 affected·Dec 3, 2024
High RiskFDA
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE WEITLANER RETR SH 2X3 4.5"CS25, Model Numbers: 96-2201A; 2) ECONO...
Surgical Devices·75 affected·Dec 3, 2024
High RiskFDA
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE PROBE W/EYE CS/50, Model Number 94-5923; 2) ECONO STERIL" PROBE W/...
Medical Devices·2,500 affected·Dec 3, 2024
High RiskFDA
Sklar Instruments
ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE FREER ELEV DE S/B 7.25" CS/25, Model Number 96-2483 (multiple ...
Medical Devices·125 affected·Dec 3, 2024
High RiskFDA
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: ECONO STERILE LEMPERT BONE RONG 6.25" STER25, Model Number 96-4780A; orthopedic surgery
Medical Devices·0 affected·Dec 3, 2024
High RiskFDA
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ARMY RETR (SET OF 2) STER CS25, Model Number 96-2243; 2) ECONO STE...
Medical Devices·1,050 affected·Dec 3, 2024
High RiskFDA
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE GRAVES SPEC STRL SM BX/25, Model Number 96-2603; 2) ECONO STERIL...
Medical Devices·475 affected·Dec 3, 2024
High RiskFDA
Sklar Instruments
Medical procedure kits labeled as: 1) ECONO STERILE STRABIS SCISS STR 4.5"STER 50, Model Number 96-2540; 2) ECONO STERILE STRABIS SC...
Medical Devices·350 affected·Dec 3, 2024
High RiskFDA
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: ECONO STERILE SCALPEL HDL #3 W/METRIC CS/25, Model Number 96-3500M
Surgical Devices·150 affected·Dec 3, 2024
High RiskFDA
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE D/A NAIL NIPPER 5.75" STER CS5, Model Number 96-2424A; 2) ECONO ST...
Medical Devices·7,730 affected·Dec 3, 2024
High RiskFDA
Coloplast Manufacturing Us, Llc
X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB6122, AB6124, AB6220, AB6222, AB6224, AB6318, A...
Surgical Devices·36,369 affected·Dec 2, 2024
High RiskFDA
Microvention Inc.
Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx Only, Lot# 0000629846
Surgical Devices·107 affected·Dec 2, 2024
High RiskFDA
O&m Halyard, Inc.
Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Description: Laparotomy P...
Medical Devices·1,440 affected·Nov 26, 2024
High RiskFDA
Olympus Corporation Of The Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,35 cm, Front-actuated Grip Typ...
Surgical Devices·128,608 affected·Nov 25, 2024
High RiskFDA
Olympus Corporation Of The Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type...
Surgical Devices·112 affected·Nov 25, 2024
High RiskFDA
Olympus Corporation Of The Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Ty...
Surgical Devices·495,865 affected·Nov 25, 2024
High RiskFDA
Olympus Corporation Of The Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type...
Surgical Devices·4,055 affected·Nov 25, 2024
High RiskFDA
Olympus Corporation Of The Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Typ...
Surgical Devices·84,570 affected·Nov 25, 2024
High RiskFDA
Olympus Corporation Of The Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Typ...
Surgical Devices·36,712 affected·Nov 25, 2024
High RiskFDA
Olympus Corporation Of The Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type...
Surgical Devices·9,200 affected·Nov 25, 2024
High RiskFDA
Olympus Corporation Of The Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: Thunderbeat Front-Actuated Grip Type S Model N...
Surgical Devices·34,325 affected·Nov 25, 2024
High RiskFDA
Cook Biotech, Inc.
Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile; and
Medical Devices·6 affected·Nov 22, 2024
High RiskFDA
Cook Biotech, Inc.
Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile.
Medical Devices·49 affected·Nov 22, 2024
High RiskFDA
Cook Biotech, Inc.
Cook Medical Biodesign Dural Graft, REF C-DUR-7X10, REF G31091, Sterile
Medical Devices·10 affected·Nov 22, 2024
High RiskFDA
Med Michigan Holding Llc
SUC-4300S, Rigid Intracardiac Sucker Fluted Tip; 1/4" (6.4mm) connector 13" (33cm) length. Indicated for handheld use only to remove exce...
Cardiac Devices·109 affected·Nov 19, 2024
High RiskFDA
Aerin Medical, Inc.
Aerin Medical VivAer Stylus, REF CAT1785 (individual stylus), and REF CAT500 (5-pack), sterile.
Medical Devices·479 affected·Nov 12, 2024
High RiskFDA
Tailstorm Health Inc
BEVACIZUMAB (AVASTIN)1.25mg/0.05mL, Sterile Injection, 0.5 mL Single-Dose Syringe, Rx Only, Repackaged by: Medivant Healthcare: 24416 N 1...
Injectable Drugs·27,560 affected·Nov 6, 2024
High RiskFDA
Medline Industries, Lp - Northfield
KIT,SPINE LH Convenience kit, SKU DYNJ906448A.
Medical Devices·160 affected·Nov 6, 2024
High RiskFDA
Medline Industries, Lp - Northfield
SEPTOPLASTY PACK Convenient kit, SKU DYNJ44759F. Convenience kits used for various procedures.
Medical Devices·40 affected·Nov 6, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline brand, medical procedure convenience kits, labeled as: 1) CRANIOTOMY, SKU CDS982719X; 2) MVFF/FIBU #54-RF, SKU DYNJ21927Q; 3) MVF...
Medical Devices·0 affected·Nov 6, 2024
High RiskFDA
Medline Industries, Lp - Northfield
DIEP FLAP Convenience kit, SKU DYNJ910120. Convenience kits used for various procedures.
Medical Devices·26 affected·Nov 6, 2024
High RiskFDA
Medline Industries, Lp - Northfield
FESS-MB PACK-LF Convenience kit, SKU DYNJ0888159I. Convenience kits used for various procedures..
Medical Devices·36 affected·Nov 6, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline brand, medical procedure convenience kits, labeled as: 1) MVFF/FIBU #54-RF , SKU DYNJ21927R; 2) DIEP FLAP, SKU DYNJ910120A
Medical Devices·318 affected·Nov 6, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline brand, medical procedure convenience kits, labeled as: 1) SINUS CDS-1, SKU CDS982901F; 2) NASAL PACK, SKU DYNJ17493G; 3) FESS PAC...
Medical Devices·6,467 affected·Nov 6, 2024
High RiskFDA
Fdc Limited
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtr...
Ophthalmic Drugs·155,232 affected·Oct 29, 2024
High RiskFDA
Smith & Nephew Inc.
BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.
Medical Devices·2,156 affected·Oct 29, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Lab Kit, SKU DYLAB1018; Component No. 503581
Medical Devices·626,305 affected·Oct 23, 2024