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
| Recall number | Class | Product | Recalling firm | Product code | Initiated |
|---|---|---|---|---|---|
| Z-3287-2011 | PHILIPS NM3 Monitor Model Number: 7900 PHILIPS NM3 Monitor, English Part Number... | Respironics Novametrix, LLC. | BZK | ||
| Z-3121-2011 | GE Healthcare, 1.5T Optima MR450w Product Usage: The Optima MR450w is a whole body... | GE Healthcare | LNH | ||
| Z-0081-2012 | Medpro AccuFlo Elastomeric Infusion Device, Model #CT-0020-270C, packaged 12/box. The... | Progressive Medical Inc | MEB | ||
| Z-1614-2012 | Coseal Surgical Sealant. Coseal is an adjunctive surgical sealant. | Baxter Healthcare Corporation | NBE | ||
| Z-3159-2011 | VARIANT II TURBO Link Hemoglobin A1c Program Reorder Pack. Calibrator/Diluent... | Bio-Rad Laboratories Inc. | LCP | ||
| Z-0613-2013 | Class II | Access Immunoassay Systems Total T4 Calibrators, Part Number: 33805. The Access Total... | Siemens Healthcare Diagnostics Inc. | JIS | |
| Z-3090-2011 | Bausch & Lomb Stellaris 1.8mm Premium Vacuum Phaco Pack with MICS Needle, Ref: BL5114... | Bausch & Lomb Incorporated | HQC | ||
| Z-3089-2011 | Bausch & Lomb Stellaris Optimized Stability Vacuum Pack, Ref: BL5112, packaged 6... | Bausch & Lomb Incorporated | HQC | ||
| Z-3088-2011 | Bausch & Lomb Stellaris Basic Vacuum Phaco Pack, Ref: BL5111, packaged 6 units/case... | Bausch & Lomb Incorporated | HQC | ||
| Z-3087-2011 | Bausch & Lomb Stellaris Premium Vacuum Phaco Pack, Ref: BL5110, packaged 6 units/case... | Bausch & Lomb Incorporated | HQC | ||
| Z-3174-2011 | Coloplast Corp.-MN 06093, Country of origin: DK ( SenSura 19011 Post-Op, ostomy bag... | MEDLINE INDUSTRIES, LP - Northfield | EXB | ||
| Z-3205-2011 | PCR Eleva Radiological Image Processing System with software R.1.2 Philips Healthcare... | Philips North America LLC | LLZ | ||
| Z-3172-2011 | Wound Dressing Kit - Tier I, 10 MM Flat Drain; product code 0877061. Medela Healthcare... | Medela AG | MCY | ||
| Z-2956-2011 | Haemonetics cardioPAT -Cardiovascular Perioperative Autotransfusion System Model 2050... | Haemonetics Corporation | CAC | ||
| Z-0519-2012 | Smith & Nephew, SPIDER2 Limb Positioner, including accessories Battery, foot pedal and... | Smith & Nephew, Inc. | FQO | ||
| Z-0444-2012 | SoftLab used with SA INST 4.0.2.0 to 4.0.2.51, 4.0.3.0 to 4.0.3.13, 4.5.0.0 to 4.5.0.9... | SCC Soft Computer | JQP | ||
| Z-3182-2011 | Leica Bond Ready-to-Use Primary Antibody Epithelial Membrane Antigen (GP1.4); an in vitro... | Leica Microsystems, Inc. | NJT | ||
| Z-3181-2011 | Leica Bond Ready-to-Use Primary Antibody CDX2 (AMT28); an in vitro diagnostic... | Leica Microsystems, Inc. | NJT | ||
| Z-3180-2011 | Leica Bond Aspirating Probe Cleaning System; an in vitro diagnostic immunohistochemistry... | Leica Microsystems, Inc. | NJT | ||
| Z-1188-2013 | Class II | GE, VCT for Discovery VCT, Discovery RX VCT, and Discovery PET/CT 690, Lightspeed VCT... | GE Healthcare | JAK | |
| Z-3179-2011 | Olympus Fluid Aspiration Set; a sterile set of silicone tubing and connectors for use... | Northgate Technologies Inc. | KQT | ||
| Z-2958-2011 | Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Baxter... | Baxter Healthcare Corporation | FRN | ||
| Z-3007-2011 | Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pump. Baxter... | Baxter Healthcare Corporation | FRN | ||
| Z-3008-2011 | Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Baxter... | Baxter Healthcare Corporation | FRN | ||
| Z-1186-2013 | Class II | SL3 SOFT-TISSUE Laser (Model LR2002); Manuf: Discus Dental, LLC, 8550 Higuera Street... | Discus Dental LLC | GEX | |
| Z-3194-2011 | 4D Integrated Treatment Console v 8.6 with ARIA RT Chart v8.5, all of 4DITC v 8.3; Varian... | Varian Medical Systems, Inc. | IYE | ||
| Z-3062-2011 | TruChoice Alliant Healthcare Products, REFERENCE# SSD-100EX, QUANTITY: 25, DESCRIPTION... | Surge Medical Sales, LLC (dba Surge Cardiovascular) | MJJ | ||
| Z-3061-2011 | Non-Adjustable Vent Valve, TruChoice Alliant Healthcare Products, REFERENCE#213-035... | Surge Medical Sales, LLC (dba Surge Cardiovascular) | MJJ | ||
| Z-3060-2011 | Non-Adjustable Vent Valve, TruChoice Alliant Healthcare Products, REFERENCE#213-035NS... | Surge Medical Sales, LLC (dba Surge Cardiovascular) | MJJ | ||
| Z-3059-2011 | Adjustable Vent Valve, TruChoice Alliant Healthcare Products REFERENCE#213-030NS... | Surge Medical Sales, LLC (dba Surge Cardiovascular) | MJJ | ||
| Z-3058-2011 | Adjustable Vent Valve, TruChoice Alliant Healthcare Products REFERENCE#213-030 QUANTITY... | Surge Medical Sales, LLC (dba Surge Cardiovascular) | MJJ | ||
| Z-2950-2011 | CAPIOX Flexible Venous Reservoirs, 1500 mL, product codes: CXFVR1500X and CXFVRI500XC... | Terumo Cardiovascular Systems Corporation | DTN | ||
| Z-2920-2011 | Baxter Solution Set with Duo-Vent Spike; 109" (2.8 m), Male Luer Lock Adapter 10... | Baxter Healthcare Corporation | FPA | ||
| Z-3015-2011 | Fluoroscan Mini C-arm, Models: FSIII, FSIIIC and Officemate The Officemate, FSIII and... | Hologic, Inc. | JAA | ||
| Z-3078-2011 | MagNA Pure LC 2.0 (software version 1.1.23 and 1.1.24) Roche Diagnostics Operations... | Roche Diagnostics GmbH | LXG | ||
| Z-3077-2011 | MagNA Pure LC 1.0 (software version 3.0.11). Roche Diagnostics Operations, Inc. An... | Roche Diagnostics GmbH | LXG | ||
| Z-3109-2011 | REF 91200, Juggerknot system, Soft Anchors, -Two implants size 1, Biomet Sports Medicine... | Zimmer GmbH | MBI | ||
| Z-2201-2013 | Class II | GE Healthcare, CARESCAPE Monitor B850. Intended for use in multiple areas within a... | GE Healthcare | MHX | |
| Z-0654-2012 | MANI Needle and Suture Pack, 5-0 PGA Absorbable, Model 3391, 45 cm suture and needle... | Mani, Inc. (Head Office) | GAM | ||
| Z-0653-2012 | MANI Needle and Suture Pack, 6-0 PGA Absorbable, Model 2890, 45 cm suture and needle... | Mani, Inc. (Head Office) | GAM | ||
| Z-0652-2012 | MANI Needle and Suture Pack, 6-0 PGA Absorbable, Model 2490, 45 cm suture and needle... | Mani, Inc. (Head Office) | GAM | ||
| Z-0651-2012 | MANI Needle and Suture Pack, 7-0 PGA Absorbable, Model 2092, 45 cm suture and needle... | Mani, Inc. (Head Office) | GAM | ||
| Z-0650-2012 | MANI Needle and Suture Pack, 7-0 PGA Absorbable, Model 2091, 30 cm suture and needle... | Mani, Inc. (Head Office) | GAM | ||
| Z-0363-2012 | SoftPath GUI versions: 4.2.3.3-4.2.3.6 and 4.3.0.5-4.3.0.12. SoftPath is a laboratory... | SCC Soft Computer | JQP | ||
| Z-0649-2012 | MANI Needle and Suture Pack, 8-0 PGA Absorbable, Model 2090, 30 cm suture and needle... | Mani, Inc. (Head Office) | GAM | ||
| Z-3119-2011 | Operations and Technical Manuals for the firm's WarmAir Model 135 Hyperthermia System... | Gentherm Medical, LLC | DWJ | ||
| Z-3105-2011 | Varian Treatment version 6.6.5052. Varian Medical Systems, Palo Alto, Ca Intended to... | Varian Medical Systems, Inc. | IYE | ||
| Z-3056-2011 | The Resolution II Clip, 155 cm size and 235 cm size, Boxes of 1, 10, and 20 clips... | Boston Scientific Corporation | FHN | ||
| Z-3014-2011 | Metha(R) Hip System Cobalt Chrome (CoCr) Metha Modular Neck Adapters used with the Metha... | Aesculap Inc | LZO | ||
| Z-3039-2011 | Dimension Calcium Flex Reagent is used on the Dimension clinical chemistry system as an... | Siemens Healthcare Diagnostics Inc. | JJE |