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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 378 of 1190
FDA device recalls, page 378 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2504-2020Class IICEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H8mm, Part #018.1908.CTL Medical CorporationMAX
Z-2503-2020Class IICEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H8mm, Part #018.1308.CTL Medical CorporationMAX
Z-2502-2020Class IICEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H7mm, Part #018.1907.CTL Medical CorporationMAX
Z-2501-2020Class IICEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H7mm, Part #018.1307.CTL Medical CorporationMAX
Z-0533-2020Class IIBIOMOD PORCOAT HA GLENTRAY; Custom Shoulder Products Item Nos...Zimmer GmbHMBF
Z-0532-2020Class IILT DISC ULNA - HA/PC; RT DISC ULNA - HA/PC; LT DISC HMRL- HA/PC; RT DISC HMRL...Zimmer GmbHPIX
Z-0531-2020Class II2.0MM BALL NOSE GUIDE WIRE, Item Nos. 281017006 - Product Usage: These instruments and...Zimmer GmbHFZX
Z-0530-2020Class IIBALL NOSE GUIDE WIRE 80CM, 100CM. Item Nos. 281001080 281001100 Product Usage: These...Zimmer GmbHFZX
Z-0529-2020Class IIGUIDE WIRE 2.2MM X 28IN, Aim/Art Guide wire, Item No. 809222028 - Product Usage: These...Zimmer GmbHFZX
Z-0528-2020Class IIHA Pins (DFS HA Cort Screw), Hoffman/Colles Pins (Colles CSER Sterile w/ Pin Kit) Item...Zimmer GmbHKTT
Z-0527-2020Class IICopeland HA Resurfacing Head, MB/HA EAS Head; Item Nos...Zimmer GmbHMBF
Z-0526-2020Class IIVarious Custom Products, Item Nos. CP102940 CP102941 CP102942 CP102943 CP102944 CP102945 C...Zimmer GmbHNA
Z-0525-2020Class IIComprehensive RS Cleat CAP, Item No. 110300Zimmer GmbHNA
Z-0524-2020Class IIComprehensive HHR Tess Cleat, Item Nos. 110260 110261 110262 110263 Product Usage: N/AZimmer GmbHNA
Z-0523-2020Class IIVarious Hip systems, Item Nos. 104207 104212 104215 11-162809 11-162810 11-162811 11-16281...Zimmer GmbHLPH
Z-0522-2020Class IIHENNESSY LEFT CONST GLENOID HA, Item No. PM555360 UDI (01)00880304819597(17)260425(10)6640...Zimmer GmbHNA
Z-0521-2020Class IIACROMIUM FLANGE SET (Custom product) Item No. PM555148 - Product Usage: Arcomium...Zimmer GmbHNA
Z-0520-2020Class IICOMP RVRS Shoulder Baseplates, including Custom Products, Item numbers...Zimmer GmbHKWS
Z-0519-2020Class IICompress, Mini Compress; Item Nos. 178350 178351 178352 178353 178354 178355 178356 178357...Zimmer GmbHKWY
Z-2762-2019Class IISidus Stem-Free Shoulder Humeral Head 50-18 Item number: 01.04555.500 orthopedic implant...Zimmer GmbHPKC
Z-0040-2020Class IICanGaroo Envelopes labeled as the following: 1. CanGaroo Envelope (Large) (single...Boston Scientific CorporationFTM
Z-0039-2020Class IIBioEnvelope, surgical mesh envelope. Labeled as the following: 1. BioEnvelope...Boston Scientific CorporationFTM
Z-2543-2019Class IISubcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI...Boston Scientific CorporationLWS
Z-2542-2019Class IISubcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEMTM...Boston Scientific CorporationLWS
Z-1448-2020Class IIIFilmArray NGDS Warrior Panel, Ref: NGDS-ASY-0007, UDI: (01)00851458005136, IVD, Rx OnlyBioFire Defense, LLCPRD
Z-0037-2020Class IITxRx Knee 15 Coil 1.5T QED part number: Q7000057 Siemens Model # 10606829Quality ElectrodynamicsMOS
Z-0036-2020Class IITxRx Knee 15 Coil 1.5T QED part number: Q7000056 Siemens Model # 10606828Quality ElectrodynamicsMOS
Z-0035-2020Class IITxRx 15CH Knee Coil 3T QED part number: Q7000051 Siemens Model # 10606525Quality ElectrodynamicsMOS
Z-0034-2020Class IITxRx 15CH Knee Coil 1.5T QED part number: Q7000050 Siemens Model # 10606524Quality ElectrodynamicsMOS
Z-0033-2020Class IITxRx CP Extremity Coil 3T QED part number: Q7000019 Siemens Model # 10185464Quality ElectrodynamicsMOS
Z-0032-2020Class IITxRx 15CH Knee Coil 1.5T QED part number:Q7000016 Siemens Model # 10185453Quality ElectrodynamicsMOS
Z-0031-2020Class IITxRx 15Ch Knee Coil 3T QED part number:Q7000008 Siemens Model # 10185460Quality ElectrodynamicsMOS
Z-0051-2020Class II20" 2-Needle 26-Gauge 6mm HlgH-Flo Subcutaneous Safety Needle Sets" Product # RMS22606...Repro-Med Systems, Inc.FPA
Z-2131-2020Class IIda Vinci SP Camera; PN 430060-33; Model Number: 430060-33. For endoscopic surgery.Intuitive Surgical, Inc.NAY
Z-1443-2020Class IIRespVent Closed Suction System T-Piece Tracheostomy Adult, Diameter: 4.6mm (14F), Length...Respiratory Therapeutics Group LLCBSY
Z-0219-2020Class IIModel No. 01-1503-0032 (Adolescent Nail Attachment Bolt). Component of the Pediatric...Orthopediatrics CorpHSB
Z-0218-2020Class IIModel No. 01-1501-0032 (Child Nail Attachment Bolt). Component of the Pediatric Nailing...Orthopediatrics CorpHSB
Z-0125-2020Class IIOrthoPediatrics Adolescent attachment bolt used with the Pediatric Nailing Platform...Orthopediatrics CorpHSB
Z-2545-2019Class IIILEEP Return Patient Pads (10/ box) Model # 6050Pl used in electrosurgical procedures.CooperSurgical, Inc.GEI
Z-0074-2020Class IIBD FACSLyric Flow Cytometer, 3-Laser 12 Color Instrument, REF: 663029, when using BD...Becton, Dickinson and Company, BD BiosciencesOYE
Z-0073-2020Class IIBD FACSLyric Flow Cytometer,3-Laser 10 Color Instrument, REF: 659180 and 65918001, when...Becton, Dickinson and Company, BD BiosciencesOYE
Z-0072-2020Class IIBD FACSLyric Flow Cytometer, 3-Laser 8 Color Instrument, REF: 654587, when using BD...Becton, Dickinson and Company, BD BiosciencesOYE
Z-0071-2020Class IIBD FACSLyric Flow Cytometer, 2-Laser 6 Color Instrument, REF: 651165, when using BD...Becton, Dickinson and Company, BD BiosciencesOYE
Z-2760-2019Class IITRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 RIGHT Catalog # 5542-A-202 - Product...Howmedica Osteonics CorpMBH
Z-2759-2019Class IITRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 LEFTTriathlon Femoral Distal Augments are...Howmedica Osteonics CorpMBH
Z-2758-2019Class IITRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 RIGHT Catalog # 5541-A-202 - Product...Howmedica Osteonics CorpMBH
Z-2757-2019Class IITRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 LEFT Catalog # 5541-A-201 - Product Usage...Howmedica Osteonics CorpMBH
Z-0070-2020Class IIBD FACSLyric Flow Cytometer, 2-Laser 4 Color Instrument, REF: 651164, when using BD...Becton, Dickinson and Company, BD BiosciencesOYE
Z-0069-2020Class IIBD FACSLyric Flow Cytometer, 3-Laser 10 Color Instrument, REF: 662878, and 66287808 when...Becton, Dickinson and Company, BD BiosciencesOYE
Z-0068-2020Class IIBD FACSLyric Flow Cytometer, 3-Laser 8 Color Instrument, REF: 662877, when using BD...Becton, Dickinson and Company, BD BiosciencesOYE