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 97 of 1190
FDA device recalls, page 97 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1153-2025Class IAzurion 3 M12; Catalog numbers: (1) 722063, (2) 722221.Philips Medical Systems Nederland B.V.OWB
Z-1152-2025Class IAllura Xper FD10C; Catalog number: 722001Philips Medical Systems Nederland B.V.OWB
Z-1151-2025Class IAllura CV20; Catalog numbers: 722031Philips Medical Systems Nederland B.V.OWB
Z-1150-2025Class IAllura Xper FD20/20; Catalog numbers: 722038Philips Medical Systems Nederland B.V.OWB
Z-1149-2025Class IAllura Xper FD20/15; Catalog numbers: 722058Philips Medical Systems Nederland B.V.OWB
Z-1148-2025Class IAllura Xper FD20/10; Catalog numbers: 722029Philips Medical Systems Nederland B.V.OWB
Z-1147-2025Class IAllura Xper FD20 OR Table; Catalog numbers: (1) 722023, (2) 722035.Philips Medical Systems Nederland B.V.OWB
Z-1146-2025Class IAllura Xper FD20 Biplane OR Table; Catalog numbers: (1) 722020, (2) 722025.Philips Medical Systems Nederland B.V.OWB
Z-1145-2025Class IAllura Xper FD20 Biplane; Catalog numbers: (1) 722008, (2) 722013.Philips Medical Systems Nederland B.V.OWB
Z-1144-2025Class IAllura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.Philips Medical Systems Nederland B.V.OWB
Z-1143-2025Class IAllura Xper FD10/10; Catalog numbers: (1) 722005, (2) 722011, (3) 722027.Philips Medical Systems Nederland B.V.OWB
Z-1142-2025Class IAllura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,Philips Medical Systems Nederland B.V.OWB
Z-1094-2025Class IIAzurion 7 M20 System code: (1) 722224 (2) 722079 (3) 722234 (4) 722282 System...Philips Medical Systems Nederland B.V.OWB
Z-1093-2025Class IIAzurion 7 M12 System Code: (1) 722078 (2) 722223 (3) 722233Philips Medical Systems Nederland B.V.OWB
Z-1092-2025Class IIAzurion 7 B20 System Code: (1) 722068 (2) 722226 (3) 722236Philips Medical Systems Nederland B.V.OWB
Z-1091-2025Class IIAzurion 7 B12 System Code: (1) 722067 (2) 722225 (3) 722235Philips Medical Systems Nederland B.V.OWB
Z-1090-2025Class IIAzurion 5 M20 System Code: (1) 722228 (2) 722232 (3) 722281Philips Medical Systems Nederland B.V.OWB
Z-1089-2025Class IIAzurion 5 M12 System Code: (1) 722227 (2) 722231Philips Medical Systems Nederland B.V.OWB
Z-1088-2025Class IIAzurion 3 M15 System Code: (1) 722064 (2) 722222 (3) 722280Philips Medical Systems Nederland B.V.OWB
Z-1087-2025Class IIAzurion 3 M12 System Code: (1) 722063 (2) 722221Philips Medical Systems Nederland B.V.OWB
Z-1086-2025Class IIAlluraXperFD20/15 System Code: (1) 722058Philips Medical Systems Nederland B.V.OWB
Z-1085-2025Class IIAllura Xper FD20/20 System Code: (1) 722038Philips Medical Systems Nederland B.V.OWB
Z-1084-2025Class IIAlluraXperFD20/10 System Code: (1) 722029Philips Medical Systems Nederland B.V.OWB
Z-1083-2025Class IIAlluraXper FD20 OR Table System Code: (1) 722023 (2) 722035Philips Medical Systems Nederland B.V.OWB
Z-1082-2025Class IIAlluraXper FD20 Biplane OR Table System Code: (1) 722020 (2) 722025Philips Medical Systems Nederland B.V.OWB
Z-1081-2025Class IIAlluraXper FD20 Biplane System Code: (1) 722008 (2) 722013Philips Medical Systems Nederland B.V.OWB
Z-1080-2025Class IIAlluraXper FD20 System Code: (1) 722006 (2) 722012 (3) 722028Philips Medical Systems Nederland B.V.OWB
Z-1079-2025Class IIAllura Xper FD10C System Code: (1) 722001Philips Medical Systems Nederland B.V.OWB
Z-1078-2025Class IIAlluraXper FD10/10 System Code: (1) 722005 (2) 722011 (3) 722027Philips Medical Systems Nederland B.V.OWB
Z-1077-2025Class IIAllura Xper FD10 Catalog (1) 722003 (2) 722010 (3)722026Philips Medical Systems Nederland B.V.OWB
Z-1076-2025Class IIAllura CV20 System Code: 722031Philips Medical Systems Nederland B.V.OWB
Z-1233-2025Class IIDxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software.Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.JJE
Z-1206-2025Class IIBD Pyxis: MedFlex, REF: 1119-00; MedBank Tower REF: 1145-00; MedBank MedPass, REF...CareFusion 303, IncBRY
Z-1168-2025Class IIBrand Name: MediHoney Gel Product Name: MediHoney Wound & Burn Dressing Gel Model/Catalog...Integra LifeSciences CorporationFRO
Z-1070-2025Class IIntact Vascular Tack Endovascular System, to treat vascular dissections with Tack...Spectranetics Corp.QCT
Z-1019-2025Class IIvenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital...Fresenius Kabi USA, LLCFRN
Z-1101-2025Class II. Nobel Biocare N1 TiUltra TCC RP 4.0x9mm . Nobel Biocare N1 TiUltra TCC RP 4.0x11mm...Nobel Biocare ABDZE
Z-1506-2025Class IIA820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion...Medtronic NeuromodulationLKK
Z-1269-2025Class IICircuitGuard Bacterial/Viral Filter with Elbow (Model/Catalogue number: SK200FPE / 7056)Kung Shin Plastics Co. Ltd.CAH
Z-1268-2025Class IICircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral...Kung Shin Plastics Co. Ltd.CAH
Z-1183-2025Class IIMedline Convenience Kits for Various Procedures: 1) CLOVIS RESP/INTUB DRAWER 2, Model...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-1182-2025Class IIMedline Convenience Kits for Various Procedures: 1) ADULT INTUBATION TRAY, Model Number...MEDLINE INDUSTRIES, LP - NorthfieldCAI
Z-1100-2025Class IIThe MSOT Acuity Echo is a Class 4 medical laser device. The MSOT Acuity is a mobile...Ithera Medical GmbHREK
Z-1230-2025Class II139088-01 Bd Pyxis Medbank Medpass Module 169-151 Bd Pyxis Medbank Mini 1Fh-2Hh Medpass...CareFusion 303, IncBRY
Z-1229-2025Class II139054-01 Bd Pyxis Medflex Mn 1000 10Hh-1Fm 139055-01 Bd Pyxis Medflex Mn 1000 12Hh...CareFusion 303, IncBRY
Z-1228-2025Class II155288-01 Bd Pyxis Medbank Mini 1Fh-1Fm 169-137 Bd Pyxis Medbank Mini 1Fh-1Fm 155311-01...CareFusion 303, IncBRY
Z-1227-2025Class II138913-01 Bd Pyxis Medbank Mini Cr-2Hh-1Fh-P 169-114 Bd Pyxis Medbank Mini Cr-2Hh-1Fh-P...CareFusion 303, IncBRY
Z-1095-2025Class IIThe Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the Rapid fFN...Hologic, Inc.LIO
Z-1139-2025Class IIstryker Precision Thin, Catalog Number REF 2296-003-155; Micro Oscillating and Sagittal...Stryker Corp.GEI
Z-1138-2025Class IIstryker Precision Thin, Catalog Number REF 2296-003-108; Micro Oscillating and Sagittal...Stryker Corp.GEI