510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK 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

59,486 records, page 346 of 1190
FDA device recalls, page 346 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2624-2020Class IISK SKAFFOLD IMPRESS 10CC. Product Number: SKAF-IM10, UDI: 813845020795 - Product Usage...Skeletal Kinetics, LLCMQV
Z-2623-2020Class IIOSTEOVATIONEX, INJECT 3CC. Product Number: 390-0003, UDI: 813845020016 - Product Usage...Skeletal Kinetics, LLCMQV
Z-2622-2020Class IIOSTEOVATIONEX 5CC, INJECT FORMULA. Product Number: 390-0005, UDI: 813845020023 - Product...Skeletal Kinetics, LLCMQV
Z-2621-2020Class IIOSTEOVATIONEX 2CC INJECT FORMULA. Product Number: 390-0002, UDI: 813845020009 - Product...Skeletal Kinetics, LLCMQV
Z-2620-2020Class IIOSTEOVATION, 5CC, INJECT FORMULA. Product Number: 390-2005, UDI: 813845020054 - Product...Skeletal Kinetics, LLCMQV
Z-2619-2020Class IIOSTEOVATION, 5CC, IMPACT FORMULA. Product Number: 390-2105, UDI: 813845020085 - Product...Skeletal Kinetics, LLCGXP
Z-2618-2020Class IIOSTEOVATION, 3CC, IMPACT FORMULA. Product Number: 390-2103, UDI: 813845020078 - Product...Skeletal Kinetics, LLCGXP
Z-2617-2020Class IIOSTEOVATION, 10CC, INJECT FORMULA. Product Number: 390-2010, UDI: 813845020061 - Product...Skeletal Kinetics, LLCGXP
Z-2616-2020Class IIOSTEOVATION RMX 5CC. Product Number: 390-6001, UDI: 813845021082 - Product Usage: Callos...Skeletal Kinetics, LLCGXP
Z-2615-2020Class IIOSTEOVATION RMX 10CC. Product Number: 390-6002, UDI: 813845021099 - Product Usage: Callos...Skeletal Kinetics, LLCGXP
Z-2614-2020Class IIOSTEOVATION IMPACT 10CC and OSTEOVATION, 10CC, IMPACT FORMULA, Product Number...Skeletal Kinetics, LLCGXP
Z-2613-2020Class IIOSTEOVATION EX, 5CC, IMPACT FORMULA. Product Number: 390-0205, UDI: 813845020047...Skeletal Kinetics, LLCMQV
Z-2612-2020Class IIOSTEOVATION EX, 3CC, IMPACT FORMULA. Product Number: 390-0203, UDI: 813845020030...Skeletal Kinetics, LLCMQV
Z-2611-2020Class IIMEDTRONIC BONE VOID FILLER, SMALL. Product Number: C07A, UDI: 813845020504 - Product...Skeletal Kinetics, LLCMQV
Z-2610-2020Class IIMEDTRONIC BONE VOID FILLER, LARGE. Product Number: C07B, UDI: 813845020511 - Product...Skeletal Kinetics, LLCMQV
Z-2609-2020Class IIEXACTECH OSSILIX FORM (MX), 5CC. Product Number: 660-01-05, UDI: 813845021020 - Product...Skeletal Kinetics, LLCMQV
Z-2608-2020Class IIEXACTECH OSSILIX FORM (MX), 10CC. Product Number: 660-01-10, UDI: 813845021037 - Product...Skeletal Kinetics, LLCMQV
Z-2607-2020Class IIEXACTECH OSSILIX FIL (MX), 5CC. Product Number: 660-02-05, UDI: 813845021006 - Product...Skeletal Kinetics, LLCMQV
Z-2606-2020Class IIEXACTECH OSSILIX FIL (MX), 10CC. Product Number: 660-02-10, UDI: 813845021013 - - Product...Skeletal Kinetics, LLCMQV
Z-2605-2020Class IICRANIOSCULPT, FLOW 5CC. Product Number: C-FLOW5CC, UDI: 813845020337 - Product Usage...Skeletal Kinetics, LLCGXP
Z-2604-2020Class IICRANIOSCULPT FLOW, OUS, 5CC Product Number: C-FLOW5CC-OUS, UDI: 813845020351 - Product...Skeletal Kinetics, LLCGXP
Z-2603-2020Class IICRANIOSCULPT FLOW, OUS, 10CC. Product Number: C-FLOW10CC-OUS, UDI: 813845020382 - Product...Skeletal Kinetics, LLCGXP
Z-2602-2020Class IICRANIOSCULPT FLOW, CAN, 5CC. Product Number: C-FLOW5CC-CAN, UDI: 813845020344 - Product...Skeletal Kinetics, LLCGXP
Z-2601-2020Class IICRANIOSCULPT FLOW, 10CC. Product Number: C-FLOW10CC, UDI: 813845020368 - - Product Usage...Skeletal Kinetics, LLCGXP
Z-2600-2020Class IICRANIOSCULPT FLOW, 3CC. Product Number: C-FLOW3CC, UDI: 813845020320 - - Product Usage...Skeletal Kinetics, LLCGXP
Z-2599-2020Class IICRANIOSCULPT C, 5CC. Product Number: C-C5CC, UDI: 813845021112 - - Product Usage: Callos...Skeletal Kinetics, LLCGXP
Z-2598-2020Class IICRANIOSCULPT C, 3CC. Product Number: C-C3CC, UDI: 813845021105 - Product Usage: Callos is...Skeletal Kinetics, LLCGXP
Z-2597-2020Class IICRANIOSCULPT C, 10CC. Product Number: C-C10CC, UDI: 813845021129 - Product Usage: Callos...Skeletal Kinetics, LLCGXP
Z-2596-2020Class IIACUMED IMPACT 5CC. Product Number: 65-0105-S, UDI: 813845020252 - Product Usage: Callos...Skeletal Kinetics, LLCMQV
Z-2595-2020Class IIACUMED IMPACT 10CC. Product Number: 65-0110-S, UDI: 813845020269 - Callos is indicated to...Skeletal Kinetics, LLCMQV
Z-2594-2020Class IIACUMED CALLOS INJECT 5CC. Product Number: 65-0005-S, UDI: 813845020238 - Product Usage...Skeletal Kinetics, LLCMQV
Z-2593-2020Class IIACUMED CALLOS INJECT 3CC. Product Number: 65-0003-S, UDI: 813845020221 - Product Usage...Skeletal Kinetics, LLCMQV
Z-2202-2020Class IIAGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic, Type number: 6010/200...Agfa N.V.JAA
Z-2592-2020Class IIACUMED CALLOS INJECT 10CC. Product Number: 65-0010-S, UDI: 813845020245 - Product Usage...Skeletal Kinetics, LLCMQV
Z-1923-2020Class IIPhilips Brilliance IQon Spectral CT, Computed Tomography X-Ray System; Model # 728332...Philips North America LLCJAK
Z-1922-2020Class IIPhilips Brilliance iCT SP Computed Tomography X-Ray System; Model # 728311Philips North America LLCJAK
Z-1921-2020Class IIPhilips Brilliance iCT Computed Tomography X-Ray System; Model # 728306; UDI #s...Philips North America LLCJAK
Z-1765-2020Class IISystem AXIOM Aristos FX Plus - A dedicated x-ray system with a flat panel detector which...Siemens Medical Solutions USA, Inc.MQB
Z-1764-2020Class IISystem AXIOM Aristos FX - Product Usage: A dedicated x-ray system with a flat panel...Siemens Medical Solutions USA, Inc.KPR
Z-2038-2020Class IIIOrthopedic manual Surgical Instrument handle for Simple Locking Intra Medullary (SLIM)...Orthopediatrics Canada ULCLXH
Z-2054-2020Class IICranio/Sculpt C, 10cc, Bone Void Filler, UDI: 00813845021129 - Product Usage...Skeletal Kinetics, LLCGXP
Z-2041-2020Class IIIImmersiveView software version 2.1 Product Usage: ImmersiveView is intended as...ImmersiveTouch, Inc.LLZ
Z-2116-2020Class IIVACUETTE Blood Transfer Unit. Lot no. A19024NX. Expiration date: 2022-02-07 - Product...C.A. Greiner & Sohne GesellschaftmbhJKA
Z-2059-2020Class IHeartware HVAD Pump Implant accessories, Product (REF) Number 1153HeartWare, Inc.DSQ
Z-2058-2020Class IHeartware HVAD Pump Outflow Graft, Product (REF) Number 1125HeartWare, Inc.DSQ
Z-1809-2020Class IIPhilips Azurion 7 M20 -XperGuide Software hosted in Interventional Workspot 1.5 when used...Philips North America LLCOWB
Z-2057-2020Class IHeartware HVAD Pump Implant Kit, Product (REF) Number 1104JPHeartWare, Inc.DSQ
Z-2056-2020Class IHeartware HVAD Pump Implant Kit, Product (REF) Number 1104HeartWare, Inc.DSQ
Z-2055-2020Class IHeartware HVAD Pump Implant Kit, Product (REF) Number 1103HeartWare, Inc.DSQ
Z-2191-2020Class IIOSTEOVATION RMX 10 CC Injectable. REF/UDI: 390-6002/ /00813845021099 - Product Usage: The...OsteomedMQV