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
Synovo Production
Femoral Resurfacing Cup - (xx)MM, Ti-6AI-4V ELI, TiN CERAMIC W/ PLASMA SPRAY, STERILEEO, Reference Numbers: 01-03-0042 01-03-0044 01-03-0...
Medical Devices·496 affected·May 30, 2023
High RiskFDA
Deroyal Industries Inc
Custom medical procedure packs labeled as: a) CATH ANGIOGRAPHY DRAPE PACK, REF 89-7102; b) CHOLANGIOGRAPHY KIT, REF 89-7322; c) ...
Medical Devices·306 affected·May 30, 2023
High RiskFDA
Deroyal Industries Inc
Custom medical procedure packs labeled as: a) OPEN HEART TRACECART, REF '53-1941; b) CARDIAC CATH PACK, REF '89-10045; c) SHOUL...
Cardiac Devices·4,225 affected·May 30, 2023
High RiskFDA
Deroyal Industries Inc
Custom medical procedure packs labeled as: a) STURDI STRAINER TRAY STANDARD, REF '89-5014
Medical Devices·40 affected·May 30, 2023
High RiskFDA
Deroyal Industries Inc
Custom medical procedure packs labeled as: a) PELVIC EXAM TRAY, REF 89-6219
Medical Devices·3 affected·May 30, 2023
High RiskFDA
Olympus Corporation Of The Americas
Tracheal Intubation Fiberscope OLYMPUS LF-P- To be used with an Olympus Light Source, documentation equipment, display monitor and other ...
Medical Devices·686 affected·May 26, 2023
High RiskFDA
Olympus Corporation Of The Americas
Olympus Endoscope Reprocessor OER-Mini-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and ...
Medical Devices·241 affected·May 26, 2023
High RiskFDA
Olympus Corporation Of The Americas
Olympus Endoscope Reprocessor OER-Elite-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and...
Medical Devices·1,063 affected·May 26, 2023
High RiskFDA
Golden State Medical Supply Inc.
Travoprost Ophthalmic Solution, USP (Ionic Buffered Solution), 0.004%, Rx only, Manufactured by Apotex Inc., Manufactured by: GSMS Incor...
Ophthalmic Drugs·1,920 affected·May 25, 2023
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx only, Fresenius Medical Care North America, Waltham, MA 02451, ...
Injectable Drugs·53,424 affected·May 23, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Centurion Sterile CirClamp with 1.45cm Bell Reprocessed, Reorder CR3145K, 1 per package, 12 per case.
Medical Devices·106 affected·May 23, 2023
High RiskFDA
Sagent Pharmaceuticals Inc
Nafcillin for Injection, USP, 10 gram per Pharmacy Bulk Package, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 2...
Injectable Drugs·370,200 affected·May 19, 2023
High RiskFDA
Sagent Pharmaceuticals Inc
Nafcillin for Injection, USP, 2 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-140-10
Injectable Drugs·2,249,980 affected·May 19, 2023
High RiskFDA
Sagent Pharmaceuticals Inc
Nafcillin for Injection, USP, 1 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-139-10
Injectable Drugs·2,249,980 affected·May 19, 2023
High RiskFDA
Qiagen Gmbh
QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients s...
Respiratory Devices·386 affected·May 19, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CVC PACK, Model Number DYNJ46967F; b) END...
Surgical Devices·4,644 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FETAL SURGERY CDS-LF, Model Number CDS840214Q; ...
Surgical Devices·770,147 affected·May 18, 2023
High RiskFDA
Maquet Medical Systems Usa
QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 10000-USA ...
Respiratory Devices·0 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a. NORTON CHILDRENS CATH LAB-LF, Model Number 00-...
Cardiac Devices·172,722 affected·May 18, 2023
High RiskFDA
Maquet Medical Systems Usa
QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model Item no. BEQ-HMO 50000-USA ...
Respiratory Devices·1,784 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATHETERLESS INSERTION KIT, Model Number CVI45...
Surgical Devices·620 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) TOTAL JOINT, Model Number CDS985555S; b) TOTA...
Medical Devices·4,500 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY PACK, Model Number DYNJ55252C; b) ...
Cardiac Devices·3,740,814 affected·May 18, 2023
High RiskFDA
Maquet Medical Systems Usa
QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 30000-USA 701070384 HM...
Respiratory Devices·0 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: BREAST BIOPSY TRAY, Model Number SPEC0130C
Medical Devices·1,240 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY DRP PK PEDI CATH, Model Number 00-4...
Cardiac Devices·55,014 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CVC INFANT INSERTION PACK, Model Number CVI4770...
Medical Devices·572 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VANTEX CVC BNDL, 3L 7F 16CM W MICROCLAVE, Model ...
Surgical Devices·10,080 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: KIT,SUCTION CATH,14FR W/WATER, Model Number DYND41472
Medical Devices·24,192 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: ARTHROSCOPY PACK, Model Number DYNJ44322G
Medical Devices·180 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: PROBE COVER PACK, Model Number DYNDA1219
Medical Devices·51,200 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) RADIAL ARTERIAL LINE KIT, Model Number ART1070A...
Surgical Devices·2,590 affected·May 18, 2023
High RiskFDA
Maquet Medical Systems Usa
BEQ-HMO 50000-USA/ QUADROX-i Small, Oxygenator used during cardiopulmonary bypass Item no. 701067905
Respiratory Devices·1,784 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VAD/PICC IV KIT, Model Number DYNDV2200; b)...
Medical Devices·8,974 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: PACK ENDO AAA HYBRID CHRG, Model Number DYNJ60126B
Medical Devices·25 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ARTERIAL LINE START KIT , Model Number ART920; ...
Medical Devices·70,648 affected·May 18, 2023
High RiskFDA
Maquet Medical Systems Usa
QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 10000-USA 701070412 HMO ...
Respiratory Devices·0 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: PEDIATRIC EP PACK, Model Number DYNJ45158A
Medical Devices·36 affected·May 18, 2023
High RiskFDA
Maquet Medical Systems Usa
QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 70000-USA ...
Respiratory Devices·0 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BLOCK PACK, Model Number DYNJ81722; b) PAIN B...
Surgical Devices·28,568 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BREAST PACK, Model Number DYNDH1306; b) BRS...
Medical Devices·4,398 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ULTRASOUND PACK, Model Number DYNDH1112; b) ...
Medical Devices·575 affected·May 18, 2023
High RiskFDA
Maquet Medical Systems Usa
QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass Model Item No. HMOD 70000-USA 701...
Respiratory Devices·24,250 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VNUS TRAY, Model Number DYNJ44410G; b) INTRAU...
Medical Devices·2,420 affected·May 18, 2023
High RiskFDA
Maquet Medical Systems Usa
QUADROX-iD Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. BEQ-HMOD30000-U...
Respiratory Devices·5,022 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) MHC VASCULAR HYBRID PK-LF, Model Number DYNJ534...
Cardiac Devices·3,740,814 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: STERILE SET FOR IMPLANT-LF, Model Number OST011F
Medical Implants·1,130 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CRANIOTOMY CDS-1, Model Number CDS982889I; ...
Medical Implants·19,940 affected·May 18, 2023