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-0463-2007 | Depuy Preservation Uni-Compartmental Knee Fixed Tibial Tray, cemented, Right Medial/Left... | Depuy Orthopaedics Inc. | HRY | ||
| Z-0462-2007 | Depuy Preservation Uni-Compartmental Knee Fixed Tibial Tray, cemented, Left Medial/Right... | Depuy Orthopaedics Inc. | HRY | ||
| Z-0461-2007 | Depuy Preservation Uni-Compartmental Knee Fixed Tibial Tray, cemented, Right Medial/Left... | Depuy Orthopaedics Inc. | HRY | ||
| Z-0460-2007 | Depuy Preservation Uni-Compartmental Knee Fixed Tibial Tray, cemented, Left Medial/Right... | Depuy Orthopaedics Inc. | HRY | ||
| Z-0459-2007 | Depuy Preservation Uni-Compartmental Knee Fixed Tibial Tray, cemented, Right Medial/Left... | Depuy Orthopaedics Inc. | HRY | ||
| Z-0458-2007 | Depuy Preservation Uni-Compartmental Knee Fixed Tibial Tray, cemented, Left Medial/Right... | Depuy Orthopaedics Inc. | HRY | ||
| Z-0457-2007 | Depuy Preservation Uni-Compartmental Knee Fixed Tibial Tray, cemented, Right Medial/Left... | Depuy Orthopaedics Inc. | HRY | ||
| Z-0456-2007 | Depuy Preservation Uni-Compartmental Knee Fixed Tibial Tray, cemented, Left Medial/Right... | Depuy Orthopaedics Inc. | HRY | ||
| Z-0343-2007 | Welch Allyn PIC 50 Portable Intensive Care System, Multi-Parameter Monitor/Defibrillator... | MRL, Inc., A Welch Allyn Company | MJK | ||
| Z-0596-2007 | JariTrak Table Clamp, 1 inch diameter, vertical post, Catalog Number 206-160. The... | J. Jamner Surgical Instruments, Inc. | KDC | ||
| Z-2339-2008 | Sunrise Medical Quickie Groove Power Wheelchair with Transit option The product is a... | Sunrise Medical, Inc. | ITI | ||
| Z-0361-2008 | VKS PE Tibia Insert Ultra-Congruent; Left, Size 2, 12mm; Model Number: 0214612; Plus... | Plus Orthopedics | JWH | ||
| Z-1095-2007 | ABL 800 FLEX series blood gas analyzers containing software version 5.24. | Radiometer America, Inc | CHL | ||
| Z-1094-2007 | ABL 700 Series blood gas analyzers equipped with Software Version 3.833. | Radiometer America, Inc | CHL | ||
| Z-0482-2007 | BHM Reacher for Portable Ceiling Lifts; a portable ceiling lift accessory used to connect... | Arjo, Inc. | FSA | ||
| Z-0240-2008 | Hill-Rom VersaCare Hospital Bed System; Models P3200 and P3201, Hill-Rom, Batesville, IN... | Hill-Rom Inc. | FIN | ||
| Z-0593-2007 | POOLE Suction Instrument, REF 0035040. MANUFACTURED FOR CONMED CORPORATION, 310 Broad... | ConMed Corporation | GCJ | ||
| Z-0592-2007 | FRAZIER Olive Tip Suction Instrument, 10 Fr. with Control Vent and Obturator (Bend with... | ConMed Corporation | GCJ | ||
| Z-0591-2007 | FRAZIER Surgical Suction Instrument, 18 Fr. with Obturator, REF 0033180. MANUFACTURED... | ConMed Corporation | GCJ | ||
| Z-0590-2007 | FRAZIER Surgical Suction Instrument, 12 Fr. with Control Vent and Obturator, REF 0033120... | ConMed Corporation | GCJ | ||
| Z-0589-2007 | FRAZIER Surgical Suction Instrument, 10 Fr. with Control Vent and Obturator, REF 0033100... | ConMed Corporation | GCJ | ||
| Z-0588-2007 | FRAZIER Surgical Suction Instrument, 8 Fr. with Control Vent and Obturator, REF 0033080... | ConMed Corporation | GCJ | ||
| Z-0587-2007 | FRAZIER Atraumatic Soft Tip Surgical Suction Instrument with Control Vent and Obturator... | ConMed Corporation | GCJ | ||
| Z-0586-2007 | FRAZIER Surgical Suction Instrument, 7 Fr. with Control Vent and Obturator, REF 0031070... | ConMed Corporation | GCJ | ||
| Z-0585-2007 | FRAZIER Surgical Suction Instrument, 5 Fr. with Control Vent and Obturator, REF 0031050... | ConMed Corporation | GCJ | ||
| Z-0584-2007 | FRAZIER Surgical Suction Instrument, 3 Fr. with Control Vent and Obturator, REF 0031030... | ConMed Corporation | GCJ | ||
| Z-0350-2007 | Jostra Heater Cooler Unit HCU30, system version 1.02-Low voltage machine | Maquet Cardiovascular Us Sales, LLC | DWC | ||
| Z-0466-2007 | BOLD/INI-CLIP 2.2mm Drill Bit with AO Attachment. | Integra LifeSciences Corporation | HTW | ||
| Z-0307-2007 | Terumo Advanced Perfusion System 1; 220V -240V; Model 801764 (sold outside of the U.S... | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-0306-2007 | Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A... | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-0645-2007 | ADVIA Centaur CP System, Catalog/Part Number 086-A001. Automated Immunoassay Analyzer... | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-0504-2007 | Stille Sonesta Video Fluoroscopy Table 6210; manufactured by Stille AB, Solna, Sweden. | Stille Surgical Inc. | IXR | ||
| Z-0455-2007 | HiZel, Trayless-sterile hydrogel wound dressing. Sizes 2.4 x 2.4'', 2.4 x 4.7'', & 4.7... | Embeem Inc. | NAE | ||
| Z-0221-2007 | AccuSeed DS Digital Stepper, an accessory to a prostate radiation treatment planning... | Elekta Limited | ITX | ||
| Z-2427-2008 | Mainline Confirms Strep A, Group A Streptococcus; A rapid one-step visual test for the... | Mainline Technology, Inc. | GTY | ||
| Z-0381-2007 | Terumo Advanced Perfusion System 1 Integrated Centrifugal System Control Unit; Catalog... | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-0500-2007 | Atrium Express Dry Seal Chest Drain with Sterile Fluid Path Package Model Number... | Atrium Medical Corporation | CAC | ||
| Z-0310-2007 | Endologix Infrarenal Bifurcated Powerlink System with Visifiex Delivery System... | Endologix LLC | MIH | ||
| Z-0309-2007 | Endologix Infrarenal Bifurcated Powerlink System with Visifiex Delivery System... | Endologix LLC | MIH | ||
| Z-1989-2012 | Class II | The Axcess Cranial Screw (sometimes referred to as the Axcess Cranial Pin) is a... | GE Healthcare | HAW | |
| Z-0467-2007 | Simplex P with Tobramycin. Antibiotic PMMA Bone Cement. | Howmedica Osteonics Corp | MBB | ||
| Z-0288-2007 | OptiVantage DH Power Injection System. | Mallinckrodt, Inc. | CXT | ||
| Z-0251-2007 | Level 1 Normothermic I.V. Fluid Administration Set REF DI-60HL (Foreign Distribution Only) | Abbott Medical | FPA | ||
| Z-0250-2007 | Level 1 Normothermic I.V. Fluid Administration Set REF D-60HL | Abbott Medical | FPA | ||
| Z-0355-2007 | TraXis Fixed Rasp in sizes: 7mm, 9mm, 11mm, 13mm and 15mm; for use with TraXis vertebral... | Spinal Concepts, Inc. | MQP | ||
| Z-0354-2007 | TraXis Fixed Trial in sizes: 7mm, 9mm, 11mm, 13mm and 15mm; part of TraXis vertebral body... | Spinal Concepts, Inc. | MQP | ||
| Z-0014-2007 | Brilliance(a) CT 6 slice, Model #4535 670 73191. Brilliance(a) CT 10 Slice, Model 4535... | Philips North America LLC | KPS | ||
| Z-0013-2007 | Nuclear medicine systems: Gemini 16, Model 4535 679 28961. Gemini GXL, Models # 4535... | Philips North America LLC | KPS | ||
| Z-0300-2007 | BCI 3404 Autocorr Plus Pulse Oximeter/ECG/Respiration Monitor. Smiths Medical PM, Inc... | Abbott Medical | DQA | ||
| Z-1126-2007 | Laser Distance and Level Transmitters, Model No. LM02, K-Teck, 18321 Swamp road... | K Tek | K--DD |