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 52 of 1190
FDA device recalls, page 52 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0851-2026Class IIIntelliVue MP20. Product Number: M8001A.Philips North America LLCDSI
Z-0850-2026Class IIIntelliVue MP5. Product Number: M8105A.Philips North America LLCDSI
Z-0849-2026Class IIIntelliVue MP2. Product Number: M8102A.Philips North America LLCDSI
Z-0874-2026Class IIOlympus OER-MiniAizu Olympus Co., Ltd.FEB
Z-0873-2026Class IIOlympus OER-ProAizu Olympus Co., Ltd.FEB
Z-0872-2026Class IIOlympus OER-EliteAizu Olympus Co., Ltd.FEB
Z-0883-2026Class IILumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,Philips North America LLCIYN
Z-0601-2026Class IINICO BrainPath; Product Number/Product Name NN-8024 BrainPath Shephard's Hook...Stryker Corp.GEI
Z-0600-2026Class IINICO Myriad Illumination Pack Product No. NN-1000 11g Illumination Sleeve/Fiber; Product...Stryker Corp.GEI
Z-0599-2026Class IINICO Myriad Handpiece Product Number/Product Name: NN-8000 15x10 MHP; NN-8001 15x 13...Stryker Corp.GEI
Z-0960-2026Class IIBrand Name: Xpert BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10CepheidOYX
Z-0959-2026Class IIBrand Name: Xpert BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10CepheidOYX
Z-0596-2026Class IIFlexLab (FLX); Version: FLX-217-40;Inpeco S.p.A.CEM
Z-0595-2026Class IIFlexLab (FLX); Version: FLX-217-10;Inpeco S.p.A.CEM
Z-0570-2026Class IBrand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Model/Catalog...OLYMPUS Corporation of the AmericasMND
Z-1039-2026Class IIMedicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174Medicrea InternationalMAX
Z-1038-2026Class IIMedicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000Medicrea InternationalMAX
Z-0943-2026Class II1ml of DTT in liquid phase, in PET tube with capture cap, in bulkCopan ItaliaPPM
Z-0942-2026Class II1ml of DTT in liquid phase, in PET tube with capture cap, in bulk + sputum transfer...Copan ItaliaPPM
Z-0882-2026Class IICT 5300; Software Version Number: 4.5, 5.0, 5.1;Philips North America LLCJAK
Z-0881-2026Class IIIncisive CT; Software Version Number: 4.5, 5.0, 5.1;Philips North America LLCJAK
Z-0726-2026Class IIAurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter...Medtronic, Inc.LWS
Z-0718-2026Class IIIV Administration Set utilized in gravity IV administration sets and pump administration...B Braun Medical IncFPA
Z-0717-2026Class IIIV Administration Set utilized in gravity IV administration sets and pump administration...B Braun Medical IncFMG
Z-0716-2026Class IIOutlook set utilized in gravity IV administration sets and pump administration sets...B Braun Medical IncFPA
Z-0715-2026Class IIVista set utilized in gravity IV administration sets and pump administration sets...B Braun Medical IncFPA
Z-0714-2026Class IIULTRASITE set utilized in gravity IV administration sets and pump administration sets...B Braun Medical IncFPA
Z-0713-2026Class IISAFELINE set utilized in gravity IV administration sets and pump administration sets...B Braun Medical IncFPA
Z-0712-2026Class IISafeDAY set utilized in gravity IV administration sets and pump administration sets...B Braun Medical IncFPA
Z-0711-2026Class IISafeDAY set utilized in gravity IV administration sets and pump administration sets...B Braun Medical IncFPA
Z-0710-2026Class IIRATE FLOW set utilized in gravity IV administration sets and pump administration sets...B Braun Medical IncFPA
Z-0709-2026Class IIOutlook set utilized in gravity IV administration sets and pump administration sets...B Braun Medical IncFPA
Z-0708-2026Class IIOutlook set utilized in gravity IV administration sets and pump administration sets...B Braun Medical IncFMG
Z-0707-2026Class IIOutlook set utilized in gravity IV administration sets and pump administration sets...B Braun Medical IncFPA
Z-0706-2026Class IIOutlook set utilized in gravity IV administration sets and pump administration sets...B Braun Medical IncFPA
Z-0705-2026Class IIIV Administration Set utilized in gravity IV administration sets and pump administration...B Braun Medical IncFPA
Z-0704-2026Class IIIV Administration Set utilized in gravity IV administration sets and pump administration...B Braun Medical IncFPA
Z-0703-2026Class IIIV Administration Set utilized in gravity IV administration sets and pump administration...B Braun Medical IncFPA
Z-0702-2026Class IIIV Administration Set utilized in gravity IV administration sets and pump administration...B Braun Medical IncFPA
Z-0701-2026Class IIIV Administration Set utilized in gravity IV administration sets and pump administration...B Braun Medical IncFPA
Z-0700-2026Class IIIV Administration Set utilized in gravity IV administration sets and pump administration...B Braun Medical IncFPA
Z-0699-2026Class IIIV Administration Set utilized in gravity IV administration sets and pump administration...B Braun Medical IncFPA
Z-0698-2026Class IIIV Administration Set utilized in gravity IV administration sets and pump administration...B Braun Medical IncFPA
Z-0697-2026Class IIIV Administration Set utilized in gravity IV administration sets and pump administration...B Braun Medical IncFPA
Z-0696-2026Class IIIV Administration Set utilized in gravity IV administration sets and pump administration...B Braun Medical IncFPA
Z-0695-2026Class IIIV Administration Set utilized in gravity IV administration sets and pump administration...B Braun Medical IncFPA
Z-0694-2026Class IIIV Administration Set utilized in gravity IV administration sets and pump administration...B Braun Medical IncFPA
Z-0693-2026Class IIIV Administration Set utilized in gravity IV administration sets and pump administration...B Braun Medical IncFPA
Z-0692-2026Class IIIV Administration Set utilized in gravity IV administration sets and pump administration...B Braun Medical IncFPA
Z-0691-2026Class IIIV Administration Set utilized in gravity IV administration sets and pump administration...B Braun Medical IncFPA