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 131 of 1190
FDA device recalls, page 131 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2454-2024Class IISOFT-VU KUMPE 5F X 65CM -Used for patients in need of angiographic diagnosis. Catalog...Boston Scientific CorporationDQO
Z-2453-2024Class IISOFT-VU KUMPE 5F X 40CM -Used for patients in need of angiographic diagnosis. Catalog...Boston Scientific CorporationDQO
Z-2424-2024Class IIBD Nano 2nd Gen Pen Needles 32G X 4mm (5-count sample contained in Patient Counseling...Embecta Medical II LLCFMI
Z-3073-2024Class IIMedtronic Handset with Communicator, Model TH90Q01, InterStim Smart Programmer and...Medtronic NeuromodulationEZW
Z-2685-2024Class IIRegard Kit containing the Microtek decanterROi CPS LLCKPE
Z-2736-2024Class IIAfinion 2 Analyzer, model #1116986, US refurbished, CLIA waived.Abbott Diagnostics Technologies ASLCP
Z-2250-2024Class IBrand Name: MEGADYNE" MEGA SOFT" Dual Reusable Patient Return Electrode Product Name...Megadyne Medical Products, IncGEI
Z-2249-2024Class IBrand Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Product Name...Megadyne Medical Products, IncGEI
Z-2248-2024Class IBrand Name: MEGADYNE" MEGA 2000" Patient Return Electrode Product Name: MEGADYNE" MEGA...Megadyne Medical Products, IncGEI
Z-2404-2024Class IIOUTLOOK PUMP SET 3 CARESITE LADS 133 IN.-Used with an electrically-powered infusion pump...B Braun Medical IncFPA
Z-2403-2024Class IIInfusomat UNIV. 15 DROP PUMP SET, 3 ULTRASITE, ASV-Used with an electrically-powered...B Braun Medical IncFPA
Z-2402-2024Class IIOutlook OUTLOOK PUMP SET,3 CARESITE LADS,115 IN. Used with an electrically-powered...B Braun Medical IncFPA
Z-2401-2024Class IIInfusomat UNIV 60 DROP PUMP SET, W/2 CARESITE INJ. -Used with an electrically-powered...B Braun Medical IncFPA
Z-2400-2024Class IIInfusomat SPACE PUMP IV SET W/2 CARESITE, CKVLV -Used with an electrically-powered...B Braun Medical IncFPA
Z-2399-2024Class IIInfusomat UNIV. 15 DROP PUMP SET W/2 CARESITE CV- Used with an electrically-powered...B Braun Medical IncFPA
Z-2398-2024Class IIInfusomat 60 DROP METRISET PUMP SET, 3 CARESITES Used with an electrically-powered...B Braun Medical IncFPA
Z-2397-2024Class IIInfusomat UNIV. 15 DROP PUMP SET W 3 CARESITE L.L. Used with an electrically-powered...B Braun Medical IncFPA
Z-2396-2024Class IIInfusomat SPACE PUMP IV SET 15D, 90 IN. Used with an electrically-powered infusion pump...B Braun Medical IncFPA
Z-2395-2024Class IIInfusomat SPACE PUMP IV SET, 127 IN.-Used with an electrically-powered infusion pump for...B Braun Medical IncFPA
Z-2394-2024Class IIInfusomat SPACE PUMP IV SET 15D, 110 IN. -Used with an electrically-powered infusion...B Braun Medical IncFPA
Z-2393-2024Class IIInfusomat UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV-Used with an electrically-powered...B Braun Medical IncFPA
Z-2392-2024Class IIInfusomat UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV-Used with an electrically-powered...B Braun Medical IncFPA
Z-2391-2024Class IIInfusomat UNIV. 15 DR PUMP SET, 1.2FIL, 2CRSTE ASV-Used with an electrically-powered...B Braun Medical IncFPA
Z-2390-2024Class IIInfusomat UNIV. 60 DROP PUMP SET, 2 CARESITES, ASV-Used with an electrically-powered...B Braun Medical IncFPA
Z-2389-2024Class IIInfusomat 60DROP METRISET PUMP, 3 CARESITES, ASV-Used with an electrically-powered...B Braun Medical IncFPA
Z-2388-2024Class IIInfusomat UNIV. 15 DROP PUMP SET, 2 CARESITE, ASV-Used with an electrically-powered...B Braun Medical IncFPA
Z-2387-2024Class IIInfusomat SPACE PUMP IV SET, 2 CARESITES, ASV-Used with an electrically-powered infusion...B Braun Medical IncFPA
Z-2386-2024Class IIInfusomat UNIV. 15 DROP PUMP SET W/3 SAFELINE, ASV-Used with an electrically-powered...B Braun Medical IncFPA
Z-2385-2024Class IIInfusomat 60 DROP METRISET PUMP SET,3 SFLINE ASV-Used with an electrically-powered...B Braun Medical IncFPA
Z-2384-2024Class IIInfusomat SPACE PUMP IV SET , 120 IN.- Used with an electrically-powered infusion pump...B Braun Medical IncFPA
Z-2383-2024Class IIInfusomat UNIV. 15 DROP PUMP SET W/ 3 ULTRASITE LL-Used with an electrically-powered...B Braun Medical IncFPA
Z-2382-2024Class IIInfusomat SPACE PUMP SET 15 DROP W/2 SAFEDAY-Used with an electrically-powered infusion...B Braun Medical IncFPA
Z-2381-2024Class IIInfusomat UNIV. 15 DROP PUMP SET W/ 0.2 FILTER- Used with an electrically-powered...B Braun Medical IncFPA
Z-2380-2024Class IIInfusomat 60DROP METRISET PUMP SET, 3 SAFELINE-Used with an electrically-powered...B Braun Medical IncFPA
Z-2379-2024Class IIInfusomat UNIV. 15 DR PUMP SET, 1.2 FIL, 2 CRSITE-Used with an electrically-powered...B Braun Medical IncFPA
Z-2378-2024Class IIInfusomat UNIV.15DROP PUMP SET W/3 SAFELINE LL-Used with an electrically-powered...B Braun Medical IncFPA
Z-2377-2024Class IIOUTLOOK IV SET 15DROP W/3 CARESITE-Used with an electrically-powered infusion pump for...B Braun Medical IncFPA
Z-2376-2024Class IIOUTLOOK IV SET 15DROP W/2 CARESITE-Used with an electrically-powered infusion pump for...B Braun Medical IncFPA
Z-2530-2024Class IIBaxter SIGMA Spectrum Infusion Pump, Product Code: 35700BAX2Baxter Healthcare CorporationFRN
Z-2681-2024Class IIAlinity hq Analyzer, REF: 09P68-01Abbott MedicalGKZ
Z-2638-2024Class IIL-CATH PICC S/L Peripherally Inserted Central Catheter, 26Ga (1.9F) 0.60mm x 30cm, REF...Argon Medical Devices, IncLJS
Z-2545-2024Class IIDiscrete photometric chemistry analyzer for clinical use.Siemens Healthcare Diagnostics Inc.JJE
Z-2437-2024Class IIBrand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump...B Braun Medical IncFRN
Z-2436-2024Class IIBrand Name: Perfusor Space Product Name: PERFUSOR SPACE ACM-KIT Model/Catalog Number...B Braun Medical IncFRN
Z-2435-2024Class IIBrand Name: Perfusor Space Product Name: Perfusor PCA Syringe Pump Model/Catalog Number...B Braun Medical IncFRN
Z-2434-2024Class IIBrand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump...B Braun Medical IncFRN
Z-2433-2024Class IIBrand Name: Perfusor Space Product Name: Perfusor Space Infusion Pump...B Braun Medical IncFRN
Z-2484-2024Class IISIGNA MAGNUS, with affected software versions: MR29.1, RX29.1; Nuclear Magnetic...GE HealthcareLNH
Z-2483-2024Class IISIGNA 7.0T, with affected software versions: 7T29.1, MR30.1; Nuclear Magnetic Resonance...GE HealthcareLNH
Z-2482-2024Class IIDiscovery MR950, with affected software versions: 7T23.0; Nuclear Magnetic Resonance...GE HealthcareLNH