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 154 of 1190
FDA device recalls, page 154 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1614-2024Class IRoute 92 Medical 070 Reperfusion System, REF 1003, Rxonly, SterileEO. Used for...Route 92 Medical, Head QuartersDQY
Z-1613-2024Class IRoute 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, Sterile EO. Used for...Route 92 Medical, Head QuartersDQY
Z-1612-2024Class IRoute 92 Medical, 070 Access System, REF 1004, Rxonly , Sterile EO. Used for...Route 92 Medical, Head QuartersQJP
Z-1611-2024Class IRoute 92 Medical, Full Length 070 Reperfusion System, REF: 7001, Rxonly, SterileEO. Used...Route 92 Medical, Head QuartersNRY
Z-1610-2024Class IRoute 92 Medical Full Length 070 Access System, REF 7002, Rxonly, SterileEO. Used for...Route 92 Medical, Head QuartersQJP
Z-1533-2024Class IISTRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: STRATAFIX...Ethicon, IncGAM
Z-1701-2024Class IIPOWERSEAL 5 mm, 44 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use...OLYMPUS Corporation of the AmericasGEI
Z-1700-2024Class IIPOWERSEAL 5 mm, 37 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use...OLYMPUS Corporation of the AmericasGEI
Z-1699-2024Class IIPOWERSEAL 5 mm, 23 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use...OLYMPUS Corporation of the AmericasGEI
Z-1753-2024Class IIINNOMED CUP REMOVAL STARTER INSTRUMENT, REF 520054, Hip cutter blade cupInnomed, Inc.HWB
Z-1484-2024Class ILVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.Fresenius Kabi USA, LLCFRN
Z-1545-2024Class IICryoValve SG Cryopreserved Pulmonary Human Heart ValveArtivion, Inc.OHA
Z-1485-2024Class ITablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001Outset Medical, Inc.KDI
Z-1483-2024Class IIKWIK-STIK Rhizopus stolonifer (+) derived from ATCC 6227b, a) REF 0209P and b) REF 0209K...Microbiologics, Inc.JTR
Z-1477-2024Class IIstryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplastyWright Medical Technology IncHSN
Z-1425-2024Class IIExactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, Item number...Exactech, Inc.PHX
Z-1424-2024Class IIExactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b)...Exactech, Inc.PHX
Z-1423-2024Class IIExactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number...Exactech, Inc.PHX
Z-1422-2024Class IIExactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b)...Exactech, Inc.PHX
Z-1421-2024Class IIExactech Equinoxe Constrained Humeral Liner: Item Numbers: a) 320-40-10, b) 320-40-13...Exactech, Inc.PHX
Z-1420-2024Class IIExactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder...Exactech, Inc.PHX
Z-1419-2024Class IIExactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number...Exactech, Inc.PHX
Z-1418-2024Class IIExactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00...Exactech, Inc.PHX
Z-1417-2024Class IIExactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number...Exactech, Inc.PHX
Z-1416-2024Class IIExactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00...Exactech, Inc.PHX
Z-1415-2024Class IIExactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38...Exactech, Inc.KWS
Z-1414-2024Class IIExactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38...Exactech, Inc.KWS
Z-1413-2024Class IIExactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53...Exactech, Inc.KWS
Z-1412-2024Class IIExactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44...Exactech, Inc.KWS
Z-1411-2024Class IIExactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, RIGHT, FOR CEMENTED USE ONLY...Exactech, Inc.KWS
Z-1410-2024Class IIExactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, LEFT, FOR CEMENTED USE ONLY...Exactech, Inc.KWS
Z-1409-2024Class IIExactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, RIGHT, FOR CEMENTED USE ONLY...Exactech, Inc.KWS
Z-1408-2024Class IIExactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, LEFT, FOR CEMENTED USE ONLY...Exactech, Inc.KWS
Z-1407-2024Class IIExactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates with...Exactech, Inc.KWS
Z-1406-2024Class IIExactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, LEFT, Mates with: a)...Exactech, Inc.KWS
Z-1405-2024Class IIExactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a)...Exactech, Inc.KWS
Z-1404-2024Class IIExactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature...Exactech, Inc.KWS
Z-1403-2024Class IIExactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature...Exactech, Inc.KWS
Z-1402-2024Class IIExactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature...Exactech, Inc.KWS
Z-1759-2024Class IIClinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized...Randox Laboratories, LimitedJIX
Z-1609-2024Class It:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ...Tandem Diabetes Care, Inc.QFG
Z-1637-2024Class IIQUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20, 20 TestsOrtho-Clinical Diagnostics, Inc.PFQ
Z-1636-2024Class IIQUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20-U, 20 TestsOrtho-Clinical Diagnostics, Inc.PFQ
Z-1544-2024Class IINeria Soft Infusion Set, Product Code 507302, intravascular administration setUnomedical A/SFPA
Z-1488-2024Class IIBed Assist Bars, labeled as follows: a) Medline SwivAssist Bar, Model Number...MEDLINE INDUSTRIES, LP - NorthfieldQTC
Z-1487-2024Class IIBed Assist Bars, labeled as follows: a) Medline, Model Number BA6800, b) Medline...MEDLINE INDUSTRIES, LP - NorthfieldQTC
Z-1400-2024Class IIHill-Rom PRO+ 36" MRS Surface, REF P7924A03, The pro+ mattress is intended for patient...Baxter Healthcare CorporationIOQ
Z-1546-2024Class IIDxI 9000 Access Immunoassay Analyzer, REF C11137, vitro diagnostic device used for the...Siemens Healthcare Diagnostics Inc.JJE
Z-1396-2024Class IIOptiCross Coronary Imaging Catheter, REF H749518080120Boston Scientific CorporationOBJ
Z-2037-2024Class IIINEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions...Halyard HealthKYX