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
Medline Industries, Lp - Northfield
URINE COLLECTION VHC, SKU DYLAB1016; Component No. 503581
Medical Devices·626,305 affected·Oct 23, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Clean Catch Kit, SKU DYKM1833A; Component No. 503581
Medical Devices·626,305 affected·Oct 23, 2024
High RiskFDA
Medline Industries, Lp - Northfield
UA KIT, SKU DYKM1690A; Component No. 503581
Medical Devices·626,305 affected·Oct 23, 2024
High RiskFDA
Medline Industries, Lp - Northfield
URINE COLLECTION KIT, SKU DYKM1848A DYKM2005 DYKM2151 DYLAB1004 DYLAB1004A DYLAB1006 DYLAB1012 ; Component No. 503581
Medical Devices·626,305 affected·Oct 23, 2024
High RiskFDA
Carwild Corporation
Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid Management Model Number: Q604237
Surgical Devices·300 affected·Oct 22, 2024
High RiskFDA
Carwild Corporation
Ivalon Eye Wick 20cm- Intended to be used for the removal and collection of fluids from the Opthalmic surgical site. Model Number: Q6...
Surgical Devices·120 affected·Oct 22, 2024
High RiskFDA
Carwild Corporation
Ivalon Anatomical Nasal Packing with Airway Tube and String, 8.0 cm x 1.5cmx 3.0 cm- Intended To Be Used During Ophthalmic Surgical Proce...
Surgical Devices·140 affected·Oct 22, 2024
High RiskFDA
Human Med Ag
human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use.
Medical Devices·775 affected·Oct 18, 2024
High RiskFDA
Maquet Cardiovascular, Llc
Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000Z
Medical Devices·33,823 affected·Oct 16, 2024
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE procedure kits labeled as follows: 1) 20G EPI CATH SINGLE STERILE, REF EPICATH19 2) 20G EPI CATH SINGLE STERILE, REF EPICATH20
Medical Devices·5,975 affected·Oct 16, 2024
High RiskFDA
Maquet Cardiovascular, Llc
Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000Z
Medical Devices·10,778 affected·Oct 16, 2024
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE procedure kits labeled as follows: 1) COMBINED SPINAL AND EPIDURAL, REF DYNJRA1268B; 2) COMBINED SPINAL AND EPIDURAL, REF DY...
Surgical Devices·0 affected·Oct 16, 2024
High RiskFDA
Corneat Vision, Ltd.
CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 6.5 mm x 100 um, SterileEO, RX only
Surgical Devices·0 affected·Oct 16, 2024
High RiskFDA
Smith & Nephew, Inc.
Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar ...
Medical Devices·21 affected·Oct 15, 2024
High RiskFDA
Medline Industries, Lp - Northfield
(1) Medline Pacer Implant Pack, REF DYNJ59194A, 4 kits/case, sterile; and (2) Medline Thoracotomy Morristown, REF DYNJ904220F, 1 kit/cas...
Medical Implants·360 affected·Oct 15, 2024
High RiskFDA
Medline Industries, Lp - Northfield
(1) Medline Open Heart CDS, REF CDS840132O, packaged 1 kit/case, non-sterile; and (2) Medline Dr. Davies CV, REF DYNJ903016G, packaged 1...
Cardiac Devices·408 affected·Oct 15, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline Shoulder Repair Pack-LF, REF DYNJ82607, 2 kits/case, sterile.
Medical Devices·48 affected·Oct 15, 2024
High RiskFDA
Advanced Medical Solutions Ltd.
MEDLINE MAXORB EXTRA ALGINATE WOUND DRESSING 4X4 SQUARE REF MSC7044EP MEDLINE MOXORB EXTRA ALBINATE WOUND DRESSING 4X8 RECTANLE REF MSC7...
Medical Devices·1,800 affected·Oct 1, 2024
High RiskFDA
Advanced Medical Solutions Ltd.
McKesson Calcium Alginate Dressing MFR# 3562 Wound dressing indicated for moderate to heavily exuding chronic and acute wounds, and to...
Medical Devices·8,000 affected·Oct 1, 2024
High RiskFDA
King Systems Corp. Dba Ambu, Inc.
AMBU / KING LTSD, SIZE 0,1 W/SUCTION PORT, STERILE- Inserted into a patient s pharynx through the mouth to provide patent airway. Model...
Medical Devices·0 affected·Sep 26, 2024
High RiskFDA
King Systems Corp. Dba Ambu, Inc.
KING LTSD,SIZE 1,W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Num...
Medical Devices·21,939 affected·Sep 26, 2024
High RiskFDA
King Systems Corp. Dba Ambu, Inc.
KING LTSD,SIZE 2.5, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/...
Medical Devices·36,727 affected·Sep 26, 2024
High RiskFDA
King Systems Corp. Dba Ambu, Inc.
KING LTSD,SIZE 1, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Cat...
Medical Devices·21,591 affected·Sep 26, 2024
High RiskFDA
Fresenius Kabi Compounding, Llc
NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton,...
Injectable Drugs·733 affected·Sep 25, 2024
High RiskFDA
Fresenius Kabi Compounding, Llc
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC...
Injectable Drugs·2,756 affected·Sep 25, 2024
High RiskFDA
Fresenius Kabi Compounding, Llc
EPINEPHrine 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-...
Injectable Drugs·753 affected·Sep 25, 2024
High RiskFDA
Fresenius Kabi Compounding, Llc
Oxytocin 0.9% Sodium Chloride Injection USP, 30 units per 500 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506...
Injectable Drugs·4,436 affected·Sep 25, 2024
High RiskFDA
Fresenius Kabi Compounding, Llc
NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 4 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton,...
Injectable Drugs·2,151 affected·Sep 25, 2024
High RiskFDA
Fresenius Kabi Compounding, Llc
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC...
Injectable Drugs·1,631 affected·Sep 25, 2024
High RiskFDA
Fresenius Kabi Compounding, Llc
Thiamine HCl 0.9% Sodium Chloride Injection USP, 500 mg per 100 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71...
Injectable Drugs·1,008 affected·Sep 25, 2024
High RiskFDA
Fresenius Kabi Compounding, Llc
Vancomycin HCl 750 mg per 250 mL 0.9% Sodium Chloride Injection USP, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71...
Injectable Drugs·1,082 affected·Sep 25, 2024
High RiskFDA
Fresenius Kabi Compounding, Llc
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC...
Injectable Drugs·1,313 affected·Sep 25, 2024
High RiskFDA
Fresenius Kabi Compounding, Llc
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC...
Injectable Drugs·1,378 affected·Sep 25, 2024
High RiskFDA
Orthofix Srl
REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile
Medical Devices·2 affected·Sep 24, 2024
High RiskFDA
Advanced Accelerator Applications Usa, Inc.
Pluvicto, 1000 MBq/mL (27 mCi/mL), lutetium, LU 177, vipivotide tetraxetan injection, Single-dose vial, Sterile, Manufacturer Advanced Ac...
Injectable Drugs·99 affected·Sep 23, 2024
High RiskFDA
Pro-dex Inc
KLS Martin Battery Pack, REF: KLS BP2 001, and KLS BP2 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver 2.0 surgi...
Surgical Devices·2,000 affected·Sep 23, 2024
High RiskFDA
Microsurgical Technology Inc
Brand Name: MST Duet Reusable Handle for Single Use Heads Product Name: Reusable Handle for Single Use Heads (Forceps and Scissors) Mod...
Surgical Devices·24 affected·Sep 17, 2024
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% (sterile), 15 mL bottle, Rx only, MFG: Bausch & Lomb, NDC 24208-730-06
Ophthalmic Drugs·27 affected·Sep 11, 2024
High RiskFDA
Empower Pharmacy
Pyridoxine HCL (B6) Injection Solution, 100mg/mL, 30 mL Sterile Multiple-Dose Vial, For IM or IV use only, RX Only, Compounded by: Empowe...
Injectable Drugs·450 affected·Sep 5, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline brand medical procedure convenience kits, labeled as: a) LITHOTOMY PACK, REF DYNJ24362C; b) MAJOR GYNE LAPAROSCOPY SHSC, REF...
Medical Devices·197 affected·Sep 4, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline brand medical procedure convenience kits, labeled as: a) PLASTIC PACK, REF DYNJ42735A; b) DR SELEM PACK, REF DYNJ43457; c)...
Medical Devices·1,048 affected·Sep 4, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline brand medical procedure convenience kits, labeled as: a) TRAY ADD A CATH FOL UM MF 10ML, REF DYND150200S; b) TRAY FOL LATX U...
Medical Devices·8,830 affected·Sep 4, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline CHEST TUBE INSERTION TRAY ADUL, REF CHT1165; medical procedure convenience kit
Medical Devices·15 affected·Sep 4, 2024
High RiskFDA
Bard Peripheral Vascular Inc
The EVSRF catheter is a sterile, single-use disposable medical device for endovenous radiofrequency ablation, a procedure in which a refl...
Surgical Devices·222,373 affected·Sep 4, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline DENTAL PACK, REF DYNJ64086B; medical procedure convenience kit
Medical Devices·165 affected·Sep 4, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline brand, medical procedure convenience kits, labeled as: a) CUH OPEN HEART A B C - CDS, REF CDS983202I; a) PICC INSERTION KIT,...
Cardiac Devices·2,631 affected·Sep 4, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Centurion OB TRAY, REF MNS13965A; medical procedure convenience kit
Medical Devices·30 affected·Sep 4, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline EYE PACK, REF LYN036EPESB; medical procedure convenience kit
Medical Devices·160 affected·Sep 4, 2024