Media, Coupling, Ultrasound
Radiology · 21 CFR 892.1570
Recent MDR events
70 adverse event reports on file
- POLYSONIC® ULTRASOUND LOTIONJun 9, 2026InjuryParker Laboratories, Inc2212018-2026-00001
- ECOVUE ULTRASOUND GELDec 23, 2025InjuryHr Pharmaceuticals, Inc. / D/b/a Hr HealthcareMW5181141
- ECOVUE ULTRASOUND GELDec 23, 2025InjuryHr Pharmaceuticals, Inc. / D/b/a Hr HealthcareMW5181142
- ECOVUE ULTRASOUND GELDec 23, 2025InjuryHr Pharmaceuticals, Inc. / D/b/a Hr HealthcareMW5181143
- ECOVUE ULTRASOUND GELDec 23, 2025InjuryHr Pharmaceuticals, Inc. / D/b/a Hr HealthcareMW5181144
- ECOVUE ULTRASOUND GELDec 23, 2025InjuryHr Pharmaceuticals, Inc. / D/b/a Hr HealthcareMW5181145
- ECOVUE ULTRASOUND GELDec 23, 2025InjuryHr Pharmaceuticals, Inc. / D/b/a Hr HealthcareMW5181146
- ECOVUE ULTRASOUND GELDec 23, 2025InjuryHr Pharmaceuticals, Inc. / D/b/a Hr HealthcareMW5181147
- ECOVUE ULTRASOUND GELDec 23, 2025InjuryHr Pharmaceuticals, Inc. / D/b/a Hr HealthcareMW5181148
- ECOVUE ULTRASOUND GELDec 23, 2025InjuryHr Pharmaceuticals, Inc. / D/b/a Hr HealthcareMW5181149
Event type breakdown
Recalls
6 recall events for this product code
- Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. ve Tic. A.S.Open, ClassifiedJan 20, 2024
REF: 126590, MEDLINE, STERILE ULTRASOUND GEL, 0.70 FL oz. (20 mL), QTY: 50, STERILER, CE 2292
Sterility of Ultrasound gel can not be guaranteed.
Z-0777-2024 · View FDA record ↗ - Advance Medical Designs, Inc.Open, ClassifiedSep 9, 2023
ASG-001; Ultrasound gel
Ultrasound gel mislabeled with inappropriate use.
Z-2532-2023 · View FDA record ↗ - Advance Medical Designs, Inc.Open, ClassifiedSep 9, 2023
50-GEL20; Ultrasound gel
Ultrasound gel mislabeled with inappropriate use.
Z-2533-2023 · View FDA record ↗ - Pharmaceutical Innovations, Inc.TerminatedMay 24, 2012
Other-Sonic Generic Ultrasound Transmission Gel 250 mL
Other-Sonic GENERIC ULTRASOUND TRANSMISSION GEL is being recalled due to possible microbial contamination. An FDA Safety Communication was issued for this product on April 18, 2012.
Z-1652-2012 · View FDA record ↗ - Pharmaceutical Innovations, Inc.TerminatedMay 24, 2012
Other-Sonic Generic Ultrasound Transmission Gel 5 Liters Hypoallergenic
Other-Sonic GENERIC ULTRASOUND TRANSMISSION GEL is being recalled due to possible microbial contamination. An FDA Safety Communication was issued for this product on April 18, 2012.
Z-1653-2012 · View FDA record ↗ - Pharmaceutical Innovations, Inc.TerminatedUnknown
Ultra/Phonic Focus BP Conforming Gel Pads, UDI 00300361301021 (Primary); 10300361301028 (Package) - Product Usage: A gel pad for use on woman s areola during an
The firm registered the product as a Class I device, but has since been informed by FDA that the device is not Class I and requires a 510(k) submission.
Z-2830-2020 · View FDA record ↗
Registered firms
33 firms currently registered for this product code
Sheathing Technologies, Inc.
MORGAN HILL, CA, US
Medical Action Industries, Inc. 306
ARDEN, NC, US
Changzhou Atomic Hi-tech Radiation Co., Ltd.
CHANGZHOU Jiangsu, CN
Parker Laboratories, Inc.
FAIRFIELD, NJ, US
Convertors De Mexico S. De R.l. De C.v
CD.JUAREZ Chihuahua, MX
Manamed Llc
Denton, TX, US
Dukal Llc
Ronkonkoma, NY, US
Pharmazeutische Fabrik Montavit Ges.m.b.h.
Absam Tirol, AT
Hr Pharmaceuticals, Inc D/b/a Hr Healthcare
York, PA, US
Ming Fai Industrial (shenzhen) Co. Ltd.
SHENZHEN Guangdong, CN
Pharmasept Ltd. Medical Products
Caesarea Central, IL
Safersonic Medizinprodukte Handelsges.m.b.h
Persenbeug Niederosterreich, AT
Medline Industries, Lp - Northfield
Northfield, IL, US
Foshan Pingchuang Medical Technology Co., Ltd
Foshan City Guangdong, CN
Cardinal Health 200, Llc
Waukegan, IL, US
Jkh Health Co., Ltd.
Dongguan Guangdong, CN
Advance Medical Designs, Inc.
MARIETTA, GA, US
Sterigenics U.s., Llc
Charlotte, NC, US
Anhui Deepblue Medical Technology Co., Ltd.
Hefei Anhui, CN
Edgecare Inc.
Yeongdeungpo-gu Seoul, KR
Jianerkang Medical Co., Ltd.
Changzhou City Jiangsu, CN
Compass Health Brands (corporate Office)
Middleburg Heights, OH, US
510(k) clearances
34 clearances for this product code
- Foshan Pingchuang Medical Technology Co., Ltd.Jun 17, 2026
K253255 · Non-Sterile Ultrasound Gel Sterile Ultrasound Gel
- Edgecare, Inc.Apr 24, 2026
K252337 · EdgeFlow Gel Pad
- Anhui Deepblue Medical Technology Co., Ltd.Sep 19, 2024
K242167 · Sterile and Non-Sterile Ultrasonic Coupling Agent
- Hony Medical Co., Ltd.Jul 24, 2024
K241789 · Non-Sterile Ultrasound Transmission Gels
- Jianerkang Medical Co., Ltd.Dec 15, 2023
K232957 · Sterile and Non-Sterile Ultrasound Gels
- Hony Medical Co., Ltd.Aug 30, 2022
K221999 · Ultrasound Transmission Gels
- Ultrast, Inc.Dec 22, 2021
K211691 · Ultrast Gel
- Safersonic Us, Inc.Oct 4, 2019
K190591 · Safergel Sterile Ultrasound Gel