Medical Device
Manufacturing
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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 831 of 1190
FDA device recalls, page 831 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2927-2011Stryker Medical Stretcher Model 1105 Prime 5th Wheel A wheeled stretcher consists of a...Stryker MedicalINK
Z-2865-2011Prime 5th Wheel Stryker Medical Stretchers Model 1105 Intended to transport patients in...Stryker MedicalFPO
Z-2864-2011Eye Surgery Stryker Medical Stretchers Model 1089 Intended to transport patients in a...Stryker MedicalFPO
Z-2863-2011Trauma Stryker Medical Stretchers Model 1037 Intended to transport patients in a...Stryker MedicalFPO
Z-2862-2011Transport Stryker Medical Stretchers Model 748 Intended to transport patients in a...Stryker MedicalFPO
Z-2926-20111125 Prime Zoom Stryker Medical Stretcher A wheeled stretcher consists of a platform...Stryker MedicalINK
Z-2925-2011Stryker Medical Stretcher Model 1115 Prime Big Wheel A wheeled stretcher consists of a...Stryker MedicalINK
Z-2924-2011Stryker Medical Stretcher Model 1089 Eye Surgery A wheeled stretcher consists of a...Stryker MedicalINK
Z-2923-2011Stryker Medical Stretcher Model 1037 Trauma A wheeled stretcher consists of a platform...Stryker MedicalINK
Z-2922-2011Stryker Medical Stretcher Model 748 Transport A wheeled stretcher consists of a platform...Stryker MedicalINK
Z-2921-2011Stryker Medical Stretcher Model 747 Transport A wheeled stretcher consists of a platform...Stryker MedicalINK
Z-2861-2011Sechrist Stryker Medical Stretchers Model 742 Intended to transport patients in a...Stryker MedicalFPO
Z-3086-2011Microline Surgical ReNew Laproscopic ControlTip Atraumatic Fenestrated Grasper Forceps...Microline Surgical, IncGEI
Z-3085-2011Microline Surgical ReNew Laproscopic Long Fenestrated Grasper Forceps Tip Ref: 3262 The...Microline Surgical, IncGEI
Z-0057-2012MicroMaxx ultrasound system and M-Turbo ultrasound system is Medical Diagnostic...FUJIFILM SonoSite,Inc.IYN
Z-2952-2011Spectranetics Turbo-Booster Laser Guide Catheter, 8 Fr, REF 518-063, Sterile EO...Spectranetics Corp.DQY
Z-2951-2011Spectranetics Turbo-Booster Laser Guide Catheter, 7 Fr, REF 518-043, Sterile EO...Spectranetics Corp.DQY
Z-2892-2011Aquamantys 2.3 Bipolar Sealer Model #23-113-1. Product Usage: The Aquamantys Bipolar...Salient Surgical Technologies, Inc.
Z-2975-2011STAR S4 IR Excimer Laser System; Software Version 5.30 Mfg by : AMO Manufacturing USA...Advanced Medical Optics, Inc.LZS
Z-2974-2011STAR S4 IR Excimer Laser System; Software Version 5.22 Mfg by : AMO Manufacturing USA...Advanced Medical Optics, Inc.LZS
Z-2973-2011STAR S4 IR Excimer Laser System; Software Version 5.21 Mfg by : AMO Manufacturing USA...Advanced Medical Optics, Inc.LZS
Z-2972-2011STAR S4 IR Excimer Laser System; Software Version 5.20 Mfg by : AMO Manufacturing USA...Advanced Medical Optics, Inc.LZS
Z-2971-2011STAR S4 IR Excimer Laser System; Software Version 5.18 Mfg by : AMO Manufacturing USA...Advanced Medical Optics, Inc.LZS
Z-2970-2011STAR S4 IR Excimer Laser System; Software Version 5.16 Mfg by : AMO Manufacturing USA...Advanced Medical Optics, Inc.LZS
Z-2969-2011STAR S4 IR Excimer Laser System; Software Version 5.15 Mfg by : AMO Manufacturing USA...Advanced Medical Optics, Inc.LZS
Z-2968-2011STAR S4 IR Excimer Laser System; Software Version 5.10 Mfg by : AMO Manufacturing USA...Advanced Medical Optics, Inc.LZS
Z-2967-2011STAR S4 IR Excimer Laser System; Software Version 5.02 Mfg by : AMO Manufacturing USA...Advanced Medical Optics, Inc.LZS
Z-2966-2011STAR S4 IR Excimer Laser System; Software Version 5.01 Mfg by : AMO Manufacturing USA...Advanced Medical Optics, Inc.LZS
Z-2965-2011STAR S4 IR Excimer Laser System; Software Version 5.00 Mfg by : AMO Manufacturing USA...Advanced Medical Optics, Inc.LZS
Z-1214-2012D-SPECT Cardiac Scanner System -- COMMON/USUAL NAME: Emission Computed Tomography System...Spectrum Dynamics, Ltd.KPS
Z-0034-2012Axle Interspinous Fusion System Torque Driver Handle, Model #: X060-0323, Lot # 525941...Xtant Medical Holdings, Inc.FZS
Z-3186-2011Medtronic FlexCath, model 3FC12, Steerable Sheath. The FlexCath Steerable Sheath is a...Medtronic, Inc.DRA
Z-3049-2011Churchill Medical Latex-Free IV Start Kit Product Code: AMS-623ATLF The kit includes a...Vygon MfgLRS
Z-3026-2011AlterG Anti-Gravity Treadmill; Alter G, 48349 Milmont Drive, Fremont, Ca 94538 Product...AlterG, IncorporatedBXB
Z-2857-2011Global Focus Marketing and Distribution, Silencer S2200 CentrifugeGlobal Focus Marketing & DevelopJQC
Z-0075-2012Total Hip Joint Replacement Accolade TMZF Plus 127 Neck Angle V40 Hip Stem #3 Accolade...Howmedica Osteonics CorpMEH
Z-0776-2012Spacelabs Medical Ultraview SL Command Module, Model 91496. The Spacelabs...GE HealthcareDSI
Z-0209-2012SoftPath GUI versions: 3.17.5 to 3.17.9, 4.2.1 to 4.2.3, and 4.3.0 to 4.3.0.4. SoftPath...SCC Soft ComputerJQP
Z-0178-2012LifeCell Strattice Reconstructive Tissue Matrix for Stoma Reinforcement Catalog #0606008...LifeCell CorpFTM
Z-3108-2011HiArt versions 4.0.x, and HD versions 1.0.x, H-0000-0003. The TomoTherapy HI-ART System...Accuray IncorporatedMUJ
Z-3000-2011Titanium Fletcher-style Applicator Set - Defined Geometry - CT Compatible with Titanium...Varian Medical Systems, Inc.JAQ
Z-2999-2011Titanium Fletcher-style Applicator Set - Defined Geometry - CT Compatible with Titanium...Varian Medical Systems, Inc.JAQ
Z-2998-2011Titanium Fletcher-style Applicator Set - Defined Geometry - CT Compatible with Titanium...Varian Medical Systems, Inc.JAQ
Z-2997-2011Titanium Fletcher-style Applicator Set - Defined Geometry - CT Compatible with Titanium...Varian Medical Systems, Inc.JAQ
Z-2996-2011Titanium Fletcher-style Applicator Set - Defined Geometry - CT Compatible with Titanium...Varian Medical Systems, Inc.JAQ
Z-2995-2011Titanium Fletcher-style Applicator Set - Defined Geometry - CT Compatible with Titanium...Varian Medical Systems, Inc.JAQ
Z-3055-2011Flexible Probe with Blocking Washer (part of Segmented Cylinder Set) The Segmented...Varian Medical Systems, Inc.JAQ
Z-2993-2011GammaMed Plastic Needle with Mandrin; 2.0mm diameter, length 320 mm. Remote controlled...Varian Medical Systems, Inc.JAQ
Z-2992-2011GammaMed Plastic Needle with Mandrin; 2.0mm diameter, length 200 mm. Remote controlled...Varian Medical Systems, Inc.JAQ
Z-2991-2011GammaMed Plastic Needle with Mandrin; 2.0mm diameter, length 113 mm. Remote controlled...Varian Medical Systems, Inc.JAQ