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
Globus Medical, Inc.
Globus Medical Cranial Drill with Stop, 3.20mm - instruments for access, preparation, and placement of cranial devices with the Excelsiu...
Medical Devices·0 affected·Dec 11, 2023
CriticalFDA
Cardinal Health 200, Llc
Dover" IRRIGATION 1200 CC TRAY, 60 CC PISTON SYRINGE, STERILE SALINE, TIP PROTECTOR, ALCOHOL, LIDDED
Medical Devices·63,360 affected·Dec 4, 2023
CriticalFDA
Cardinal Health 200, Llc
Argyle" Suction Catheter Tray with Chimney Valve Sterile Saline 18 Fr/Ch (6.0mm); Argyle" Suction Catheter Tray with Chimney Valve Steril...
Surgical Devices·25,896 affected·Dec 4, 2023
High RiskFDA
American Contract Systems, Inc.
Procedural convenience kits and trays, cardiac, labeled as: a) EP LAB BI V IMPLANT PACK, kit number AGBI64J; b) LAB DEVICE IMPLANT, ...
Medical Implants·12,291 affected·Nov 29, 2023
High RiskFDA
American Contract Systems, Inc.
Custom procedural convenience kits and trays, ear, nose & throat, labeled as: a) T AND A PACK AGH ASC, kit number AGTA48J; b) OPSC E...
Medical Devices·804 affected·Nov 29, 2023
High RiskFDA
American Contract Systems, Inc.
Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LavH, kit number BBLV21C; b) LAP HYST ...
Medical Devices·144 affected·Nov 29, 2023
High RiskFDA
American Contract Systems, Inc.
Custom procedural convenience kits and trays, cardiac, labeled as: a) CENTRAL LINE INSERTION PACK, kit number LLCE52; b) Adult Centr...
Cardiac Devices·290 affected·Nov 29, 2023
High RiskFDA
American Contract Systems, Inc.
Custom procedural convenience kits and trays, general & plastic surgery, labeled as: a) BRACHY THERAPY PROCEDURE PAC, kit number AGBR9...
Medical Devices·7,881 affected·Nov 29, 2023
High RiskFDA
American Contract Systems, Inc.
Custom procedural convenience kits and trays, gastroenterological & urological, labeled as: a) LAP KIDNEY MODULE, kit number AGKD50L; ...
Medical Devices·3,196 affected·Nov 29, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 (Eclipse gown), REF SPT-2208CS, 100/pack, Non-Sterile.
Medical Devices·2,100 affected·Nov 29, 2023
High RiskFDA
American Contract Systems, Inc.
Custom procedural convenience kits and trays, general hospital use, labeled as: a) Baby PICC Kit, kit number UIBP90J; b) Baby PICC K...
Medical Devices·244 affected·Nov 29, 2023
High RiskFDA
American Contract Systems, Inc.
Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LOWER PELVIC PACK, kit number AGLP52L; ...
Medical Devices·1,020 affected·Nov 29, 2023
High RiskFDA
Medtronic Navigation, Inc.
Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS
Medical Devices·4,235 affected·Nov 28, 2023
High RiskFDA
Medtronic Navigation, Inc.
Medtronic, REF 9733236, Pin, 150mm, STERILE, PERCUTANEOUS
Medical Devices·4,224 affected·Nov 28, 2023
High RiskFDA
Natus Medical Incorporated
EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only
Medical Devices·3,336 affected·Nov 28, 2023
High RiskFDA
Natus Medical Incorporated
External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only
Medical Devices·2,686 affected·Nov 28, 2023
High RiskFDA
Wells Pharma Of Houston Llc
ceFAZolin sodium in Sterile Water for injection, Injectable Solution, 1g/10mL (0.1 g per mL), Syringe, Rx only, Wells Pharma, NDC 73702-1...
Injectable Drugs·825 affected·Nov 22, 2023
High RiskFDA
Anazaohealth Corporation
B-Complex, Thiamine HCI / Riboflavin / Niacinamide / Dexpanthenol / Pyridoxine HCI injection, 74/2/75/2/2 MG/ML, 30ML Sterile Multiple-Do...
Injectable Drugs·5,707 affected·Nov 22, 2023
High RiskFDA
Medtronic Inc.
Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.
Medical Implants·1 affected·Nov 20, 2023
High RiskFDA
Covidien Lp
AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5 mm- -intended for fixation of prosthetic material to soft tissue in ...
Medical Implants·54 affected·Nov 16, 2023
CriticalFDA
Medline Industries, Lp - Northfield
MEDLINE TRAY TRACH BASIC SOLUTION, REF DYND40511
Medical Devices·385,028 affected·Nov 15, 2023
CriticalFDA
Medline Industries, Lp - Northfield
Medline Kits, trays, and packs labeled as follows: C-SECTION, REF DYNJ904653G
Medical Devices·483 affected·Nov 15, 2023
CriticalFDA
Medline Industries, Lp - Northfield
Centurion Kits, trays, and packs labeled as follows: a) IV SECUREMENT KIT, REF IVS1860B; b) NEONATAL PICC LINE INSERTION TRAY, REF C...
Medical Devices·11,812 affected·Nov 15, 2023
CriticalFDA
Medline Industries, Lp - Northfield
Medline Kits, trays, and packs labeled as follows: a) GYN LAPAROSCOPY, REF CDS984900M; b) GYN LAPAROSCOPY CDS, REF CDS983913S; c) ...
Medical Devices·533 affected·Nov 15, 2023
CriticalFDA
Medline Industries, Lp - Northfield
MEDLINE Kits, trays, and packs labeled as follows: a) ASC GENERAL MINOR CDS, REF CDS983673G; b) ASC GENERAL MINOR CDS, REF CDS983673...
Respiratory Devices·3,297 affected·Nov 15, 2023
CriticalFDA
Medline Industries, Lp - Northfield
Medline Kits, trays, and packs labeled as follows: a) C L PREP, REF DYNJ69664; b) DMEK PREP PACK, REF DYNJ81659A; c) PRE OP KIT 1,...
Medical Devices·1,270 affected·Nov 15, 2023
CriticalFDA
Medline Industries, Lp - Northfield
Medline Kits, trays, and packs labeled as follows: a) PORT REMOVAL PACK, REF DYNDA2936; b) PORT REMOVAL PACK, REF DYNDA2936H
Medical Devices·16 affected·Nov 15, 2023
CriticalFDA
Medline Industries, Lp - Northfield
MEDLINE Kits, trays, and packs labeled as follows: CATHETERIZATION KIT, REF DYNDA2939
Surgical Devices·18 affected·Nov 15, 2023
CriticalFDA
Medline Industries, Lp - Northfield
MEDLINE Kits, trays, and packs labeled as follows: a) DIALYSIS FISTULA KIT, REF DYNDC3106, b) ENDO KIT, REF DYKE1346D, c) ENDO KIT...
Medical Implants·0 affected·Nov 15, 2023
CriticalFDA
Medline Industries, Lp - Northfield
Medline Kits, trays, and packs labeled as follows: a) TRACH CARE KIT, REF DYND40589; b) TRACH CARE KIT, REF DYNDA3004; c) TRACHEOS...
Medical Devices·991,744 affected·Nov 15, 2023
CriticalFDA
Medline Industries, Lp - Northfield
Medline Kits, trays, and packs labeled as follows: a) CENTRAL LINE TRAY, REF CVI4705; b) DAILY DRIVELINE MGMT KIT w/PER, REF DT18700...
Medical Devices·86,699 affected·Nov 15, 2023
CriticalFDA
Medline Industries, Lp - Northfield
MEDLINE Kits, trays, and packs labeled as follows: a) ASC MINOR THYROID CDS, REF CDS983682F; b) BRONCHOSCOPY KIT, REF DYKE1718A; c...
Medical Devices·0 affected·Nov 15, 2023
CriticalFDA
Medline Industries, Lp - Northfield
Medline Kits, trays, and packs labeled as follows: TRAY,L&D INSTRUMENT, REF DYNDL1550
Medical Devices·228 affected·Nov 15, 2023
CriticalFDA
Medline Industries, Lp - Northfield
MEDLINE Kits, trays, and packs labeled as follows: a) ARTERIAL LINE PACK, REF DYNJ65208A; b) CANCER SERVICE PORT KIT, REF DT22710; ...
Medical Implants·0 affected·Nov 15, 2023
CriticalFDA
Medline Industries, Lp - Northfield
Centurion Kits, trays, and packs labeled as follows: MAINTENANCE FLUSH KIT/BLOOD DRAW, REF DT19335A
Medical Devices·220 affected·Nov 15, 2023
CriticalFDA
Medline Industries, Lp - Northfield
MEDLINE Kits, trays, and packs labeled as follows: a) ENDO KIT, REF DYKE1350D; b) PANENDOSCOPY-LF, REF DYNJ36728C; c) UMBILICAL...
Medical Devices·1,184 affected·Nov 15, 2023
CriticalFDA
Medline Industries, Lp - Northfield
Medline Kits, trays, and packs labeled as follows: a) BLOOD DRAW KIT, REF DYNDV2183A; b) LCPH LAB DRAW KIT, REF DYNDH1641A; c) LCP...
Medical Devices·0 affected·Nov 15, 2023
CriticalFDA
Medline Industries, Lp - Northfield
Medline Kits, trays, and packs labeled as follows: a) CATARACT PACK, REF VAL011CTASD; b) CATARACT PACK, REF DYNJ68875F; c) CATARAC...
Medical Devices·5,724 affected·Nov 15, 2023
CriticalFDA
Medline Industries, Lp - Northfield
Medline Kits, trays, and packs labeled as follows: a) 709E RECOVERY PACK A,B,C II SS, REF DYNJ55960G; b) ABDOMEN PACK, REF DYNJ53643...
Surgical Devices·26,171 affected·Nov 15, 2023
CriticalFDA
Medline Industries, Lp - Northfield
MEDLINE Kits, trays, and packs labeled as follows: a) C-SECTION, REF DYNJ904653G; b) DRESSING TRAY, REF M101426; c) ENDO KIT, REF ...
Medical Devices·5,969 affected·Nov 15, 2023
CriticalFDA
Medline Industries, Lp - Northfield
Medline Kits, trays, and packs labeled as follows: a) KIT,SUCTION CATH,10FR W/WATER, REF DYND41470; b) KIT,SUCTION CATH,12FR W/H20 1...
Surgical Devices·1,012,700 affected·Nov 15, 2023
CriticalFDA
Medline Industries, Lp - Northfield
Centurion Kits, trays, and packs labeled as follows: CIRCUMCISION TRAY, REF DYNDA2271
Medical Devices·1,260 affected·Nov 15, 2023
CriticalFDA
Medline Industries, Lp - Northfield
MEDLINE TRAY care and cleaning kits and trays for Tracheostomy and Stomas, labeled as: a) STOMA & TRACH CLEANING KIT, REF DYNDJ1129; ...
Medical Devices·2,683,387 affected·Nov 15, 2023
CriticalFDA
Medline Industries, Lp - Northfield
MEDLINE Kits, trays, and packs labeled as follows: SERUM TEAR KIT, REF DYNDA1545
Medical Devices·0 affected·Nov 15, 2023
CriticalFDA
Medline Industries, Lp - Northfield
Medline Kits, trays, and packs labeled as follows: CHP WOUND IRRIGATION KIT, REF DYK1017614W
Medical Devices·2,205 affected·Nov 15, 2023
CriticalFDA
Medline Industries, Lp - Northfield
Medline Kits, trays, and packs labeled as follows: a) NUR 105, REF EDUC05053B; b) NUR 213, REF EDUC05054B; c) NURSING SKILLS, REF ...
Medical Devices·844 affected·Nov 15, 2023
CriticalFDA
Medline Industries, Lp - Northfield
Centurion Kits, trays, and packs labeled as follows: EYE PREP KIT, REF ET1010
Medical Devices·60 affected·Nov 15, 2023
CriticalFDA
Kilitch Healthcare India Limited
Up&Up brand dry eye relief (Carboxymethylcellulose 0.5%) packaged in 0.5 FL OZ (15 mL) each bottles (Twin Pack), Distributed by: Target C...
Drugs·137,544 affected·Nov 13, 2023