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 339 of 1190
FDA device recalls, page 339 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2315-2020Class IIA.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE LEFT 11 HOLE 190MM, Item Number...Zimmer GmbHHRS
Z-2314-2020Class IIA.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 234MM Item...Zimmer GmbHHRS
Z-2313-2020Class IIA.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 140MM Item...Zimmer GmbHHRS
Z-2312-2020Class IIA.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 90MM, Item...Zimmer GmbHHRS
Z-2311-2020Class IIA.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM 3.2MM LOCKING PEG 60MM , Item Number: 110025460...Zimmer GmbHHRS
Z-2310-2020Class IIA.L.P.S. T15 Multi-Directional Locking Screw 3.5mm x 60mm, Item Number: 110017960...Zimmer GmbHHRS
Z-2309-2020Class IIA.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM 3.2MM CALIBRATED DRILL BIT, Item Number...Zimmer GmbHHRS
Z-2308-2020Class IIA.L.P.S. T15 LOW PROFILE CORTICAL SCREW 3.5mm x 28mm, Item Number: 110017628 - Product...Zimmer GmbHHRS
Z-2307-2020Class IIA.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM DRILL BLOCK GUIDE SLEEVE 2.7MM, Item Number...Zimmer GmbHHRS
Z-2306-2020Class IIA.L.P.S PROXIMAL HUMERUS PLATING SYSTEM DRILL BLOCK GUIDE SLEEVE 3.2MM, Item Number...Zimmer GmbHHRS
Z-2305-2020Class IIA.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM DRILL BLOCK SET SCREW, Item Number: 110017551...Zimmer GmbHHRS
Z-2304-2020Class IIBiomet 8.0 Cannulated Screw Tap-Bone fixation screw Item Number: 110008467 - Product...Zimmer GmbHHWC
Z-2303-2020Class IIBiomet 6.5 Cannulated Screw Tap - Bone fixation screw, Item Number: 110008466 - Product...Zimmer GmbHHWC
Z-2500-2020Class IIIrix-C Forceps Inserter; Product Code/UDI: T066-0059/ M697T06600591Xtant Medical Holdings, Inc.HWA
Z-2549-2020Class IIMOL3655 Simplexa VZV Swab Direct - Product Usage: is intended for use on the LIAISON MDX...DiaSorin Molecular LLCPGI
Z-2548-2020Class IIMOL3650 Simplexa VZV Direct - Product Usage: is intended for use on the LIAISON MDX...DiaSorin Molecular LLCPLO
Z-2547-2020Class IIMOL2150 Simplexa HSV 1&2 Direct -CSF -Genital Swab -Cutaneous / Mucocutaneous...DiaSorin Molecular LLCOQO
Z-2255-2020Class IIMultifire Endo Hernia 0 12mm Stapler with 4.0mm Disposable Loading Unit , Part No. 174027...Medtronic, Inc.GCI
Z-2254-2020Class IIMultifire Endo Hernia 0 12mm Stapler with 4.8mm Disposable Loading Unit , Part No. 174025...Medtronic, Inc.GCI
Z-2253-2020Class IIMultifire VersaTrack Auto Suture Hernia Stapler, 4.8mm, Part No. 174023 - Product Usage...Medtronic, Inc.GCI
Z-2252-2020Class IIMultifire VersaTrack Auto Suture Hernia Stapler, 4.0mm, Part No. 174021 - Product Usage...Medtronic, Inc.GCI
Z-2401-2020Class IIAlinity C, Processing Module. Chemistry analyzer for in-vitro diagnostics.Abbott MedicalJJE
Z-2243-2020Class IIType S Extension For use with Varian, CIVCO, Prescription Only - Product Usage: Device is...Medtec LLCIYE
Z-2039-2020Class IMedtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or...Medtronic IrelandDYB
Z-2367-2020Class IIVITROS Chemistry Product Performance Verifier II, Product Code 8067324, UDI #...Ortho-Clinical Diagnostics, Inc.CIW
Z-2366-2020Class IIVITROS Chemistry Product Performance Verifier I, Product Code 8231474, UDI #...Ortho-Clinical Diagnostics, Inc.CIW
Z-2300-2020Class IIComprehensive VRS Inserter, shoulder prosthesis, Item No. 110019068. UDI...Zimmer GmbHPHX
Z-2365-2020Class IIVITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/90 SLDS, Product Code...Ortho-Clinical Diagnostics, Inc.CIW
Z-2364-2020Class IIVITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/300 SLDS, Product Code...Ortho-Clinical Diagnostics, Inc.CIW
Z-2468-2020Class IIABL80-FLEX CO-OX 393-841 Box Label, REF 393-841, IVD, CE, UDI: 05700693938417 - Product...Radiometer Medical ApSCHL
Z-2467-2020Class IIABL80-FLEX-393-839 Box Label, REF 393-839, IVD, CE, UDI: 05700693938394 - Product Usage...Radiometer Medical ApSCHL
Z-2872-2020Class IIThe OEC 9900 C-Arm is designed to provide fluoroscopic and spot-film images of the...GE HealthcareRCC
Z-2472-2020Class IIuCT 530 Computed Tomography X-Ray SystemShanghai United Imaging Healthcare Co., Ltd.JAK
Z-2522-2020Class IIuCT 760 System, Computed Tomography X-ray SystemShanghai United Imaging Healthcare Co., Ltd.JAK
Z-2288-2020Class IIArrow FlexTip Plus Epidural Kit with NRFit Connector, catheter system, Product Codes...Arrow International LLC (subsidiary of Teleflex Incorporated)BSO
Z-2403-2020Class IIMerge Healthcare Merge Application Server Software Release and Merge Healthcare Merge...Merge Healthcare IncorporatedLLZ
Z-2388-2020Class IIMAMMOMAT Revelation, model no. 11343300 - Product Usage: is intended to be used for...Siemens Medical Solutions USA, Inc.MUE
Z-2405-2020Class IIAtellica Solution IM1600 Analyzer, Siemens Material Number 11066000, UDI # 00630414002026Siemens Healthcare Diagnostics Inc.JJE
Z-2404-2020Class IIAtellica Solution IM1300 Analyzer, Siemens Material Number 11066001, UDI # 00630414007960Siemens Healthcare Diagnostics Inc.JJE
Z-2387-2020Class IIStryker End Cap, Std, Ti Gamma3 Catalog Number: 30051100S - Product Usage: Stryker...Stryker Corp.HSB
Z-2386-2020Class IIStryker Locking Screw, Fully Threaded T2 Tibia 5x50 mm Catalog Number: 18965050S...Stryker Corp.HSB
Z-2385-2020Class IIStryker Locking Screw, Fully Threaded T2 Tibia 5x45 mm Catalog Number: 18965045S...Stryker Corp.HSB
Z-2384-2020Class IIStryker Locking Screw, Fully Threaded T2 Tibia 5x40 mm Catalog Number: 18965040S...Stryker Corp.HSB
Z-2383-2020Class IIStryker Locking Screw, Fully Threaded T2 Tibia 5x37,5 mm Catalog Number: 18965037S...Stryker Corp.HSB
Z-2382-2020Class IIStryker Locking Screw, Fully Threaded T2 Tibia 5x35 mm Catalog Number: 18965035S...Stryker Corp.HSB
Z-2381-2020Class IIStryker Locking Screw, Fully Threaded T2 Tibia 5x30 mm Catalog Number: 18965030S...Stryker Corp.HSB
Z-2380-2020Class IIStryker Locking Screw, Fully Threaded T2 Humerus 4x32 mm Catalog Number: 18964032S...Stryker Corp.HSB
Z-2379-2020Class IIStryker Locking Screw, Partially Threaded T2 Tibia 5x55 mm Catalog Number: 18915055S...Stryker Corp.HSB
Z-2378-2020Class IIStryker End Cap T2 Humerus 6mm, 15mm height Catalog Number: 18300015S - Product Usage...Stryker Corp.HSB
Z-2377-2020Class IIStryker 1 End Cap T2 Humerus 6mm, 5mm height Catalog Number: 18300005S - Product Usage...Stryker Corp.HSB