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-0594-2009 | Ossur 3'" Titanium Skull Pin, 1 pack, Model Number: 516V2S | Ossur Iceland ehf. | LYT | ||
| Z-0274-2009 | PurePoint System Operator's Manual, Catalog Number 8065751131, Rev. B for use with the... | Alcon Laboratories | HQF | ||
| Z-1090-2009 | BD PrepStain System, Model Number: 799-14000-00; Catalog Number: 05CR000021, 05CR00021R... | BD Diagnostic Systems Tripath | MKQ | ||
| Z-0161-2009 | Accessory Head Rest for Alphastar Operating Tables | Maquet Cardiovascular Us Sales, LLC | FQO | ||
| Z-0622-2009 | Genicon 5mm Pyramidal Trocar, Sterile, Genion 6869 Stapoint Court, Suite 114 Winter Park... | Genicon, Inc. | GEA | ||
| Z-0456-2009 | GE Healthcare Centricity Perinatal (formerly Quantitative Sentinel) System - Alert and... | GE Healthcare | HGM | ||
| Z-0112-2009 | Centricity Perinatal (formerly Quantitative Sentinel) System - Fluid Total Precision... | GE Healthcare | HGM | ||
| Z-0460-2009 | GE Centricity PACS RA1000 Workstation (for diagnostic image analysis). GE Healthcare... | GE Healthcare | LLZ | ||
| Z-0449-2009 | Hologic, Inc., 10 Year Fracture Risk Questionnaire Option for QDR X-Ray Bone... | Hologic, Inc. | KGI | ||
| Z-0288-2009 | Biomet 2.0 MM Stainless Steel (SS) Crimp Sleeve, sterile, use w/2.0 MM S.S. cable #... | Zimmer GmbH | JDQ | ||
| Z-2235-2009 | Sorin Group Reply DR Rate responsive dual-chamber pacemaker. Made in Italy by: Sorin... | Ela Medical, Inc. | NVZ | ||
| Z-0597-2009 | Vertical drive brake (on patient supports). Used on certain Philips Medical Systems MX... | Philips North America LLC | KPS | ||
| Z-0438-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00225W, 18F, 4.4cm... | Bard Access Systems, Inc. | KNT | ||
| Z-0437-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00224W, 18F, 3.4cm... | Bard Access Systems, Inc. | KNT | ||
| Z-0436-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00223W, 18F, 2.4cm... | Bard Access Systems, Inc. | KNT | ||
| Z-0435-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00222W, 18F, 1.7cm... | Bard Access Systems, Inc. | KNT | ||
| Z-0434-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00221W, 18F, 1.2cm... | Bard Access Systems, Inc. | KNT | ||
| Z-0433-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00219W, 24F, 4.4cm... | Bard Access Systems, Inc. | KNT | ||
| Z-0432-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00218W, 24F, 3.4cm... | Bard Access Systems, Inc. | KNT | ||
| Z-0431-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00217W, 24F, 2.4cm... | Bard Access Systems, Inc. | KNT | ||
| Z-0430-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00216W, 24F, 1.7cm... | Bard Access Systems, Inc. | KNT | ||
| Z-0429-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00215W, 20F, 4.4cm... | Bard Access Systems, Inc. | KNT | ||
| Z-0428-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00214W, 20F, 3.4cm... | Bard Access Systems, Inc. | KNT | ||
| Z-0427-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00213W, 20F, 2.4cm... | Bard Access Systems, Inc. | KNT | ||
| Z-0426-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00212W, 20F, 1.7cm... | Bard Access Systems, Inc. | KNT | ||
| Z-0425-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00210W, 16F, 2.4cm... | Bard Access Systems, Inc. | KNT | ||
| Z-0424-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00209W, 16F, 1.7cm... | Bard Access Systems, Inc. | KNT | ||
| Z-0423-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00207W, 20F, 4.4cm... | Bard Access Systems, Inc. | KNT | ||
| Z-0422-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00206W, 20F, 3.4cm... | Bard Access Systems, Inc. | KNT | ||
| Z-0421-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00205W, 20F, 2.4cm... | Bard Access Systems, Inc. | KNT | ||
| Z-0420-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00204W, 20F, 1.7cm... | Bard Access Systems, Inc. | KNT | ||
| Z-0419-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00203W, 20F, 1.2cm... | Bard Access Systems, Inc. | KNT | ||
| Z-0418-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00202W, 16F, 2.4cm... | Bard Access Systems, Inc. | KNT | ||
| Z-0417-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00201W, 16F, 1.7cm... | Bard Access Systems, Inc. | KNT | ||
| Z-0416-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00200W, 16F, 1.2cm... | Bard Access Systems, Inc. | KNT | ||
| Z-1606-2009 | Respironics BiPAP Focus Noninvasive Ventilator System. The BiPAP Focus is a... | Respironics, Inc. | MNS | ||
| Z-0669-2009 | HARDY DIAGNOSTIC McFarland Standard 0.5; in vitro diagnostic, glass vial, one vial per box | Trek Diagnostic Systems, Ltd. | JTZ | ||
| Z-0289-2009 | Biomet Vanguard(TM) DCM PS Plus 16mm x 63/67mm Tibial Bearing (REF. 183726), ARCOM... | Zimmer GmbH | JWH | ||
| Z-0275-2009 | ATEC Breast Biopsy and Excision System 12 gauge, 20 centimeter handpiece, sterile... | Hologic, Inc. | KNW | ||
| Z-0626-2009 | Pre Isotonic Personal Lubricant labeled PRE' Patient Lubricant. Product is used to... | Ingfertility, LLC | NUC | ||
| Z-0196-2009 | 26" Vision Elect HDTV Surgical Viewing Monitor, model number 0240030960, Manufactured by... | Stryker Corp. | GCJ | ||
| Z-0271-2009 | Precision Charger 1.0 (Model Number SC-5300) for the Precision Spinal Cord Stimulator... | Advanced Bionics LLC | LGW | ||
| Z-0132-2009 | Respiratory Gating System which includes: Pulmonary Digital Assembly Kit and Pulmonary... | Philips North America LLC | KPS | ||
| Z-0472-2009 | GE Centricity Ultra Laboratory System Software; for recording, reporting and distribution... | GE Healthcare | JQP | ||
| Z-0471-2009 | CASMED 500cc Unifusor Classic with aneroid gauge and thumbwheel valve. Model: D803FGA... | Cas Medical Systems, Inc. | KZD | ||
| Z-0470-2009 | CASMED 500cc Unifusor II with aneroid gauge and thumbwheel valve. Private labeled for... | Cas Medical Systems, Inc. | KZD | ||
| Z-0469-2009 | CASMED 500cc Unifusor with a short tube. Private labeled for King Systems. Model... | Cas Medical Systems, Inc. | KZD | ||
| Z-0468-2009 | CASMED 500cc Unifusor Classic with aneroid gauge and thumbwheel valve Model:FN-803FGA... | Cas Medical Systems, Inc. | KZD | ||
| Z-0467-2009 | CASMED 500cc Unifusor Classic with piston gauge and stopcock valve Model: 903SGA. It is... | Cas Medical Systems, Inc. | KZD | ||
| Z-0466-2009 | CASMED 500cc Unifusor Classic with piston gauge and stopcock valve. Model : A903SGA... | Cas Medical Systems, Inc. | KZD |