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-1019-04 | Monarc Subfascial Hammock With Tensioning Suture, Product Number 72403830/1 | American Medical Systems, Inc. | FTL | ||
| Z-0762-04 | VasoSeal ES, Extravascular Security Vascular Closure Device, Catalog No. 76000. Class... | Datascope Collagen Products Division | MGB | ||
| Z-1225-03 | Vitros Chemistry *** GLU (glucose) DT Slides ***25 slides per box *** CAT 153 2316 ***... | Ortho-Clinical Diagnostics, Inc. | CGA | ||
| Z-1224-03 | Vitros Chemistry *** GLU (glucose) Slides *** 5 cartridges each containing 60 slides for... | Ortho-Clinical Diagnostics, Inc. | CGA | ||
| Z-1207-03 | Angiotensin I [125I] Radioimmunoassay Kit, 500 Tube Catalog Number: NEA105 For in-vitro... | Revvity Health Sciences, Inc. | CIB | ||
| Z-1206-03 | Angiotensin I [125I] Radioimmunoassay Kit, 250 Tube Catalog Number: NEA104 For in-vitro... | Revvity Health Sciences, Inc. | CIB | ||
| Z-1244-03 | Disetronic Dahedi insulin infusion pump; catalog # 8500019. | Roche Diagnostics GmbH | LZG | ||
| Z-0080-04 | APSOF-7-4-RB, ZIMMON PANCREATIC STENT W/RADIOPAQUE BANDS, Stent Diameter: 7 FR., Length... | Wilson-Cook Medical Inc. | FGE | ||
| Z-1220-03 | Calculator/ Data Processing Module for Clinical Use | CliniSys, Inc | JQP | ||
| Z-1198-03 | Disetronic D-TRONplus Insulin Pump | Roche Diagnostics GmbH | LZG | ||
| Z-1240-03 | Calculator/ Data Processing Module for Clinical Use | CliniSys, Inc | JQP | ||
| Z-1221-03 | BD Blood Glucose Test strips. BD Latitude, 100 Test Strips 100 Bandelettes Reactives... | Becton Dickinson & Co | NBW | ||
| Z-1217-03 | Misys Laboratory System versions 5.2 through 5.3.2 using LabAccess Results | CliniSys, Inc | JQP | ||
| Z-1129-03 | IMx Rubella IgM Reagent Kit, 100 tests, list 7A24-20; Abbott Laboratories, Abbott Park... | Abbott Medical | LFX | ||
| Z-1091-03 | Frequency 55 Toric (methafilcon B), flexible wear contact lenses (tinted). Responsible... | CooperVision, Inc. | LPL | ||
| Z-0238-04 | Misys Laboratory System, versions 5.3 build 63 through 5.3.2 and LabAccess Results. | CliniSys, Inc | JQP | ||
| Z-1094-03 | Becton Dickinson's ProbeTec (tm) ET Instrument | Becton Dickinson & Co | LSL | ||
| Z-1140-03 | Anti-dsDNA [125I] Radiobinding Assay Kit. For In-Vitro Diagnostic Use Catalog Number... | Revvity Health Sciences, Inc. | DHN | ||
| Z-1141-03 | BiodivYsio SV Over The Wire (OTW) Coronary Stent, 2.25 mm diameter; Catalog #... | Abbott Vascular | MAF | ||
| Z-1078-03 | ''Alcon Ladarwave CustomCornea Wavefront System'' Aberrometer software Version 7.91 | Alcon Laboratories | |||
| Z-1197-03 | Disetronic H-TRONplus Insulin Pump; catalog # 8050023 [clear case], 8050064 [blue case]... | Roche Diagnostics GmbH | LZG | ||
| Z-1196-03 | Disetronic H-TRON V100 Insulin Pump; catalog # 8010030C [clear case] and 8010030... | Roche Diagnostics GmbH | LZG | ||
| Z-1202-03 | On-Site Alcohol IVD A single use enzymatic assay for qualitative detection of alcohol in... | Varian, Inc. | DML | ||
| Z-1143-03 | Femoral Resection Guide, Scorpio L.R.S. Instrumentation. | Howmedica Osteonics Corp | HTZ | ||
| Z-1242-03 | Diagnost 97 | Philips North America LLC | |||
| Z-0874-03 | OmniDiagnost System | Philips North America LLC | |||
| Z-1123-03 | Boston Scientific Scimed Monorail Express 2 Coronary Stent System, 3.5 mm x 32 mm... | Boston Scientific Corporation | MAF | ||
| Z-1122-03 | Radionics Cool-Tip RF Electrode Kit, containing DGP-HP single-use grounding pads. | Medtronic, Inc. | HAM | ||
| Z-1121-03 | Radionics Disposable Grounding Plate | Medtronic, Inc. | HAM | ||
| Z-1178-03 | Fenwal 3-Lead Blood/Solution Set with Large Standard Blood Filter, 15 drops/mL, 82'', 170... | Baxter Healthcare Corporation | BRZ | ||
| Z-1177-03 | Fenwal Y-Type Blood/Solution Set with Large Standard Blood Filter, 10 drops/mL, 82'', 170... | Baxter Healthcare Corporation | BRZ | ||
| Z-1176-03 | Fenwal Y-Type Blood/Solution Set with Large Standard Blood Filter, 15 drops/mL, 107'', 2... | Baxter Healthcare Corporation | BRZ | ||
| Z-1175-03 | Fenwal Straight Type Blood Set with Large Standard Blood filter, 15 drops/mL, 80'', 170... | Baxter Healthcare Corporation | BRZ | ||
| Z-1174-03 | Fenwal Y-Type Blood Component Recipient Set with Standard Blood Filter, 10 drops/mL... | Baxter Healthcare Corporation | KSB | ||
| Z-1173-03 | Fenwal Blood Component Recipient Set with Standard Blood Filter, 10 drops/mL, 55'', 170... | Baxter Healthcare Corporation | KSB | ||
| Z-1172-03 | Baxter Y-Type Blood/Solution Set with Pressure Pump, 10 drops/mL, 99'', Large Standard... | Baxter Healthcare Corporation | BRZ | ||
| Z-1171-03 | Baxter Y-Type Blood/Solution Set, 10 drops/mL, 115'', 80 Micron Filter, Injection Site... | Baxter Healthcare Corporation | BRZ | ||
| Z-1070-03 | Continu-Flo Solution Set, 10 drops/mL, 113'', 2 Luer Activated Valves, Male Luer Lock... | Baxter Healthcare Corporation | FPA | ||
| Z-1169-03 | Continu-Flo Solution Set, 10 drops/mL, 110'', 3 Luer Activated Valves, Male Luer Lock... | Baxter Healthcare Corporation | FPA | ||
| Z-1168-03 | Vented Solution Set, 10 drops/mL, 92'', Luer Activated Valve, Male Luer Lock Adapter... | Baxter Healthcare Corporation | FPA | ||
| Z-1167-03 | Baxter Solution Set, 60 drops/mL, 76'', Luer Activated Valve, Male Luer Lock Adapter... | Baxter Healthcare Corporation | FPA | ||
| Z-1166-03 | Baxter Solution Set, 10 drops/mL, 76'', Luer Activated Valve, Male Luer Lock Adapter... | Baxter Healthcare Corporation | FPA | ||
| Z-1165-03 | Baxter Y-Type Blood/Solution Set with Pressure Pump, 10 drops/mL, 99'', 170 to 260 Micron... | Baxter Healthcare Corporation | KSB | ||
| Z-1164-03 | Colleague Pump Syringe Adapter Set, 92'', Injection Site, Non-DEHP Tubing, Luer Lock... | Baxter Healthcare Corporation | FPA | ||
| Z-1163-03 | Fenwal Y-Type Blood/Solution Set with Large Standard Blood Filter, 15 drops/mL, 89'', 170... | Baxter Healthcare Corporation | BRZ | ||
| Z-1162-03 | Fenwal Y-Type Blood/Solution Set with Large Standard Blood Filter and Pressure Pump, 15... | Baxter Healthcare Corporation | KSB | ||
| Z-1161-03 | Clearlink System Y-Type Blood/Solution Set, 10 drops/mL, 112'', Standard Blood Filter... | Baxter Healthcare Corporation | KSB | ||
| Z-1160-03 | Baxter Y-Type Blood/Solution Set, 10 drops/mL, 112'', Standard Blood Filter, 170 to 260... | Baxter Healthcare Corporation | BRZ | ||
| Z-1159-03 | Continu-Flo Solution Set, 60 drops/mL, 106'', 3 Luer Activated Valves, Male Luer Lock... | Baxter Healthcare Corporation | FPA | ||
| Z-1158-03 | Clearlink System Vented Paclitaxel Set, 10 drops/mL, 111'', Polyethylene Lined Tubing... | Baxter Healthcare Corporation | FPA |