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-0840-2009 | Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/20 cm, sterile, Cook... | Cook Incorporated | FAD | ||
| Z-0541-2009 | MicroScan Synergies Plus Negative Panels, 20 panels per box Medical device designed for... | Siemens Healthcare Diagnostics Inc. | JWY | ||
| Z-0540-2009 | MicroScan Synergies Plus Dried Overnight Gram Negative MIC/Combo Panels, 20 panels per... | Siemens Healthcare Diagnostics Inc. | LON | ||
| Z-2340-2008 | FloSeal Endoscopic Applicator , Product Code 1500181. The product is indicated in... | Baxter Healthcare Corporation | LMF | ||
| Z-0839-2009 | Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/18 cm, sterile, Cook... | Cook Incorporated | FAD | ||
| Z-1033-2009 | InteliFUSE, Drill Bit, 2.00 mm, J-Latch, QTY: 1, REF: DB.200.JL, non-sterile, 1515... | Intelifuse, Inc. | HTW | ||
| Z-1032-2009 | InteliFUSE, Drill Bit, 1.50 mm, J-Latch, QTY: 1, REF: DB.150.JL, non-sterile, 1515... | Intelifuse, Inc. | HTW | ||
| Z-0215-2009 | VACUETTE, 2 ml Lithium Heparin Venous Blood Collection Tubes. Reference #454237, 13x75... | Greiner Bio-One North America, Inc. | JKA | ||
| Z-2440-2008 | 500 mL InfoV.A.C. Canister (without Gel); Part #M8275071/5 (5 canister pack) and Part... | KCI USA, Inc. | JCX | ||
| Z-2439-2008 | 500 mL InfoV.A.C. Canisters (with Gel); Part #M8275063/5 (5 canister pack) and Part... | KCI USA, Inc. | JCX | ||
| Z-2430-2008 | Kallestad (TM) Mouse Kidney. Product labeled "BIO-RAD Kallestad (TM) Mouse Kidney... | Bio-Rad Laboratories Inc. | DBL | ||
| Z-2429-2008 | Kallestad (TM) Mouse Stomach/Kidney, catalog number 30443 - 8 wells, 48 tests. Product... | Bio-Rad Laboratories Inc. | DHN | ||
| Z-2428-2008 | Kallestad (TM) HEp-2 Cell Line Substrate. Product labeled "BIO-RAD Kallestad (TM) HEp-2... | Bio-Rad Laboratories Inc. | DBM | ||
| Z-0838-2009 | NeuroTherm Simplicity III RF Electrode Model Number: RFDE-SI The lesioning of neural... | Neurotherm, Inc. | GXI | ||
| Z-0181-2009 | Biomet brand Modular Microplasty Cup Inserter, 3/8" thread, Biomet Orthopedics, Inc... | Zimmer GmbH | LXH | ||
| Z-0667-2009 | Maximo II CRT D284TRK, for ventricular pacing and defibrillation. | Medtronic, Inc. | NIK | ||
| Z-0666-2009 | Medtronic Maximo II VR D284VRC, for ventricular pacing and defibrillation. | Medtronic, Inc. | LWS | ||
| Z-0665-2009 | Medtronic Maximo II DR D28DRG, for ventricular pacing and defibrillation. | Medtronic, Inc. | LWS | ||
| Z-0286-2009 | Posey Synthetic Leather and Biothane Waist and Wrist Restraints, Catalog Numbers: 2217SL... | J. T. Posey Co. | FMQ | ||
| Z-2438-2008 | Innova 4100 / 4100 IQ , GE Healthcare, Waukesha, WI 53188 (The system consists of an a... | GE Healthcare | MQB | ||
| Z-2437-2008 | Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188... | GE Healthcare | MQB | ||
| Z-2436-2008 | Innova 2100IQ (The Digital Fluoroscopic Imaging System consists of an a monoplane... | GE Healthcare | MQB | ||
| Z-2435-2008 | Innova 2000; The principle system components include a C-arm, image acquisition... | GE Healthcare | MQB | ||
| Z-0959-2009 | S-Series Short Range Headpiece Model Number MMT-5300-00 (beige) and MMT-5300-10 (brown)... | Advanced Bionics LLC | MCM | ||
| Z-0958-2009 | S-Series Long Range Headpiece Model Number AB-5301-00 (beige) and AB-5301-10 (brown)... | Advanced Bionics LLC | MCM | ||
| Z-0957-2009 | Platinum Series Headpiece Model Number AB-7300. The headpiece is used in conjunction... | Advanced Bionics LLC | MCM | ||
| Z-0956-2009 | HR90K Platinum Series Headpiece Model Number AB-7300-001 ADVANCED BIONICS LLC 12740 San... | Advanced Bionics LLC | MCM | ||
| Z-0150-2009 | LIFEPAK Express Automated External Defibrillator (AED). Labeling on the device states... | Physio Control, Inc. | MKJ | ||
| Z-0149-2009 | LIFEPAK CR Plus Automated External Defibrillator (AED). Labeling on the device states... | Physio Control, Inc. | MKJ | ||
| Z-1576-2009 | Inovel N95 HealthCare Particulate Respirator, Model/Catalog Number: FRN95-SEZ, Expiration... | Moldex/Metric, Inc. | MSH | ||
| Z-0545-2009 | Siemens syngo Dynamics Workplace, version 6.0, Siemens Medical Solutions, Ann Arbor, MI... | Siemens Medical Solutions USA, Inc. | LLZ | ||
| Z-0544-2009 | Siemens syngo Dynamics Workplace, version 5.0, Siemens Medical Solutions, Ann Arbor, MI... | Siemens Medical Solutions USA, Inc. | LLZ | ||
| Z-0543-2009 | Siemens KinetDx 4.2 Workplace, Siemens Medical Solutions, Ann Arbor, MI... | Siemens Medical Solutions USA, Inc. | LLZ | ||
| Z-2395-2008 | Power Drive. Battery-driven power tool system intended for use during surgical... | Synthes GmbH | GEY | ||
| Z-2426-2008 | Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 66/60, code Z, Zimmer... | Zimmer GmbH | KWA | ||
| Z-2425-2008 | Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 64/58, code X, Zimmer... | Zimmer GmbH | KWA | ||
| Z-2424-2008 | Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 62/56, code V, Zimmer... | Zimmer GmbH | KWA | ||
| Z-2423-2008 | Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 60/54, code T, Zimmer... | Zimmer GmbH | KWA | ||
| Z-2422-2008 | Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 58/52, code R, Zimmer... | Zimmer GmbH | KWA | ||
| Z-2421-2008 | Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 56/50, code P, Zimmer... | Zimmer GmbH | KWA | ||
| Z-2420-2008 | Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 54/48, code N, Zimmer... | Zimmer GmbH | KWA | ||
| Z-2419-2008 | Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 52/46, code L, Zimmer... | Zimmer GmbH | KWA | ||
| Z-2418-2008 | Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 50/44, code J, Zimmer... | Zimmer GmbH | KWA | ||
| Z-2417-2008 | Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 48/42, code H, Zimmer... | Zimmer GmbH | KWA | ||
| Z-2416-2008 | Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 46/40, code F, Zimmer... | Zimmer GmbH | KWA | ||
| Z-2415-2008 | Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 44/38, code D, Zimmer... | Zimmer GmbH | KWA | ||
| Z-2369-2008 | Philips Telemonitoring System Software (M3811B) used with Philips Telemonitoring System... | Philips North America LLC | DQA | ||
| Z-2343-2008 | Ultraview SL Command Module, Model 91496 The product is intended for use with the Patient... | GE Healthcare | DSI | ||
| Z-2342-2008 | Ultraview SL Command Module, Model 90496 The product is intended for use with the Patient... | GE Healthcare | DSI | ||
| Z-0226-2009 | BD GeneOhm MRSA 48 ct, Catalog #441244. IDI-MRSA assay is a qualitative in vitro... | BD Diagnostics (Geneohm Sciences, Inc.) | NQX |