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 335 of 1190
FDA device recalls, page 335 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2739-2020Class IIMatrixMIDFACE Screws - Product Usage: The intended use for this device is in fixation of...SYNTHES GmbH / Synthes Produktions GmbHJEY
Z-2589-2020Class IBodyGuard Microset w/ 0.2 mic filter and lower y-site with female luer, REF: A120-160CYFRVCME America, LLCFPA
Z-2588-2020Class IBodyGuard Microset With Female Luer, REF: A120-160XPSNCME America, LLCFPA
Z-2587-2020Class ICMExpress Needleless Y Site Microbore Set, REF: A120-160CYNVKCME America, LLCFPA
Z-2586-2020Class ICMExpress Microbore Set, REF: A120-160CCME America, LLCFPA
Z-2585-2020Class IStandard BodySet with Needleless Connectors, REF: A120-125XSCME America, LLCFPA
Z-2584-2020Class IBodyGuard Microset w/ 0.2 mic filter and lower y-site with female luer, REF: A120-160XYBFCME America, LLCFPA
Z-2583-2020Class IBodyGuard Microset with Filter and Manual Priming Valve, REF: A120-112XSFVCME America, LLCFPA
Z-2582-2020Class IBodyGuard set with Female Luer, REF: A120-003XSNCME America, LLCFPA
Z-2581-2020Class IBodyGuard Microset with Male Luer Connectors, REF: A100-163XEBFCME America, LLCFPA
Z-2580-2020Class ICMExpress Microbore Sets, REF: A120-161CCME America, LLCFPA
Z-2579-2020Class ICMExpress Microbore Sets, REF: A120-160C2YRVCME America, LLCFPA
Z-2578-2020Class ICMExpress Microbore Sets, REF: A120-160CYFRVCME America, LLCFPA
Z-2577-2020Class IBodyGuard Microset, REF: A120-160GCFACME America, LLCFPA
Z-2576-2020Class IBodyGuard Microset, REF: A120-125XSECME America, LLCFPA
Z-2575-2020Class IBodyGuard Microset, REF: A120-003XS2YVCME America, LLCFPA
Z-2574-2020Class IBodyGuard Microset, REF: A100-163XSLCME America, LLCFPA
Z-2573-2020Class IBodyGuard Microset, REF: A100-163XE90SCME America, LLCFPA
Z-2572-2020Class IBodyGuard Microset with Filter, REF: A100-164XESFCME America, LLCFPA
Z-2571-2020Class IBodyGuard Microset with Filter, REF: A120-160XSFECME America, LLCFPA
Z-2570-2020Class IBodyGuard Microset w/ Non-Vented Spike Connector, REF: A100-163XEBSCME America, LLCFPA
Z-2569-2020Class ICMExpress Microbore Set, REF: A120-161CYFCME America, LLCFPA
Z-2568-2020Class ICMExpress Microbore Set, REF: A120-160CRVCME America, LLCFPA
Z-2567-2020Class IBodyGuard Microset with Needleless Adaptor, REF: A120-003XSNYCME America, LLCFPA
Z-2566-2020Class IBodyGuard Microset, REF: A120-160X2YBCME America, LLCFPA
Z-2565-2020Class IBodyGuard Microset, REF: A120-161XPSVCME America, LLCFPA
Z-2564-2020Class IBodyGuard Microset with Filter, REF: A100-163XESFCME America, LLCFPA
Z-2563-2020Class IBodyGuard Microset, REF: A120-161XYBSCME America, LLCFPA
Z-2562-2020Class IBodyGuard Microset, REF: A120-161XYBCME America, LLCFPA
Z-2561-2020Class IBodyGuard Microset, REF: A120-160XYSFCME America, LLCFPA
Z-2560-2020Class IBodyGuard Microset, REF: A100-163XSFLCME America, LLCFPA
Z-2559-2020Class IBodyGuard Microset, REF: A120-112XSFKCME America, LLCFPA
Z-2558-2020Class IBodyGuard Microset, REF: A120-160XSFKCME America, LLCFPA
Z-2557-2020Class IBodyGuard Microset, REF: A120-161XPSCME America, LLCFPA
Z-2556-2020Class IBodyGuard Microset, REF: A100-163XESCME America, LLCFPA
Z-2555-2020Class IBodyGuard Microset, REF: A100-163XESVCME America, LLCFPA
Z-2554-2020Class IBodyGuard Microset, REF: A120-160XPSCME America, LLCFPA
Z-2553-2020Class IBodyGuard BodySet, REF: A120-160SASCME America, LLCFPA
Z-2776-2020Class IIVerigene Processor SP with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic...Luminex CorporationPEN
Z-2775-2020Class IIVerigene Processor SP with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic...Luminex CorporationPAM
Z-2550-2020Class IIIPOWERWAND XL 4Fr 8cm Maximum Barrier Kit (Introducer with an Extended Dwell Catheter made...Access Scientific, Inc.OWL
Z-2673-2020Class IISoftware 1898072 IPC upgrade v 2.7.3.0 - Product Usage: The IPC system is indicated for...Medtronic Xomed, Inc.ERL
Z-2499-2020Class IIPORT-A-CATH II POWER P.A.C. Low Profile" system.Abbott MedicalLJT
Z-2684-2020Class IINuvasive NVM5 EMG Module, REF 8020015, Rx ONLY, CE2797, Nonsterile, UDI: 00887517206633...NuVasive IncPDQ
Z-2442-2020Class IILeksell Vantage Stereotactic System, UDI/GTIN 7340048304887Elekta Instrument ABHAW
Z-2950-2020Class IIION Reprocessing Accessories Kit, IF1000 (Part Number: 490024-03) UDI:00886874119129. The...Intuitive Surgical, Inc.EOQ
Z-2949-2020Class IIIon Catheter Reprocessing Cover, IF1000 (Part Number:490114-02) UDI:00886874116845.Intuitive Surgical, Inc.EOQ
Z-2486-2020Class IIPERMA-HAND/MERSILK SILK BLU and VIRGIN SILK BLU, Product Codes...Ethicon, IncGAP
Z-2640-2020Class IIExpansion Control Overlay, Item No. 1004EC - Product Usage: The EHOB WAFFLE Overlay is...EHOB, Inc.FMP
Z-2552-2020Class IIenVista one-piece hydrophobic acrylic toric intraocular lens, Bausch and Lomb - Product...Bausch & Lomb IncorporatedHQL