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 185 of 1190
FDA device recalls, page 185 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0002-2024Class IArrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF...Arrow International LLC (subsidiary of Teleflex Incorporated)FOZ
Z-0001-2024Class IArrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded...Arrow International LLC (subsidiary of Teleflex Incorporated)LJS
Z-0027-2024Class IIBard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016Bard Peripheral Vascular IncKNW
Z-2647-2023Class IIBaxter Epiphany Cardio Server E3 ECG Management System Servers with software versions...Baxter Healthcare CorporationDQK
Z-0169-2024Class IIMcGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx OnlyMedtronic, Inc.CCW
Z-0168-2024Class IIMcGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx OnlyMedtronic, Inc.CCW
Z-2664-2023Class IIVeran : Endobronchial Always on Track Models: INS-0392 AOTT 21ga Needle, 12mm L, 1.8mm...OLYMPUS Corporation of the AmericasJAK
Z-2663-2023Class IIVeran : Percutaneous Always on Track Models: INS-5040 Always-On vTrack Universal Tracker...OLYMPUS Corporation of the AmericasJAK
Z-2662-2023Class IIVeran : Endobronchial Models: INS-5500 View Optical Probe INS-5450 SPiN Xtend 21ga...OLYMPUS Corporation of the AmericasJAK
Z-2661-2023Class IIVeran : Percutaneous Models: INS-5620 SPiN Perc Biopsy Needle Guide Kit - 20cm, 5/Bx...OLYMPUS Corporation of the AmericasJAK
Z-2660-2023Class IIVeran Endobronchial: Models: INS-5925 SPiN Access Catheter 180 Degree for use w/ Pentax...OLYMPUS Corporation of the AmericasJAK
Z-2659-2023Class IIVeran:SPiN Thoracic Navigation System Models: SYS-4230 SPiN Thoracic Navigation System...OLYMPUS Corporation of the AmericasJAK
Z-2581-2023Class IIWelch Allyn Connex Spot MonitorBaxter Healthcare CorporationMWI
Z-2591-2023Class IIArrow ErgoPack, Pressure Injectable Two-Lumen PICC pre-loaded with Arrow VPS Stylet, REF...Arrow International LLC (subsidiary of Teleflex Incorporated)LJS
Z-2590-2023Class IIArrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; catheter...Arrow International LLC (subsidiary of Teleflex Incorporated)LJS
Z-2617-2023Class IIPDS II (polydioxanone) Suture, Product Numbers Z844G-50, D10065-05, D10085-05, D6776-05...Ethicon, IncNEW
Z-2616-2023Class IIPDS Plus Antibacterial (polydioxanone) Suture, Product Numbers PDP072H40, PDP259H50...Ethicon, IncNEW
Z-2626-2023Class IIFLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining...O&M Halyard, Inc.MSH
Z-0008-2024Class IIProboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System...Ortho-Clinical Diagnostics, Inc.JJE
Z-0843-2024Class IICentered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210Fx Shoulder Solutions Inc.PHX
Z-2666-2023Class IIADVIA Chemistry Iron_2 (IRON_2) Reagents, Material Numbers 10377510 (6 x 350 tests) and...Siemens Healthcare Diagnostics Inc.CDQ
Z-0007-2024Class I3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, 24 boxes per...Fresenius Medical Care Renal Therapies Group, LLCFMF
Z-0006-2024Class I10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per caseFresenius Medical Care Renal Therapies Group, LLCFMF
Z-0005-2024Class I10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a...Fresenius Medical Care Renal Therapies Group, LLCFMF
Z-2613-2023Class IIPrucka 3 Amplifiers, Model P1801PA, and Field Replaceable Units (FRUs), Model 5875569...GE Medical Systems Information Technologies, Inc.DQK
Z-2484-2023Class IIOculus Myopia Master , Ref 68100, CE 0123Oculus Optikgerate GmbHMXK
Z-2483-2023Class IIOculus Pentacam AXL , Ref 70100, CE 0123Oculus Optikgerate GmbHMXK
Z-2482-2023Class IIOculus Pentacam AXL Wave, Ref 70020, CE 0123Oculus Optikgerate GmbHMXK
Z-2450-2023Class IMallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack...Mallinckrodt Manufacturing LLCBZO
Z-2658-2023Class IIHeartmate 3 LVAS Implant Kit, REF: 106524US, 106524INT; Heartmate XVE & HeartMate II...Abbott MedicalDSQ
Z-2644-2023Class IIB.Braun NORM-JECT Luer Lock Solo, 10 ml, Sterile-Intended to be used to deliver (inject)...B Braun Medical IncFMF
Z-2643-2023Class IIB. Braun NORM-JECT Luer Solo, 10 ml, Sterile-Intended to be used to deliver (inject) or...B Braun Medical IncFMF
Z-2602-2023Class IIStryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozzle...Stryker Corp.LZN
Z-2601-2023Class IIStryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozzle...Stryker Corp.LZN
Z-2600-2023Class IIStryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle & Prox...Stryker Corp.LZN
Z-2599-2023Class IIStryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle & Solid...Stryker Corp.LZN
Z-2598-2023Class IIStryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle-Allows...Stryker Corp.LZN
Z-2597-2023Class IIStryker ACM (Advanced Cement Mixing): 180-Gram Cement Cartridge with Breakaway Femoral...Stryker Corp.LZN
Z-2596-2023Class IIStryker ACM (Advanced Cement Mixing) System: Break-Away Femoral Nozzle-, Allows the user...Stryker Corp.LZN
Z-2624-2023Class IIVITROS XT Chemistry Products ALKP SlidesOrtho-Clinical Diagnostics, Inc.CJE
Z-2623-2023Class IIVITROS XT Chemistry Products TBIL-ALKP SlidesOrtho-Clinical Diagnostics, Inc.CIG
Z-2607-2023Class IIDJO Surgical: Altivate Reverse, Humeral Stem, Small Shell, Size 6 x 108mm, REF: 533-06-108Encore Medical, LPKWS
Z-2606-2023Class IIDJO Surgical: Reverse Shoulder System (RSP) Semi Humeral Socket Insert, 32mm, REF...Encore Medical, LPPHX
Z-2605-2023Class IIDJO Surgical: CLP Hip, Stem, Polished Neck, Lateral Offset Implant, Size#3, REF...Encore Medical, LPKWA
Z-2604-2023Class IIDJO Surgical: Delta Ceramic Femoral Head, 44 mm + 4.0 mm, REF: 400-03-443Encore Medical, LPLZO
Z-2603-2023Class IIDJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106Encore Medical, LPJWH
Z-2514-2023Class IHUDSON RCI Addipak, UNIT DOSE VIALS, 5mL Sterile 0.9% NaCl Solution for Inhalation USP...MEDLINE INDUSTRIES, LP - NorthfieldCAF
Z-0097-2024Class IINOVAPLUS GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: V20685255 through V20685290Ansell Healthcare Products LLCKGO
Z-0096-2024Class IIGAMMEX NON-LATEX PI GREEN Surgical gloves, REF: 20685255 through 20685290Ansell Healthcare Products LLCKGO
Z-0120-2024Class IIMEDLINE ReNewal Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/ GEN11 SW v2018-1...MEDLINE INDUSTRIES, LP - NorthfieldNLQ