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
Medline AMBULATORY MINI PACK, REF DYNJ82579; medical procedure convenience kit
Medical Devices·144 affected·Sep 4, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline brand medical procedure convenience kits, labeled as: 1) NEW LONDON TOTAL KNEE CDS, REF CDS982519W; 2) HAND/FOOT CDS, REF CD...
Medical Devices·2,371 affected·Sep 4, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline brand medical procedure convenience kits, labeled as: 1) EYE PACK, REF DYNJ19492L; 2) PHACO PACK, REF DYNJ22354L; 3) EYE PACK...
Medical Devices·27,906 affected·Sep 4, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline brand medical procedure convenience kit, labeled as: a) PAIN PROCEDURE PACK, REF DYNJ80370A; b) DR HEFZY BLOCK TRAY, REF DYNJRA1...
Medical Devices·320 affected·Sep 4, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline DIALYSIS PACK, REF DYNJ36932A; medical procedure convenience kit
Medical Devices·90 affected·Sep 4, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Centurion EP LAB INSTRUMENT KIT, REF MNS10480; medical procedure convenience kit
Medical Devices·90 affected·Sep 4, 2024
High RiskFDA
Howmedica Osteonics Corp.
Triathlon Universal TS Baseplate Size 2 - A single use sterile implantable device intended for cemented applications during primary and r...
Medical Implants·16 affected·Sep 4, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline CENTRAL CATHETER INSERTION TRA, REF CVI680C; medical procedure convenience kit
Surgical Devices·1,180 affected·Sep 4, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline TUBAL LIGATION PACK, REF DYNJ66230B; medical procedure convenience kit
Medical Devices·22 affected·Sep 4, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline brand medical procedure convenience kits, labeled as: 1) THORACENTESIS TRAY, REF 00-400616J; 2) HH PACK SONICATION SPEC CONTAI, ...
Cardiac Devices·22,327 affected·Sep 4, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Centurion PEDIATRIC/ADULT TRACHEOSTOMY T, REF TC7895; medical procedure convenience kit
Medical Devices·30 affected·Sep 4, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline brand, medical procedure convenience kits, labeled as: a) RADIOLOGY LP TRAY, REF DYNDH1609; b) CARDIAC CATH PACK-LF, REF DYN...
Cardiac Devices·1,460 affected·Sep 4, 2024
RecallFDA
Trackx Technology Inc
Product Name: Insight Base Flex - 8, Ref 608-3TX; The device consists of a sterile Snap that includes reflective features that facilitate...
Surgical Devices·82 affected·Sep 3, 2024
High RiskFDA
Merit Medical Systems, Inc.
Melrose Wakefield Hospital REF K05T-2159 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is...
Surgical Devices·432 affected·Aug 30, 2024
High RiskFDA
Merit Medical Systems, Inc.
Monarch Inflation Device 30 atm/bar MAP152 AssessPLUS Large Bore Hemostasis Valve Metal Insertion Tool Torque Device REF IN2530 Inject...
Surgical Devices·51,900 affected·Aug 30, 2024
High RiskFDA
Merit Medical Systems, Inc.
Monarch Inflation Device 30 atm/bar REF IN2130 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syr...
Surgical Devices·110,650 affected·Aug 30, 2024
High RiskFDA
Tornier, Inc
stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A; anatomic total arthroplasty of the shoulder
Medical Devices·5 affected·Aug 29, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline Sterile Laparoscopy Pack, DYNJ68187A (REF), containing the component ConMed/Unimax Detachable Endo Pocket
Medical Devices·72 affected·Aug 28, 2024
High RiskFDA
Prorx Llc
Tirzepatide 2 mL (10 mg/mL) and 20 mg/mL, 2mL Multidose SC Injection vials, Compounded Rx Product, ProRx 267-565-7008, NDC 84139-210-01
Injectable Drugs·37 affected·Aug 22, 2024
High RiskFDA
Prorx Llc
Semaglutide, 2 mL (2.5mg/mL), Compounded RX Product, Multidose SC inj, glass vial, ProRx, 267-565-7008, NDC 84139-225-01
Drugs·2,490 affected·Aug 22, 2024
High RiskFDA
Prorx Llc
Semaglutide / Cyanocobalamin Injection: 2.5/0.5 mg/mL, 2 mL Multiple Dose Vial, Compounded Rx Product, ProRX 267-565-7008, NDC 84139-225-02
Injectable Drugs·500 affected·Aug 22, 2024
High RiskFDA
Prorx Llc
SEMAGLUTIDE 5mg/2mL (2.5mg/mL), Rx Only 2 mL Multiple Dose Vial, Rx Only, Compounded Drug, Mfd by: ProRX Exton, PA19341, NDC 84139-225-01
Drugs·8,396 affected·Aug 22, 2024
High RiskFDA
Prorx Llc
TIRZEPATIDE 60 mg/3mL (20/mg/mL), Rx Only, 3mL Multiple Dose Vial, Mfd by: ProRx Exton, PA, 19341, NDC 84139-210-02
Drugs·1,732 affected·Aug 22, 2024
High RiskFDA
Prorx Llc
TIRZEPATIDE 20 mg/2mL (10/mg/mL), Rx Only, 2mL Multiple Dose Vial, Mfd by: ProRx Exton, PA, 19341, NDC 84139-210-01
Drugs·1,489 affected·Aug 22, 2024
High RiskFDA
Prorx Llc
SEMAGLUTIDE 10mg/4mL (2.5mg/mL), 4 mL Multiple Dose Vial, Rx Only, Compounded Drug, Mfd by: ProRX Exton, PA19341, NDC 84139-225-04
Drugs·1,960 affected·Aug 22, 2024
CriticalFDA
Baxter Healthcare Corporation
Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a pharmaceutical compounding device
Medical Devices·2,140,046 affected·Aug 20, 2024
CriticalFDA
Baxter Healthcare Corporation
Baxter EXACTAMIX Inlet, Vented, High Volume Inlet, REF H938174, for use in a pharmaceutical compounding device
Medical Devices·1,548,782 affected·Aug 20, 2024
CriticalFDA
Baxter Healthcare Corporation
Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175, for use in a pharmaceutical compounding device
Medical Devices·5,828,540 affected·Aug 20, 2024
High RiskFDA
Merit Medical Systems, Inc.
basixTOUCH Inflation Device, REF: IN8130/JPC, IN8152/C, IN8302/C, IN8352/C, IN8802/C, IN8130/C, IN8130/C
Medical Devices·16,439 affected·Aug 19, 2024
High RiskFDA
Merit Medical Systems, Inc.
Custom Inflation Kit, REF: K05-00052M, K05-00053H, K05-00109G, K05-00137K, K05-00296L, K05-00399D, K05-00404C, K05-00410G, K05-00438G, K0...
Medical Devices·7,099 affected·Aug 19, 2024
High RiskFDA
Merit Medical Systems, Inc.
basixSKY Inflation Device, REF: SKY1802
Medical Devices·70 affected·Aug 19, 2024
High RiskFDA
Merit Medical Systems, Inc.
MONARCH Inflation Device, REF: IN2430/B, IN2530/B, IN2130/B
Medical Devices·12,910 affected·Aug 19, 2024
High RiskFDA
Merit Medical Systems, Inc.
DiamondTOUCH Digital Inflation Device, REF: IN9135/A, IN9152/A
Medical Devices·290 affected·Aug 19, 2024
High RiskFDA
Merit Medical Systems, Inc.
Blue Diamond Digital Inflation Device, REF: IN7152/C, IN7352/C, IN7403/C, IN7802/C, IN7852/C, IN7130/C
Medical Devices·14,120 affected·Aug 19, 2024
High RiskFDA
Fagron Compounding Services
Lidocaine HCl Injection, 2% (20mg per mL) (100 mg per 5 mL) per syringe, Rx only, Fagron Sterile Services, 8710 E. 34th St, N. Wichita, K...
Injectable Drugs·0 affected·Aug 15, 2024
High RiskFDA
Smith & Nephew Inc.
ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixation of prosthetic material to soft tissues. Product Number: 7...
Medical Implants·2,961 affected·Aug 12, 2024
High RiskFDA
American Contract Systems, Inc.
Pacemaker, COPM11B; Medical convenience kit
Cardiac Devices·3 affected·Aug 7, 2024
High RiskFDA
American Contract Systems, Inc.
Hand Pack, AKHD97C; Medical convenience kit
Medical Devices·2 affected·Aug 7, 2024
High RiskFDA
American Contract Systems, Inc.
Vaginal Delivery, ASDV25B; Medical convenience kit
Medical Devices·1 affected·Aug 7, 2024
High RiskFDA
American Contract Systems, Inc.
IR Procedure Pack, CEAT19W; Medical convenience kit
Medical Devices·1 affected·Aug 7, 2024
High RiskFDA
American Contract Systems, Inc.
Nasal Sinus Pack, MTSN26B; Medical convenience kit
Medical Devices·57 affected·Aug 7, 2024
High RiskFDA
American Contract Systems, Inc.
PACEMAKER PACK, SLCV01J; Medical convenience kit
Cardiac Devices·20 affected·Aug 7, 2024
High RiskFDA
American Contract Systems, Inc.
Neuro Vascular, ANKV91A; Medical convenience kit
Medical Devices·1 affected·Aug 7, 2024
High RiskFDA
American Contract Systems, Inc.
Bilateral Tubal Ligation Pack, FHBT3T; Medical convenience kit
Medical Devices·18 affected·Aug 7, 2024
High RiskFDA
American Contract Systems, Inc.
Paracentesis Thoracente, SLPT76H; Medical convenience kit
Medical Devices·504 affected·Aug 7, 2024
High RiskFDA
American Contract Systems, Inc.
Cath Lab Pack, CECL02P; Medical convenience kit
Medical Devices·1 affected·Aug 7, 2024
High RiskFDA
American Contract Systems, Inc.
Endovascular AAA Pack, ESED52B; Medical convenience kit
Medical Devices·93 affected·Aug 7, 2024
High RiskFDA
American Contract Systems, Inc.
Shoulder, SESH18I; Medical convenience kit
Medical Devices·60 affected·Aug 7, 2024