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-0866-2010 | EXXCEL Soft Standard Wall EPTFE Vascular Graft; D:8 mm: L: 50 mm straight Maquet... | Maquet Cardiovascular LLC | DSY | ||
| Z-0892-2011 | Varian brand C-Series Ximatron Radiotherapy Treatment Stimulator, Model H72, Product is... | Varian Medical Systems, Inc. | |||
| Z-1681-2010 | InSound Medical, Inc, Lyric in-canal hearing aid. | Insound Medical, Inc. | ESD | ||
| Z-1135-2010 | Philips Switched Internal Defibrillator Paddles (used with Philips HeartStart XL and... | Philips North America LLC | MKJ | ||
| Z-2442-2010 | Closed Tube Aliquotter (CTA) for UniCel DxC 600i, Part Number: A25637, Domestic; A25633... | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-2441-2010 | Unicel Synchron Clinical Systems Closed Tube Aliquotter (CTA) for Synchron LXi 725, Part... | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-1139-2010 | remel A.C.T. II Sterile Pack Tube, Collection and Transport System, Ref 12402, 10/pk... | Remel Inc | JSM | ||
| Z-0792-2010 | Stryker Xia Precision System; Jam Shidi 13 Gauge 5 inch; Sterile; Manufactured for... | Howmedica Osteonics Corp | LHX | ||
| Z-0791-2010 | Stryker Xia Precision System; Jam Shidi 11 Gauge 5 inch; Sterile; Manufactured for... | Howmedica Osteonics Corp | LXH | ||
| Z-0790-2010 | Stryker Xia Precision System; Jam Shidi 10 Gauge 5 inch; Sterile; Manufactured for... | Howmedica Osteonics Corp | LXH | ||
| Z-0789-2010 | Stryker Xia Precision System; Jam Shidi 10 Gauge 9 inch; Sterile; Manufactured for... | Howmedica Osteonics Corp | LXH | ||
| Z-1319-2010 | BIOMET MICROFIXATION, PATIENT DISTRACTOR DRIVER 10.87cm, (4.28")(L), RADEL, STAINLESS... | Biomet Microfixation | HWR | ||
| Z-1023-2011 | Radiation therapy device. Medical charged particle radiation therapy system with software... | Accuray Incorporated | MUJ | ||
| Z-0920-2010 | 8400 Capnocheck Capnometer uses power cord 8404 (Electri-Cord Manufacturing, 312 E. Main... | Abbott Medical | CCK | ||
| Z-0919-2010 | BCI 3180 Pulse Oximeter uses power cord WW3005 (Electri-Cord Manufacturing Co., 312 E... | Abbott Medical | DQA | ||
| Z-0918-2010 | 9200 Advisor Vital Signs Monitor uses power cord WW3005 (Electri-Cord Manufacturing Co... | Abbott Medical | CCK | ||
| Z-1111-2010 | Wampole Staph Latex Test, 6.0 ml -120 Test Kit For In Vitro Diagnostic Use Catalog... | NERL Diagnostics Corporation | JWX | ||
| Z-1664-2010 | Bausch & Lomb Stellaris Vision Enhancement System. | Bausch & Lomb Incorporated | NFJ | ||
| Z-1663-2010 | Bausch & Lomb Millennium Microsurgical System. | Bausch & Lomb Incorporated | NFJ | ||
| Z-1110-2010 | Lifesign Staph Latex Kits, 6 ml For In Vitro Diagnostic Use Catalog Number... | NERL Diagnostics Corporation | JWX | ||
| Z-0878-2013 | Class II | Versafitcup Impacting Ring Model Number: 01.26.10.0133 (46mm), 01.26.10.0134 (48mm)... | Medacta USA, Inc. | MEH | |
| Z-1950-2010 | Coseal Surgical Sealant 8mL, Product Codes: 934072 & 934075. Indicated for use in... | Baxter Healthcare Corporation | NBE | ||
| Z-1949-2010 | Coseal Surgical Sealant 4mL, Product Codes: 934071 & 934074. Indicated for use in... | Baxter Healthcare Corporation | NBE | ||
| Z-1948-2010 | Coseal Surgical Sealant 2mL, Product Codes: 934070 & 934073. Indicated for use in... | Baxter Healthcare Corporation | NBE | ||
| Z-1242-2010 | PROMOS Inclination set, SIZE 26mm, REF 42 186, S&N 75006725, QTY: (1), STERILE R, Smith &... | Smith & Nephew, Inc. | KWS | ||
| Z-1241-2010 | PROMOS Inclination set, SIZE 24mm, REF 42 184, S&N 75006724, QTY: (1), STERILE R, Smith &... | Smith & Nephew, Inc. | KWS | ||
| Z-1240-2010 | PROMOS Inclination set, SIZE 22mm, REF 42 182, S&N 75006723, QTY: (1), STERILE R, Smith &... | Smith & Nephew, Inc. | KWS | ||
| Z-1239-2010 | PROMOS Inclination set, SIZE 20mm, REF 42 180, S&N 75006722, QTY: (1), STERILE R, Smith &... | Smith & Nephew, Inc. | KWS | ||
| Z-1192-2010 | AOS Trochanteric Nail, 12mm x 20cm x 135, Product Part Number: 1043-200. | Advanced Orthopaedic Solutions, Inc. | HSB | ||
| Z-1191-2010 | AOS Trochanteric Nail, 10mm x 20cm x 135, Product Part Number: 1042-200. | Advanced Orthopaedic Solutions, Inc. | HSB | ||
| Z-1190-2010 | AOS Trochanteric Nail, 12mm x 20cm x 130, Product Part Number: 1041-200. | Advanced Orthopaedic Solutions, Inc. | HSB | ||
| Z-1189-2010 | AOS Trochanteric Nail, 12mm x 17cm x 130, Product Part Number: 1041-170. | Advanced Orthopaedic Solutions, Inc. | HSB | ||
| Z-1188-2010 | AOS Trochanteric Nail, 10mm x 20cm x 130, Product Part Number: 1040-200. | Advanced Orthopaedic Solutions, Inc. | HSB | ||
| Z-1187-2010 | AOS Trochanteric Nail, 10mm x 17cm x 130, Product Part Number: 1040-170 | Advanced Orthopaedic Solutions, Inc. | HSB | ||
| Z-1186-2010 | AOS Trochanteric Nail, 11mm x 20cm x 135, Product Part Number: 1038-200. | Advanced Orthopaedic Solutions, Inc. | HSB | ||
| Z-118-2010 | AOS Trochanteric Nail, 13mm x 20cm x 130, Product Part Number: 1037-200. | Advanced Orthopaedic Solutions, Inc. | HSB | ||
| Z-1184-2010 | AOS Trochanteric Nail, 11mm x 20cm x 130, Product Part Number: 1036-200. | Advanced Orthopaedic Solutions, Inc. | HSB | ||
| Z-1183-2010 | AOS Trochanteric Nail, 11mm x 17cm x 130, Product Part Number: 1036-170. | Advanced Orthopaedic Solutions, Inc. | HSB | ||
| Z-1182-2010 | AOS Trochanteric Nail, 9mm x 20cm x 130, Product Part Number: 1034-200. | Advanced Orthopaedic Solutions, Inc. | HSB | ||
| Z-1181-2010 | AOS Trochanteric Nail, 9mm x 17cm x 130, Product Part Number: 1034-170. | Advanced Orthopaedic Solutions, Inc. | HSB | ||
| Z-0862-2010 | Huber Plus Non-Coring Needle Safety Infusion Set, 19g, 1 inch, REF 011901, Sterile EO... | Bard Access Systems, Inc. | FPA | ||
| Z-0861-2010 | Huber Plus Non-Coring Needle Safety Infusion Set, 19g, 1 inch, Needless Y-site, REF... | Bard Access Systems, Inc. | FPA | ||
| Z-1103-2010 | NIPRO, GLUCOPRO INSULIN SYRINGES, SINGLE USE INSULIN SYRINGE with needle, 1CC 30g 5/16"... | Nipro Medical Corporation | FMF | ||
| Z-1081-2010 | Suturable DuraGen Dural Regeneration Matrix; Non-Pyrogenic; Sterility guaranteed unless... | Integra LifeSciences Corporation | GXQ | ||
| Z-1040-2010 | Teleflex Medical, Hudson RCI, Concha Therm Neptune, Heated Humidifier. Product numbers... | Teleflex Medical | BTT | ||
| Z-0798-2010 | 2-Channel Laryngeal Surface Electrode (Model LSE500DCS and LSE500DCL) For use as a... | Neurovision Medical Products Inc | ETN | ||
| Z-1771-2010 | DURAMAX (TM) Hemodialysis Catheters, Stack Tip 36 cm Pre-Curve Basic Kit, Catalog... | Boston Scientific Corporation | MSD | ||
| Z-1770-2010 | DURAMAX (TM) Hemodialysis Catheters, Stack Tip 32 cm Pre-Curve Basic Kit, Catalog... | Boston Scientific Corporation | MSD | ||
| Z-1769-2010 | DURAMAX (TM) Hemodialysis Catheters, Stack Tip 28 cm Pre-Curve Basic Kit, Catalog... | Boston Scientific Corporation | MSD | ||
| Z-1768-2010 | DURAMAX (TM) Hemodialysis Catheters, Stack Tip 24 cm Pre-Curve Basic Kit, Catalog... | Boston Scientific Corporation | MSD |