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-2245-2008 | Cannon Catheter" II, Long-Term Access. Catheter Length, Cuff to Tip: 31cm, CS-15362... | Arrow International LLC (subsidiary of Teleflex Incorporated) | MSD | ||
| Z-2244-2008 | Cannon Catheter" II, Long-Term Access. Catheter Length, Cuff to Tip: 27cm, CS-15322... | Arrow International LLC (subsidiary of Teleflex Incorporated) | MSD | ||
| Z-2243-2008 | Cannon Catheter" II, Long-Term Access. Catheter Length, Cuff to Tip: 23cm, CS-15282... | Arrow International LLC (subsidiary of Teleflex Incorporated) | MSD | ||
| Z-2242-2008 | Cannon Catheter" II, Long-Term Access. Catheter Length, Cuff to Tip: 19cm, CS-15242... | Arrow International LLC (subsidiary of Teleflex Incorporated) | MSD | ||
| Z-2310-2008 | AMO WaveScan WaveFront System Version 3.90/3.901, Part Number 0070-1478. The device is... | Visx Incorporated, a Subsidiary of AMO Inc | LZS | ||
| Z-2179-2008 | Zimmer 4.5 Compression plate-broad, 10 hole, 167 MM length, stainless steel, non sterile... | Zimmer GmbH | HRS | ||
| Z-2406-2008 | ACIST" BRACCO, AT P54 AngioTouch Kit , SKU # 014644, Sterile EO Manufacturer; ACTB... | Acist Medical Systems, Inc. | DXT | ||
| Z-2141-2008 | Boston Scientific NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System... | Boston Scientific Corporation | NIM | ||
| Z-2230-2008 | Siemens brand Ultrasound Transducer 17L5HD used with ACUSON Sequoia Ultrasound... | Siemens Medical Solutions USA, Inc. | IYO | ||
| Z-1060-2009 | PROSTIVA RF Model 8929 Hand Piece is the delivery system component of the PROSTIVA RF... | Medtronic Neuromodulation | KNS | ||
| Z-2389-2008 | NicoletOne photic adapter cable 085-463700 | Medtronic, Inc. | GWQ | ||
| Z-2313-2008 | The St. Jude Medical Livewire TC" Ablation Catheter, 8mm Tip w/Thermocouple & Thermistor... | Abbott Medical | LPB | ||
| Z-2294-2008 | Stryker Ortholock, Stryker, Kalamazoo, MI; Part 6007-003-000. Stryker Ortholock is used... | Stryker Corp. | HAW | ||
| Z-2293-2008 | Stryker Ortholock EX Pin for use with the Stryker Navigation System, 4 mm x 150 mm... | Stryker Corp. | HAW | ||
| Z-2292-2008 | Stryker Ortholock EX Pin for use with the Stryker Navigation System, 3 mm x 110 mm... | Stryker Corp. | HAW | ||
| Z-2291-2008 | Stryker Navigation Pin for use with the Stryker Navigation System, 4 mm x 150 mm... | Stryker Corp. | HAW | ||
| Z-2290-2008 | Stryker Navigation Pin for use with the Stryker Navigation System, 4 mm x 100 mm... | Stryker Corp. | HAW | ||
| Z-2289-2008 | Stryker Navigation Pin for use with the Stryker Navigation System, 3 mm x 150 mm... | Stryker Corp. | HAW | ||
| Z-2288-2008 | Stryker Navigation Pin for use with the Stryker Navigation System, 3 mm x 100 mm... | Stryker Corp. | HAW | ||
| Z-2238-2008 | Reflex Revision Screwdriver Inner Shaft is a orthopedic manual surgical instrument that... | Howmedica Osteonics Corp | HXX | ||
| Z-2167-2008 | Radiation Protective Eyewear (only involving multifocals. FTC 28 Progress X-Ray... | Phillips Safety Products, Inc. | HOY | ||
| Z-0483-2009 | RNAgents Total RNA Isolation System (Cat. # Z5110). Kit Box label/Box drawer label... | Promega Corporation | LTD | ||
| Z-2212-2008 | Acuson CV70 Ultrasound systems Ultrasonic Pulsed echo/doppler imaging system with... | Siemens Medical Solutions USA, Inc. | IYN | ||
| Z-2180-2008 | Impax 6.x Clients including: 6.3 all versions below 6.3.1 SU5, 6.2 all versions below... | AGFA Healthcare Corp. | LLZ | ||
| Z-2227-2017 | Class II | Sesamoid Plasty, Stereotaxic Instrument The Sesamoid Plasty workstation is used to run... | Zimmer CAS | HAW | |
| Z-1371-2012 | The EM 2400 is a Pharmacy Compounding System consisting of three sub-systems for... | Baxter Corporation Englewood | NEP | ||
| Z-1003-2009 | GE Healthcare Infinia Hawkeye 4, Model Numbers: 5178728, ASM500060, H3000WC and... | GE Healthcare | KPS | ||
| Z-1002-2009 | GE Healthcare Infinia Hawkeye, Model Numbers: H3000WR, H3000WW, H3000WZ, H3000YM and... | GE Healthcare | KPS | ||
| Z-1001-2009 | GE Healthcare Infinia, Model Numbers: ASM000886, ASM001391, ASM001333, ASM001465... | GE Healthcare | KPS | ||
| Z-1121-2009 | GE Healthcare, Infinia Hawkeye 4, Model Numbers: 5178728, ASM500060, H3000WC and... | GE Healthcare | KPS | ||
| Z-1120-2009 | GE Healthcare, Hawkeye for Infinia, Model Numbers: H3000WR , H3000WW, H3000WZ , H3000YM... | GE Healthcare | KPS | ||
| Z-1119-2009 | GE Healthcare, Infinia, Model Numbers: ASM000886 ASM001391 ASM001333 ASM001465... | GE Healthcare | KPS | ||
| Z-0164-2009 | Varian RV Software Varian Treatment for Non-Varian Linacs Version 6.6.5042 and... | Varian Medical Systems, Inc. | IYE | ||
| Z-2303-2008 | Histochemical PAS (Periodic Acid Schiff) Reaction Set' Class I, IVD; Set of 4 bottles... | EMD Millipore Corporation | HZT | ||
| Z-2175-2008 | AxSYM Rubella IgG Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; list 3B23-20... | Abbott Medical | LFX | ||
| Z-2204-2008 | da Vinci S Surgical System, Model number IS2000 Endoscopic Instrument Control System... | Intuitive Surgical, Inc. | NAY | ||
| Z-1900-2008 | PainSmart, PainSmart IOD Ambulatory Infusion System, Model Number: 360-1301 | Curlin Medical LLC | FRN | ||
| Z-1899-2008 | Model 6000 CMS, CMS IOD, or Plus Ambulatory Infusion Pump, Model Number: 360-1101 | Curlin Medical LLC | FRN | ||
| Z-1898-2008 | Model 4000 CMS Ambulatory Infusion Pump, Model Number: 350-1101 | Curlin Medical LLC | FRN | ||
| Z-1897-2008 | Model 4000 Plus Ambulatory Infusion Pump, Model Number: 350-1001 | Curlin Medical LLC | FRN | ||
| Z-1896-2008 | Model 2000 CMS/ Model 2000 Plus Ambulatory Infusion Pump, Model Number: 340-1001 | Curlin Medical LLC | FRN | ||
| Z-2156-2008 | Medtronic Midas Rex Legend tapered dissecting tool, Model F2/8TA23 Medtronic Powered... | Medtronic Powered Surgical Solutions | HBB | ||
| Z-1132-2010 | PTS Panels LDL Cholesterol test strips for professional use with CardioChek P-A test... | Polymer Technology Systems | MRR | ||
| Z-0851-2010 | GEN*S SlideMaker, Barcode Label Specifications, GEN*S SM Intended Use, GEN*S Slide and... | Siemens Healthcare Diagnostics Inc. | KPA | ||
| Z-0850-2010 | COULTER LH SlideMaker, LH Barcode Specification, LH SM Intended Use, LH Slide and Sample... | Siemens Healthcare Diagnostics Inc. | KPA | ||
| Z-2228-2008 | Metal Hemiarthroplasty, MDL E536687, Part # 03-6000-1, 03-6000-02, 03-600-03, 03-6000-04... | Orthopro, LLC | KWD | ||
| Z-2195-2008 | Varian Medical Systems FastPlan, versions 5.5 and 5.5.1, model number HZ3, manufactured... | Varian Medical Systems, Inc. | IYE | ||
| Z-2015-2008 | Biopsy Guide Starter Kits L9-5 used with the Philips HD3 Ultrasound System intended for... | Philips North America LLC | IYN | ||
| Z-2014-2008 | Biopsy Guide Starter Kits C7-3 used with the Philips HD3 Ultrasound System intended for... | Philips North America LLC | IYN | ||
| Z-2013-2008 | Biopsy Guide Starter Kits C5-2 used with the Philips HD3 Ultrasound System intended for... | Philips North America LLC | IYN |