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-1767-2010 | DURAMAX (TM) Hemodialysis Catheters, Stacked Tip 55 cm Straight Basic Kit, Catalog... | Boston Scientific Corporation | MSD | ||
| Z-1766-2010 | DURAMAX (TM) Hemodialysis Catheters, Stacked Tip 40 cm Straight Basic Kit, Catalog... | Boston Scientific Corporation | MSD | ||
| Z-1765-2010 | DURAMAX (TM) Hemodialysis Catheters, Stacked Tip 36 cm Straight Basic Kit, Catalog... | Boston Scientific Corporation | MSD | ||
| Z-1764-2010 | DURAMAX (TM) Hemodialysis Catheters, Stacked Tip 32 cm Straight Basic Kit, Catalog... | Boston Scientific Corporation | MSD | ||
| Z-1763-2010 | DURAMAX (TM) Hemodialysis Catheters, Stacked Tip 28 cm Straight Basic Kit, Catalog... | Boston Scientific Corporation | MSD | ||
| Z-1762-2010 | DURAMAX (TM) Hemodialysis Catheters, Stacked Tip 24 cm Straight Basic Kit, Catalog... | Boston Scientific Corporation | MSD | ||
| Z-1761-2010 | DURAMAX (TM) Hemodialysis Catheters, Stacked Tip 22 cm Straight Basic Kit, Catalog... | Boston Scientific Corporation | MSD | ||
| Z-1138-2010 | Modified Novy Cornual Cannulation Set with clear tip, G17478, REF J-NCS-503570, Cook... | Cook Women'S Health | MOV | ||
| Z-0857-2010 | Cardinal Health EnVe Ventilator Cat # 19250-001, Manufactured by Cardinal Health... | Pulmonetic Systems, Inc. | CBK | ||
| Z-0797-2010 | MICRON BOBBIN VENT TUBE, 1.27 MM I.D., TITANIUM, REF 145281-ENT, QTY 1, STERILE EO... | Gyrus ACMI, Inc. | ETD | ||
| Z-0800-2010 | HomeChoice PRO Automated Peritoneal Dialysis Systems; Catalog Numbers; 5C8310, 5C8310R... | Baxter Healthcare Renal Div | FKX | ||
| Z-0799-2010 | Baxter HomeChoice Automated Peritoneal Dialysis Systems; Catalog Numbers: 5C4471... | Baxter Healthcare Renal Div | FKX | ||
| Z-1137-2010 | Modified Novy Cornual Cannulation Set with clear tip, G17558, REF J-NCS-504070, Cook... | Cook Women'S Health | MOV | ||
| Z-1730-2010 | Bausch & Lomb MicroFlow 2.2 30 Phaco Needle, Model DP8730S, 6 pouches/box. The firm... | Bausch & Lomb Incorporated | HQC | ||
| Z-1729-2010 | Bausch & Lomb Thin Tip 30 angled Phaco Needle, Model DP8430AS, 6 pouches/box. The firm... | Bausch & Lomb Incorporated | HQC | ||
| Z-1728-2010 | Bausch & Lomb Thin Tip 30 Phaco Needle, Model DP8430S, 6 pouches/box. The firm name on... | Bausch & Lomb Incorporated | HQC | ||
| Z-1727-2010 | Bausch & Lomb MicroFlow Plus 30 Phaco Needle, Model DP8330S, 6 pouches/box. The firm... | Bausch & Lomb Incorporated | HQC | ||
| Z-1726-2010 | Bausch & Lomb MicroFlow 45 Phaco Needle, Model DP8245S, 6 pouches/box. The firm name on... | Bausch & Lomb Incorporated | HQC | ||
| Z-1725-2010 | Bausch & Lomb MicroFlow 30 Phaco Needle, Model DP8230S, 6 pouches/box. The firm name on... | Bausch & Lomb Incorporated | HQC | ||
| Z-1724-2010 | Bausch & Lomb 19G Standard 45 Phaco Needle, Model DP8145S, 6 pouches per box. The firm... | Bausch & Lomb Incorporated | HQC | ||
| Z-1723-2010 | Bausch & Lomb 19G Standard 30 Phaco Needle, Model DP8130S, 6 pouches/box. The firm name... | Bausch & Lomb Incorporated | HQC | ||
| Z-1722-2010 | Bausch & Lomb Stellaris 1.8mm Micro Incision AFS Phaco Pack with MICS Angled Needle... | Bausch & Lomb Incorporated | HQE | ||
| Z-1721-2010 | Bausch & Lomb Stellaris 1.8mm Micro Incision AFS Phaco Pack with MICS Needle, Model... | Bausch & Lomb Incorporated | HQE | ||
| Z-1720-2010 | Bausch & Lomb Stellaris 1.8mm Premium Vacuum Phaco Pack with MICS Angled Needle, Model... | Bausch & Lomb Incorporated | HQE | ||
| Z-1719-2010 | Bausch & Lomb Stellaris 1.8mm Premium Vacuum Phaco Pack with MICS Needle, Model BL5114, 6... | Bausch & Lomb Incorporated | HQE | ||
| Z-1718-2010 | Bausch & Lomb Stellaris 1.8mm StableChamber Phaco Pack with MICS Angled Needle, Model... | Bausch & Lomb Incorporated | HQE | ||
| Z-1717-2010 | Bausch & Lomb Stellaris 1.8mm StableChamber Phaco Pack with MICS Needle, Model BL5113, 6... | Bausch & Lomb Incorporated | HQE | ||
| Z-1716-2010 | Bausch & Lomb Stellaris Basic AFS Phaco Pack, Model BL5121, 6 packs/box, RX, Sterile... | Bausch & Lomb Incorporated | HQE | ||
| Z-1715-2010 | Bausch & Lomb Stellaris Premium AFS Phaco Pack, Model BL5120, 6 packs/box, RX, Sterile... | Bausch & Lomb Incorporated | HQE | ||
| Z-1714-2010 | Bausch & Lomb Stellaris Optimized Stability Vacuum Pack, Model BL5112, 6 packs/box, RX... | Bausch & Lomb Incorporated | HQE | ||
| Z-1713-2010 | Bausch & Lomb Stellaris Vacuum Phaco Pack, Model BL5111, 6 packs/box, RX, Sterile. The... | Bausch & Lomb Incorporated | HQE | ||
| Z-1712-2010 | Bausch & Lomb Stellaris Premium Vacuum Phaco Pack, Model BL5110, 6 packs/box, RX... | Bausch & Lomb Incorporated | HQE | ||
| Z-1711-2010 | Bausch & Lomb Millennium Micro Incision Premium Venturi Pack, Model CX4320, 6 packs/box... | Bausch & Lomb Incorporated | HQC | ||
| Z-1710-2010 | Bausch & Lomb Millennium Advanced Flow System Phaco Pack, Model CX5310, 6 packs/box, RX... | Bausch & Lomb Incorporated | HQF | ||
| Z-1709-2010 | Bausch & Lomb Millennium Premium Venturi Phaco Pack, Model DP4310 and DP4310E, 6... | Bausch & Lomb Incorporated | HQC | ||
| Z-1708-2010 | Bausch & Lomb Millennium Basic Venturi Phaco Pack, Models DP4305 and DP4305E, 12... | Bausch & Lomb Incorporated | HQC | ||
| Z-0809-2010 | LifeShield Latex-free Primary I.V. Set, convertible P.P. yellow key slide clamp... | Abbott Medical | FPA | ||
| Z-0808-2010 | LifeShield Latex-Free Primary SYMBIQ Set, Piggyback with Backcheck Valve, 3 Prepierced... | Abbott Medical | FPA | ||
| Z-1131-2010 | Optovue RTVue Optical Coherence Tomography (OCT), Model-RT100 with software versions... | Optovue Inc. | OBO | ||
| Z-2639-2010 | One Touch Ultra Test Strips, Part Number 020-245-32, lot number 2964512, Manufactured by... | Lifescan, Inc. | NBW | ||
| Z-0907-2010 | Aquilion One Whole Body X-Ray CT Scanner Whole body computed tomography scanning | Canon Medical Systems USA, Inc. | JAK | ||
| Z-2203-2011 | Software for SSH-880CV Aplio Artida; System Diagnostic Ultrasound | Canon Medical Systems USA, Inc. | IYN | ||
| Z-1199-2010 | Avanta Fluid Management Injection System, Avanta Multi-Patient Disposable Set (MPAT) High... | Medrad, Inc. | DXT | ||
| Z-0825-2010 | Synthes In Situ Bender/Cutter Kit-Wide-Sterile. Catalog Number 530.521S. | Synthes GmbH | HRS | ||
| Z-0894-2010 | Mistique Infusion Catheter, K12-MIC04505, Sterile EO, Merit Medical Systems, Inc., South... | Merit Medical Systems, Inc. | KRA | ||
| Z-0893-2010 | Mistique Infusion Catheter, K12-MIC04510, Sterile EO, Merit Medical Systems, Inc., South... | Merit Medical Systems, Inc. | KRA | ||
| Z-0892-2010 | Mistique Infusion Catheter, K12-MIC09005, Sterile EO, Merit Medical Systems, Inc., South... | Merit Medical Systems, Inc. | KRA | ||
| Z-0891-2010 | Mistique Infusion Catheter, K12-MIC09010, Sterile EO, Merit Medical Systems, Inc., South... | Merit Medical Systems, Inc. | KRA | ||
| Z-0890-2010 | Mistique Infusion Catheter, K12-MIC13505, Sterile EO, Merit Medical Systems, Inc., South... | Merit Medical Systems, Inc. | KRA | ||
| Z-0889-2010 | Mistique Infusion Catheter, K12-MIC13510, Sterile EO, Merit Medical Systems, Inc., South... | Merit Medical Systems, Inc. | KRA |