510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Device recalls

Recall records from FDA, newest initiation date first.

Every device recall MDM has ingested. The recall record supplies the product, the reason and the product code; the matching enforcement report supplies the Class I, II or III classification. Where the two have not been joined, the class is left blank rather than assumed.

Data as of , the FDA export date. FDA medical device recall database

59,460 records, page 96 of 1190
FDA device recalls, page 96 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1218-2025Class IIA.L.P.S. mvX- ANATOMIC LAT FIB PLATE 12H RT- Anatomic Lateral Fibula Plate, 12-Hole...Tyber MedicalHRS
Z-1217-2025Class IIA.L.P.S. mvX-P: ANATOMIC LAT FIB PLATE 12H LT- Anatomic Lateral Fibula Plate, 12-Hole...Tyber MedicalHRS
Z-1216-2025Class IIA.L.P.S. mvX- ANATOMIC LAT FIB PLATE 10H RT- Anatomic Lateral Fibula Plate, 10-Hole...Tyber MedicalHRS
Z-1215-2025Class IIA.L.P.S. mvX- Product Name: ANATOMIC LAT FIB PLATE 10H LT Anatomic Lateral Fibula Plate...Tyber MedicalHRS
Z-1214-2025Class IIA.L.P.S. mvX- ANATOMIC LAT FIB PLATE 8H RT: Anatomic Lateral Fibula Plate, 8-hole...Tyber MedicalHRS
Z-1213-2025Class IIA.L.P.S. mvX- ANATOMIC LAT FIB PLATE 8H LT: Anatomic Lateral Fibula Plate, 8-hole...Tyber MedicalHRS
Z-1212-2025Class IIA.L.P.S. mvX- ANATOMIC LAT FIB PLATE 6H RT: Anatomic Lateral Fibula Plate, 6-hole...Tyber MedicalHRS
Z-1211-2025Class IIA.L.P.S. mvX -ANATOMIC LAT FIB PLATE 6H LT- Anatomic Lateral Fibula Plate, 6-hole...Tyber MedicalHRS
Z-1210-2025Class IIA.L.P.S. mvX -ANATOMIC LAT FIB PLATE 4H RT: Anatomic Lateral Fibula Plate, 4-hole...Tyber MedicalHRS
Z-1209-2025Class IIA.L.P.S. mvX - ANATOMIC LAT FIB PLATE 4H LT: Anatomic Lateral Fibula Plate, 4-hole...Tyber MedicalHRS
Z-1102-2025Class IILIFEPAK 35 ECG cable REF 11111-000041Physio Control, Inc.DSA
Z-1184-2025Class IILIFEPAK 15 V4/Masimo Rainbow Sensors: Masimo RD rainbow Adt 8 SpCO, SpO2, and SpMet...Physio Control, Inc.MKJ
Z-1164-2025Class IIMicrobiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated...Microbiologics, Inc.OHQ
Z-1163-2025Class IIMicrobiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated...Microbiologics, Inc.OHQ
Z-2463-2025Class IIBrand Name: HOMEDICS Product Name: Air Compression Leg Massager Model/Catalog Number...Zhejiang Luyao Electronics Technology Co., Ltd.IRP
Z-1176-2025Class II3M V.A.C. VIA Negative Pressure Wound Therapy System REF: VIAKIT077D01/US - V.A.C. VIA 7...KCI USA, Inc.OMP
Z-1175-2025Class II3M Prevena Plus 125 Therapy Unit and System Kits REF: PRE3021US Prevena Plus Duo Peel and...KCI USA, Inc.QFC
Z-1327-2025Class IIBrand Name: Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors Product...Spectrum Medical IncKFM
Z-1235-2025Class IIPlato 17 Microcatheter REF PL17-160-090 To assist in delivery of therapeutic devices and...Scientia VascularQJP
Z-1195-2025Class IIBrand Name: RayStation- Intended as a Radiation Therapy Treatment Planning...RaySearch Laboratories AB (publ)MUJ
Z-1194-2025Class IIBrand Name: RayStation- Intended as a Radiation Therapy Treatment Planning...RaySearch Laboratories AB (publ)MUJ
Z-1193-2025Class IIBrand Name: RayStation- Intended as a Radiation Therapy Treatment Planning...RaySearch Laboratories AB (publ)MUJ
Z-1192-2025Class IIBrand Name: RayStation- Intended as a Radiation Therapy Treatment Planning...RaySearch Laboratories AB (publ)MUJ
Z-1191-2025Class IIBrand Name: RayStation- Intended as a Radiation Therapy Treatment Planning...RaySearch Laboratories AB (publ)MUJ
Z-1190-2025Class IIBrand Name: RayStation- Intended as a Radiation Therapy Treatment Planning...RaySearch Laboratories AB (publ)MUJ
Z-1189-2025Class IIBrand Name: RayStation- Intended as a Radiation Therapy Treatment Planning...RaySearch Laboratories AB (publ)MUJ
Z-1188-2025Class IIBrand Name: RayStation- Intended as a Radiation Therapy Treatment Planning...RaySearch Laboratories AB (publ)MUJ
Z-1187-2025Class IIBrand Name: RayStation -Intended as a Radiation Therapy Treatment Planning...RaySearch Laboratories AB (publ)MUJ
Z-1186-2025Class IIBrand Name: RayStation -Intended as a Radiation Therapy Treatment Planning...RaySearch Laboratories AB (publ)MUJ
Z-1185-2025Class IIBrand Name: RayStation Intended as a Radiation Therapy Treatment Planning...RaySearch Laboratories AB (publ)MUJ
Z-1248-2025Class IIASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.Terragene LLCFRC
Z-1162-2025Class IIMOSAIQ Oncology Information SystemElekta LimitedIYE
Z-1110-2025Class IIIntelliVue Patient Monitor MX550. Model Number: 866066Philips North America LLCMHX
Z-1109-2025Class IIIntelliVue Patient Monitor MX500. Model Number: 866064Philips North America LLCMHX
Z-1108-2025Class IIIntelliVue Patient Monitor MX450. Model Number: 866062Philips North America LLCMHX
Z-1107-2025Class IIIntelliVue Patient Monitor MX400. Model Number: 866060Philips North America LLCMHX
Z-1106-2025Class IIIntelliBridge EC10 Module. Model Number: 865115Philips North America LLCMHX
Z-1174-2025Class IIDeRoyal AMG Suction Connector Tubing REF: 71-2083, 71-C506, 71-C510, 71-C512, 71-C520, Tu...DeRoyal Industries, Inc.BYY
Z-1071-2025Class IOlympus Single Use Guide Sheath Kits with the following product descriptions and model...OLYMPUS Corporation of the AmericasEOQ
Z-1074-2025Class IVaporizer Sevoflurane, Quik-Fil. Model Number: 6682285. Device is a component of Flow-i...Maquet Cardiovascular Us Sales, LLCBSZ
Z-1170-2025Class IIBrand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog...Hologic, Inc.KNW
Z-1066-2025Class IIInfinity Central Station. Model Number: MS26800 The Infinity CentralStation (ICS) is...Draeger Medical Systems, Inc.MHX
Z-1161-2025Class ICardio Vascular-Allura Centron; Catalog number: 722400 (OUS ONLY).Philips Medical Systems Nederland B.V.OWB
Z-1160-2025Class IAzurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);Philips Medical Systems Nederland B.V.OWB
Z-1159-2025Class IAzurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).Philips Medical Systems Nederland B.V.OWB
Z-1158-2025Class IAzurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236.Philips Medical Systems Nederland B.V.OWB
Z-1157-2025Class IAzurion 7 B12; Catalog numbers: (1) 722067, (2) 722225, (3) 722235 (OUS ONLY).Philips Medical Systems Nederland B.V.OWB
Z-1156-2025Class IAzurion 5 M20; Catalog numbers: (1) 722228, (2) 722232 (OUS ONLY), (3) 722281 (OUS ONLY).Philips Medical Systems Nederland B.V.OWB
Z-1155-2025Class IAzurion 5 M12; Catalog numbers: (1) 722227, (2) 722231 (OUS ONLY).Philips Medical Systems Nederland B.V.OWB
Z-1154-2025Class IAzurion 3 M15; Catalog numbers: (1) 722064, (2) 722222 (3) 722280(OUS ONLY).Philips Medical Systems Nederland B.V.OWB