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-1080-2008 | RP Diaphragm Exhalation model number FC06372. Filter, mask, and/or accessories for... | Respironics, Inc. | CBK | ||
| Z-1079-2008 | Non-continuous ventilator accessories under the following brand names: a) RP-ComfortGel... | Respironics, Inc. | BZD | ||
| Z-1078-2008 | RP C-Flex Mini Din Plug model number 1011220. Filter, mask, and/or accessories for... | Respironics, Inc. | BZD | ||
| Z-1077-2008 | RP-Cable DC 6 w/Ring PLV RBL POR model number FC07270. Filter, mask, and/or accessories... | Respironics, Inc. | CBK | ||
| Z-1076-2008 | Non-continuous ventilator accessories under the following brand names: a) RP-BIPAP Flow... | Respironics, Inc. | BZD | ||
| Z-1075-2008 | RP-Assy, Cover, DC-5 pack model number F35933. Filter, mask, and/or accessories for... | Respironics, Inc. | BZD | ||
| Z-1074-2008 | Power Supply under the following brand names: a) RP, Power Supply Assembly model number... | Respironics, Inc. | BZD | ||
| Z-1073-2008 | Non-continuous ventilator accessories under the following brand names: a) RP-P ComfortGel... | Respironics, Inc. | BZD | ||
| Z-1072-2008 | RP M Series Pollen Filter Kit 1 pack model number 1035443. Filter, mask, and/or... | Respironics, Inc. | BZD | ||
| Z-1071-2008 | Non-continuous ventilator accessories under the following brand names: a) RP-L ComfortGel... | Respironics, Inc. | BZD | ||
| Z-1070-2008 | Rotating Connector Packaged model number 302209. Filter, mask, and/or accessories for... | Respironics, Inc. | CBK | ||
| Z-1069-2008 | Non-continuous ventilator accessories under the following brand names: a) REMStar Pro2... | Respironics, Inc. | BZD | ||
| Z-1068-2008 | Non-continuous ventilator accessories under the following brand names: a) REMStar Plus M... | Respironics, Inc. | BZD | ||
| Z-1067-2008 | Non-continuous ventilator accessories under the following brand names: a) REMStar M US... | Respironics, Inc. | BZD | ||
| Z-1066-2008 | REMStar Heated Humidifier Pkg model number 1005792. Filter, mask, and/or accessories... | Respironics, Inc. | BZD | ||
| Z-1065-2008 | Non-continuous ventilator accessories under the following brand names: a) REMStar (Tower)... | Respironics, Inc. | BZD | ||
| Z-1064-2008 | Non-continuous ventilators accessories under the following brand names: a) REM Auto M... | Respironics, Inc. | BZD | ||
| Z-1063-2008 | Power Cord Accessory under the following brand names a) Power Cord W/C7 End Europe 5 ft... | Respironics, Inc. | BZD | ||
| Z-1062-2008 | PLV-102, 100V 50/60 HZ Japanese model number 87006. Filter, mask, and/or accessories... | Respironics, Inc. | CBK | ||
| Z-1061-2008 | Omni Lab Core Domestic model number 1043343. Filter, mask, and/or accessories for sleep... | Respironics, Inc. | MNS | ||
| Z-1060-2008 | Mouthpiece, Angled 22mm CE model number FC06566. Filter, mask, and/or accessories for... | Respironics, Inc. | CBK | ||
| Z-1059-2008 | M Series Heated Humidifier Domestic model number 1022257. Filter, mask, and/or... | Respironics, Inc. | BZD | ||
| Z-1058-2008 | Inv Circuit Assembly Box 10 CE model number 652002. Filter, mask, and/or accessories... | Respironics, Inc. | MNT | ||
| Z-1057-2008 | Non-continuous ventilator accessories under the following brand names: a) Adult ECG... | Respironics, Inc. | GWQ | ||
| Z-1056-2008 | Filters under the following brand names: a) filter std incoming 7100 CPAP qty 1 model... | Respironics, Inc. | BZD | ||
| Z-0723-2008 | PML --IDS Rapid NH QC Set- Quality Control kit for culture media. Product label includes... | PML, Inc. dba Pml Microbiologicals Inc. | JTR | ||
| Z-0722-2008 | PML -- Vitek NH ID Card (NHI) Set - Quality Control kit for culture media. Each kit... | PML, Inc. dba Pml Microbiologicals Inc. | JTR | ||
| Z-1055-2008 | BIPAP AUTO, CORE PACKAGE NA, model number 1017442, filter, mask, and/or accessories for... | Respironics, Inc. | BZD | ||
| Z-0721-2008 | PML -- LyfoCults Haemophilus parainfluenzae - micro organism. Product label includes... | PML, Inc. dba Pml Microbiologicals Inc. | JTR | ||
| Z-0619-2008 | Allogenix; DBM in a Lipid Carrier with Calcium Granules; Model Numbers: 02-3110... | Interpore Cross International Inc | MQV | ||
| Z-0618-2008 | InterGro PLUS; DBM in a Lipid Carrier with Calcium Granules; Model Numbers: DBM002... | Interpore Cross International Inc | MQV | ||
| Z-0358-2008 | Haemonetics cardioPAT System, Product List Number 02050, Haemonetics Corporation... | Haemonetics Corporation | CAC | ||
| Z-0070-2008 | Medtronic Sprint Fidelis 6949 Steroid eluting, quadripolar, screw-in, ventricular lead... | Medtronic, Inc. | LWS | ||
| Z-0069-2008 | Medtronic Sprint Fidelis 6948 Steroid eluting, quadripolar, ventricular lead with tined... | Medtronic, Inc. | LWS | ||
| Z-0068-2008 | Medtronic Sprint Fidelis 6931 Steroid eluting, tripolar, screw-in, ventricular lead with... | Medtronic, Inc. | LWS | ||
| Z-0067-2008 | Medtronic Sprint Fidelis 6930 Steroid eluting, tripolar, ventricular lead with tined tip... | Medtronic, Inc. | LWS | ||
| Z-0261-2008 | ARJO,Carendo Multi-Purpose Hygiene Chair; Model BIB2003-01, a non-AC powered patient... | Arjo, Inc. | FSA | ||
| Z-1109-2008 | Abbott Clinical Chemistry Creatine Kinase, Model LN 7D63-30, Lot Number: 52044HW00... | Abbott Medical | CGS | ||
| Z-0456-2008 | MicroBiologics; P. vulgaris, DuoPacksl Product Catalog Number: 0691P; ARCC 0427; Exp... | Microbiologics, Inc. | JTR | ||
| Z-0279-2008 | Boston Scientific, Imager II Angiographic Catheter, (Outer Carton Label): UPN... | Boston Scientific Corporation | DQO | ||
| Z-2402-2010 | CareGuard Mattress Models CG10180 and CG10180A used with IVC and ValueCare Series of... | Invacare GmbH | FMW | ||
| Z-0129-2009 | Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.2, Part Number: 626553... | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-0843-2008 | Nonin Model 2500 PalmSAT handheld pluse Oximeter , Nonin Medical, Inc., Plymouth, MN USA | Nonin Medical, Inc | DQA | ||
| Z-0291-2008 | Pioneer Quantum Spinal Rod System, MIS Yoke Manipulator, Long Slot, non-sterile; Cat #... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | HWR | ||
| Z-0445-2008 | Excia Cemented Hip Stems ,Size 18mm, Part Number NJ318K, Aesculap Implant Systems, Inc... | Aesculap Inc | LWJ | ||
| Z-0444-2008 | Excia Cemented Hip Stems, Size 17mm, Part Number : NJ317K, Aesculap Implant Systems... | Aesculap Inc | LWJ | ||
| Z-0443-2008 | Excia Cemented Hip Stems, Size 16mm, Part Number NJ316K, Aesculap Implant Systems, Inc... | Aesculap Inc | LWJ | ||
| Z-0442-2008 | Excia Cemented Hip Stems, Size 15mm, Part Number: NJ315K Aesculap Implant Systems, Inc... | Aesculap Inc | LWJ | ||
| Z-0441-2008 | Excia Cemented Hip Stems, Size 14mm, Part Number : NJ314K, Aesculap Implant Systems... | Aesculap Inc | LWJ | ||
| Z-0440-2008 | Excia Cemented Hip Stems, Size 13mm, Part Number : NJ313K, Aesculap Implant Systems... | Aesculap Inc | LWJ |