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-1157-03 | Clearlink System Nitroglycerin Set with DUO-VENT Spike, 60 drops/mL, 105'', PVC Tubing... | Baxter Healthcare Corporation | FPA | ||
| Z-1156-03 | Clearlink System Continu-Flo Solution Set, 10 drops/mL, 113'', 2 Luer Activated Valves... | Baxter Healthcare Corporation | FPA | ||
| Z-1155-03 | Baxter Vented Nitroglycerin Set, 105'', PVC Tubing Segment, Injeciton Site, Male Luer... | Baxter Healthcare Corporation | FPA | ||
| Z-1154-03 | Interlink System Vented Nitroglycerin Set, 104 '', PVC Tubing Segment, Injection Site... | Baxter Healthcare Corporation | FPA | ||
| Z-1153-03 | Continu-Flo Solution Set, 10 drops/mL, 104'', 0.22 Micron Downstream High Pressure... | Baxter Healthcare Corporation | FPA | ||
| Z-1152-03 | Interlink System Continu-Flo Solution Set with Microbore Tubing, 60 drops/mL, 128'', 3... | Baxter Healthcare Corporation | FPA | ||
| Z-1151-03 | Interlink System Solution Set with Microbore Tubing, 60 Drops/mL, 123'', 2 injection... | Baxter Healthcare Corporation | FPA | ||
| Z-1150-03 | Baxter Solution Set, 10 drops/mL, 101'', Male Luer Lock Adapter, catalog 1C8109; Baxter... | Baxter Healthcare Corporation | FPA | ||
| Z-1075-03 | Guidant Multi-Link Zeta Coronary Stent System | Abbott Vascular | |||
| Z-1124-03 | Intralase FS Laser System. Laser Keratome | Intralase Corp | GEX | ||
| Z-0937-03 | Datex-Ohmeda S/5 Anesthesia Delivery Units | GE Healthcare | BSZ | ||
| Z-0722-04 | Esprit Ventilator. | Respironics, Inc. | CBK | ||
| Z-1072-03 | IRMA SL Blood Analysis System CC pH, pCO2, pO2, Hct, Na+, K+, iCa Cartridge, Part Number... | Diametrics Medical, Inc. | JJE | ||
| Z-1137-03 | Barrier Hip Sheet with Side Pockets | Molnlycke Health Care | KKX | ||
| Z-0025-04 | Irrigation Aspiration System for Nezhat Dorsey Type Pumps with 33 cm Probe, and Tubing... | Vital Concepts, Inc. | GCY | ||
| Z-0024-04 | Quanta Technologies L.L.C. brand REORDER # LAPKIT 3. Contents 1 -55060... | Vital Concepts, Inc. | GCY | ||
| Z-0023-04 | HYDRO-PRO brand Suction-Irrigation System without Probe, Disposable (single use only)... | Vital Concepts, Inc. | GCY | ||
| Z-0022-04 | HYDRO-PRO brand Irrigation Aspiration System with double Spike Tubing, no Probe... | Vital Concepts, Inc. | GCY | ||
| Z-0021-04 | Irrigation Aspiration System with Double Spike Tubing and 33 cm Probe, Disposable (single... | Vital Concepts, Inc. | GCY | ||
| Z-0020-04 | Huntington Instruments brand Irrigation Aspiration System with Single Spike Tubing and 33... | Vital Concepts, Inc. | GCY | ||
| Z-1086-03 | Prosorba Protein A Immunoadsorption Column | Fresenius Hemocare GmbH | LQQ | ||
| Z-1235-03 | CaverMap Surgical Aid Disposable Kit with Focused Probe Tip, Sterile Part Number: 8305 | Blue Torch Medical Technologies | |||
| Z-1038-03 | CryoValve, Synegraft Pulmonary Valve & Conduit | Artivion, Inc. | MIE | ||
| Z-1068-03 | Ventra Percutaneous Intravenous Catheter Repair Kit for 11 French Triple-Lumen External... | Abbott Medical | FOZ | ||
| Z-1067-03 | Ventra Percutaneous Intravenous Catheter Repair Kit for 9 French Dual-Lumen External... | Abbott Medical | FOZ | ||
| Z-1066-03 | Ventra Percutaneous Intravenous Catheter Repair Kit for Luer Connector Segments and... | Abbott Medical | FOZ | ||
| Z-1035-03 | 9 French Super Arrow-Flex Percutaneous Sheath Introducer Kit with Arrowg and Blue... | Arrow International LLC (subsidiary of Teleflex Incorporated) | |||
| Z-0151-04 | Misys Laboratory System, Versions 5.2, 5.23, 5.3 up to 5.3.2. | CliniSys, Inc | JQP | ||
| Z-1063-03 | ASAP Channel Cut Biopsy System, 18 gauge Reference Number: 1394 | Boston Scientific Corporation | |||
| Z-1062-03 | ASAP Channel Cut Biopsy System, 15 gauge Reference Number: 1390 | Boston Scientific Corporation | |||
| Z-1061-03 | ASAP Channel Cut Biopsy System, 14 gauge Reference Number: 1250 | Boston Scientific Corporation | KNW | ||
| Z-1018-03 | MSI-EpiDermGlu (Iso-Butyl 2 Cyanoacrylate) tissue adhesive for soft tissue approximation... | Elite Medical Group | MPN-- | ||
| Z-0840-03 | MagicView 1000 and Magic View Mondo. Digital Image Communication. | Siemens Medical Solutions USA, Inc. | LMD | ||
| Z-1092-03 | Misys Laboratory System version 5.3 | CliniSys, Inc | JQP | ||
| Z-1036-03 | AMO PhacoFlex II Model SI40NB, Intraocular Lenses | Advanced Medical Optics, Inc. | |||
| Z-1120-03 | Ultra-soft SV Monorail Balloon Dilatation Catheters, 7.0 mm/2.0 cm/90 cm, Reference... | Boston Scientific Corporation | GBR | ||
| Z-1119-03 | Ultra-soft SV Monorail Balloon Dilatation Catheters, 6.0 mm/2.0 cm/90 cm, Reference... | Boston Scientific Corporation | GBR | ||
| Z-1118-03 | Ultra-soft SV Monorail Balloon Dilatation Catheters, 5.0 mm/2.0 cm/90 cm, Reference... | Boston Scientific Corporation | GBR | ||
| Z-1117-03 | Ultra-soft SV Monorail Balloon Dilatation Catheters, 5.0 mm/1.5 cm/90 cm, Reference... | Boston Scientific Corporation | GBR | ||
| Z-1116-03 | Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0 mm/2.0 cm/90 cm, Reference... | Boston Scientific Corporation | GBR | ||
| Z-1115-03 | Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0 mm/1.5 cm/90 cm, Reference... | Boston Scientific Corporation | GBR | ||
| Z-1114-03 | Ultra-soft SV Monorail Balloon Dilatation Catheters, 6.0 mm/2.0 cm/150 cm, Reference... | Boston Scientific Corporation | GBR | ||
| Z-1113-03 | Ultra-soft SV Monorail Balloon Dilatation Catheters, 5.0 mm/2.0 cm/150 cm, Reference... | Boston Scientific Corporation | GBR | ||
| Z-1112-03 | Ultra-soft SV Monorail Balloon Dilatation Catheters, 7.0 mm/ 2.0 cm/150 cm, Reference... | Boston Scientific Corporation | GBR | ||
| Z-1111-03 | Ultra-soft SV Monorail Balloon Dilatation Catheters, 6.5 mm/ 1.5 cm/150 cm, Reference... | Boston Scientific Corporation | GBR | ||
| Z-1110-03 | Ultra-soft SV Monorail Balloon Dilatation Catheters, 6.0 mm/ 1.5 cm/150 cm, Reference... | Boston Scientific Corporation | GBR | ||
| Z-1109-03 | Ultra-soft SV Monorail Balloon Dilatation Catheters, 5.5 mm/ 2.0 cm/150 cm, Reference... | Boston Scientific Corporation | GBR | ||
| Z-1108-03 | Ultra-soft SV Monorail Balloon Dilatation Catheters, 5.0 mm/ 1.5 cm/150 cm, Reference... | Boston Scientific Corporation | GBR | ||
| Z-1107-03 | Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.5 mm/ 2.0 cm/150 cm, Reference... | Boston Scientific Corporation | GBR | ||
| Z-1106-03 | Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.5 mm/ 1.5 cm/150 cm, Reference... | Boston Scientific Corporation | GBR |