Medical Device
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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 822 of 1190
FDA device recalls, page 822 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1164-2013Class IIGE Healthcare, Xeleris 2 Processing & Review Workstation. The display, processing...GE HealthcareLLZ
Z-1643-2012BD Focal Point"230V LC (Refurbished), Catalog number: 490681. The BD Focal Point" Slide...Becton Dickinson & CoMKQ
Z-1642-2012BD Focal Point"230V / 15 FOV (Refurbished), Catalog number: 490138. The BD Focal Point"...Becton Dickinson & CoMKQ
Z-1641-2012BD Focal Point"230V / 15 FOV under 5%, Catalog number: 490137. The BD Focal Point" Slide...Becton Dickinson & CoMKQ
Z-1640-2012BD Focal Point"230V / 11 FOV (Refurbished), Catalog number: 490649. The BD Focal Point"...Becton Dickinson & CoMKQ
Z-1639-2012BD Focal Point"230V / 11 FOV under 5%, Catalog number: 490648. The BD Focal Point"...Becton Dickinson & CoMKQ
Z-1638-2012BD Focal Point"120V LC (Refurbished), Catalog number: 490683. The BD Focal Point" Slide...Becton Dickinson & CoMKQ
Z-1637-2012BD Focal Point"120V / 15 FOV (Refurbished), Catalog number: 490398. The BD Focal Point"...Becton Dickinson & CoMKQ
Z-1636-2012BD Focal Point"120v / 15 FOV under 5%, Catalog number: 490397. The BD Focal Point"...Becton Dickinson & CoMKQ
Z-1635-2012BD Focal Point"120V / 11 FOV (Refurbished), Catalog number: 490653. The BD Focal Point"...Becton Dickinson & CoMKQ
Z-1634-2012BD Focal Point"120V / 11 FOV under 5%, Catalog number: 490652 The BD Focal Point" Slide...Becton Dickinson & CoMKQ
Z-1633-2012BD Focal Point"100V LC (Refurbished), Catalog number: 490682 The BD Focal Point" Slide...Becton Dickinson & CoMKQ
Z-1632-2012BD Focal Point"100V / 15 FOV under 5%, Catalog number: (Refurbished) 490365 The BD Focal...Becton Dickinson & CoMKQ
Z-1631-2012BD Focal Point"100V / 15 FOV under 5%, Catalog number: 490364 The BD Focal Point" Slide...Becton Dickinson & CoMKQ
Z-1630-2012BD Focal Point"100V (Refurbished), Catalog number: 490651 The BD Focal Point" Slide...Becton Dickinson & CoMKQ
Z-1629-2012BD Focal Point"100V, Catalog number: 490650 The BD Focal Point" Slide Profiler (formerly...Becton Dickinson & CoMKQ
Z-0330-2012Varian brand GammaMed 12i Accessory: Clamping adapters for bronchial catheters, 1.8mm...Varian Medical Systems, Inc.JAQ
Z-0329-2012Varian brand GammaMed 12i Accessory: Clamping adapters for bronchial catheters, 1.8mm...Varian Medical Systems, Inc.JAQ
Z-1097-2012BD Oral Dispensing Syringe Oral Syringe Tip Caps various sizes ( 1 mL, 3 mL, 5 mL. 10 mL...Becton Dickinson & CoKYX
Z-0801-2012Nicolet C64 Stimulus Switching Unit (SSU Amplifier), Catalog/ Part Numbers: 382-610800...Medtronic, Inc.GYC
Z-0800-2012Nicolet Cortical Stimulator Control Unit, Catalog/Part Number: 982A0558 Product...Medtronic, Inc.GYC
Z-0799-2012NicoletOne Software v 5.60.2-5.71.4 with Cortical Stimulator License, Catalog/Part...Medtronic, Inc.GYC
Z-0273-2012IBC INTERNATIONAL BIOPHYSICS CORP. 2101-2 EAST ST. ELMO, SUITE 275, AUSTIN, TX 78744...International Biophysics Corp.DTS
Z-0704-2012Biomet Series A Asymmetrical Patella size 28mm, three pegs - 184791, Sterile, Biomet...Zimmer GmbHJWH
Z-0703-2012Biomet Series A Asymmetrical Patella size 25mm, three pegs - 184790, Sterile, Biomet...Zimmer GmbHJWH
Z-0702-2012Biomet Series A Thin Patella size 28mm, three pegs - 184782, Sterile, Biomet Orthopedics...Zimmer GmbHJWH
Z-0701-2012Biomet Series A Standard Patella size 28mm, three pegs - 184762, Sterile, Biomet...Zimmer GmbHJWH
Z-0700-2012Biomet Series A Standard Patella size 25mm, three pegs - 184760, Sterile, Biomet...Zimmer GmbHJWH
Z-0699-2012Biomet Series A Thin Patella size 25mm, one peg - 184720, Sterile, Biomet Orthopedics...Zimmer GmbHJWH
Z-0698-2012Biomet Series A Thin Patella size 25mm, one peg - 184720 Sterile, Biomet Orthopedics...Zimmer GmbHJWH
Z-0697-2012Biomet Series A Standard Patella size 28mm, one peg - 184702, Biomet Orthopedics, Warsaw...Zimmer GmbHJWH
Z-0696-2012Biomet Series A Standard Patella size 25mm, one peg, Part 184700, Sterile, Biomet...Zimmer GmbHJWH
Z-0695-2012Biomet Series A Thin Patella size 25mm, three pegs, Part 184780, Sterile, Biomet...Zimmer GmbHJWH
Z-0332-2012Head Ring Posts with part number 970.280 - re-usable components of the Frame Array Module...Varian Medical Systems, Inc.IYE
Z-0285-2012Curix Opthos H, size 35x43 cm A radiographic medical x-ray film designed to optimize...AGFA Healthcare Corp.IWZ
Z-0118-2012Philips Verardius Image Intensified X-ray Catalog Number: 718130 Product Usage...Philips North America LLCJAA
Z-0117-2012Philips BV Endura Fluoroscopic Image Intensified X-ray Catalog Number: 718074...Philips North America LLCJAA
Z-0116-2012Philips BV Pulsera Fluoroscopic Image Intensified X-ray Catalog Number...Philips North America LLCJAA
Z-0144-2012Bard Ventralex" ST Medium Circle with Strap Hernia Patch Diameter 6.4cm /2.5", Catalog...Davol Inc., Sub. C.R. Bard, Inc.FTL
Z-0070-2012LeMaitre 9F Pruitt F3 Outlying Carotid Shunt with T-port The Pruitt F3 Carotid Shunt...LeMaitre Vascular Inc.MJN
Z-0331-2012Model CAT-850B Catheterization Table, a component of the Toshiba INFX-8000 series X-Ray...Canon Medical Systems USA, Inc.MQB
Z-0189-2012Clinical Chemistry Urea Nitrogen List Number 7D75-21 and 7D75-31 used for the...Abbott MedicalCDQ
Z-0823-2013Class IIGE Healthcare, CARESCAPE Monitor B650. The CARESCAPE Monitor B650 is a multi-parameter...GE HealthcareMHX
Z-2331-2012Class IICMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Solution CMS-2981-R3...Custom Medical Specialties, Inc.LRP
Z-2330-2012Class IICMS-4219-R2 Custom Laser Pack containing 2 oz bottles PVP Prep Solution The PV contained...Custom Medical Specialties, Inc.LRP
Z-2329-2012Class IICMS-2890 Custom Needle Local Tray containing PVP Prep Pad The PV contained in the kit is...Custom Medical Specialties, Inc.LRP
Z-2328-2012Class IICMS-8412-R2 Custom Cysto Pack containing 2 oz. bottle of PVP Prep Solution The PV...Custom Medical Specialties, Inc.LRP
Z-2360-2012Class IBR980-9600 Hysteroscopy Sterile Procedure Kit containing 2 oz. bottle PVP Prep...Custom Medical Specialties, Inc.LRO
Z-2359-2012Class ICMS-5284 Custom Myelogram Tray containing 2 oz. bottle PVP Prep Solution Product Usage...Custom Medical Specialties, Inc.LRO
Z-2358-2012Class ICMS-4975 HSG Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The...Custom Medical Specialties, Inc.LRO