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-0452-2011 | DuraGen XS Dural Regeneration Matrix: 4 inches x 5 inches. Non Pyrogenic; Rx only;Integra... | Integra LifeSciences Corporation | GXQ | ||
| Z-0451-2011 | DuraGen XS Dural Regeneration Matrix: 3 inches x 3 inches. Non Pyrogenic; Rx only;Integra... | Integra LifeSciences Corporation | GXQ | ||
| Z-0450-2011 | DuraGen XS Dural Regeneration Matrix: 2 inches x 2 inches. Non Pyrogenic; Rx only;Integra... | Integra LifeSciences Corporation | GXQ | ||
| Z-0906-2011 | InfraVision IR Illuminator Console, model number 220-180-521, manufactured by Stryker... | Stryker Corp. | FGS | ||
| Z-2658-2011 | BD ProbeTec" CT/GC/AC Reagent Pack, catalog #440450, labeled in part ***Becton Dickinson... | Becton Dickinson & Co | MKZ | ||
| Z-1498-2011 | SSH-880CV Aplio Artida; System, Diagnostic Ultrasound | Canon Medical Systems USA, Inc. | IYO | ||
| Z-1394-2011 | Maquet Cardiopulmonary AG, MAQUET RPM 20: Roller Pump for Heart Lung Machine HL20. | Maquet Cardiovascular Us Sales, LLC | DTQ | ||
| Z-0837-2012 | SeraQuest***CMV IgM TEST SET For the detection of CMV IgM Antibodies 96 Test Set Cat. No... | Quest International, Inc. | LKQ | ||
| Z-0551-2011 | Dixtal Handheld Pulse Oximetry Model 512 Catalog Number: 9100-00 | Dixtal Medical, Inc. | DQA | ||
| Z-0550-2011 | Dixtal Handheld Pulse Oximetry Model 513 Catalog Number: 9300-00 | Dixtal Medical, Inc. | DQA | ||
| Z-0417-2011 | Rascal UltraLite 370B manufactured by Giant Manufacturing, Taiwan. | Electric Mobility | INI | ||
| Z-0416-2011 | Rascal LiteWay 224 manufactured by Giant Manufacturing, Taiwan. | Electric Mobility | INI | ||
| Z-0928-2011 | Scorpio Fixed Femoral A/P Sizing Guide; non-sterile instruments; Howmedica Osteonics... | Howmedica Osteonics Corp | LXH | ||
| Z-0304-2011 | Velocity" Injection Port and Applier Product Code PT2XV, Lot #: 1110603, 10060505... | Ethicon Endo-Surgery Inc | LTI | ||
| Z-0303-2011 | SAGB VC Swedish Adjustable Gastric Band including Velocity" Injection Port Applier... | Ethicon Endo-Surgery Inc | LTI | ||
| Z-0302-2011 | SAGB QuickClose Swedish Adjustable Gastric Band including Velocity" Injection Port and... | Ethicon Endo-Surgery Inc | LTI | ||
| Z-0301-2011 | REALIZE Injection Port and Applier. Product Code RLZPT2, Lot #: ZHLBCG, ZHPBB8, ZJBBBD... | Ethicon Endo-Surgery Inc | LTI | ||
| Z-0300-2011 | REALIZE Adjustable Gastric Band-C with Endoscopic Dissector. Product Code RLZB32D1, Lot... | Ethicon Endo-Surgery Inc | LTI | ||
| Z-0299-2011 | REALIZE Adjustable Gastric Band-C Pak with Endoscopic Dissector, Calibration Tube and... | Ethicon Endo-Surgery Inc | LTI | ||
| Z-0298-2011 | REALIZE Adjustable Gastric Band-C Pak with Endoscopic Dissector and calibration tube... | Ethicon Endo-Surgery Inc | LTI | ||
| Z-0297-2011 | REALIZE Adjustable Gastric Band-C Pak with Endoscopic Dissector and 15mm XCEL" trocar... | Ethicon Endo-Surgery Inc | LTI | ||
| Z-0296-2011 | REALIZE Adjustable Gastric Band-C Pak with 15mm XCEL" trocar Product Code RLZB32T, Lot #... | Ethicon Endo-Surgery Inc | LTI | ||
| Z-0295-2011 | REALIZE Adjustable Gastric Band-C Product Code RLZB32, Lot #: ZJMBP7, ZJMBP8, ZJMBP9... | Ethicon Endo-Surgery Inc | LTI | ||
| Z-0294-2011 | REALIZE Adjustable Gastric Band Pak with Endoscopic Dissector, Calibration Tube and 15mm... | Ethicon Endo-Surgery Inc | LTI | ||
| Z-0293-2011 | REALIZE Adjustable Gastric Band Pak with Endoscopic Dissector and Calibration Tube... | Ethicon Endo-Surgery Inc | LTI | ||
| Z-0292-2011 | REALIZE Adjustable Gastric Band Pak with Endoscopic Dissector and 15mm XCEL" trocar... | Ethicon Endo-Surgery Inc | LTI | ||
| Z-0291-2011 | REALIZE Adjustable Gastric Band Pak with Endoscopic Dissector Product Code RLZB22D1, Lot... | Ethicon Endo-Surgery Inc | LTI | ||
| Z-0290-2011 | REALIZE Adjustable Gastric Band Pak with 15mm XCEL" trocar Product Code RLZB22T, Lot #... | Ethicon Endo-Surgery Inc | LTI | ||
| Z-0289-2011 | REALIZE Adjustable Gastric Band, Injection Port and Applier Product Code: RLZB22... | Ethicon Endo-Surgery Inc | LTI | ||
| Z-0415-2011 | Rascal LiteWay 214 manufactured by Giant Manufacturing, Taiwan. | Electric Mobility | INI | ||
| Z-0336-2011 | ENDOPATH XCEL" with OPTIVIEW" Technology trocar Product Codes: Product Code #... | Ethicon Endo-Surgery Inc | DRC | ||
| Z-0927-2011 | Scorpio Adjustable Femoral A/P Sizing Guide Assembly; non-sterile instruments; Howmedica... | Howmedica Osteonics Corp | LXH | ||
| Z-0170-2011 | Boston Scientific Peristaltic Tubing Kit, Model 2104, UPN M0043521040. For use with... | Boston Scientific Corporation | LPB | ||
| Z-0406-2011 | Triumph-1, AngioDynamics, Inc., One Horizon Way, Manchester, GA 31816. | Boston Scientific Corporation | FRN | ||
| Z-0405-2011 | LifePort, AngioDynamics, Inc., One Horizon Way, Manchester, GA 31816. | Boston Scientific Corporation | FRN | ||
| Z-0404-2011 | Vortex LP, AngioDynamics, Inc., One Horizon Way, Manchester, GA 31816 | Boston Scientific Corporation | FRN | ||
| Z-0403-2011 | Vortex TR, AngioDynamics, Inc., One Horizon Way, Manchester, GA 31816 | Boston Scientific Corporation | FRN | ||
| Z-0402-2011 | Vortex VX Port, AngioDynamics, Inc., One Horizon Way, Manchester, GA 31816 | Boston Scientific Corporation | FRN | ||
| Z-2344-2012 | Class II | Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient... | Medtronic Xomed, Inc. | GWF | |
| Z-2343-2012 | Class II | Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient... | Medtronic Xomed, Inc. | GWF | |
| Z-2342-2012 | Class II | Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient... | Medtronic Xomed, Inc. | GWF | |
| Z-0625-2011 | Model 4000 Monitor component of the LifeVest Wearable Defibrillator | ZOLL Manufacturing Corporation | MVK | ||
| Z-0427-2011 | Belzer UW Cold Storage Solution, 1000 mL. Sterile and non-pyrogenic. Formulated for... | Preservation Solutions Inc | KDN | ||
| Z-0145-2011 | Vertex Max Drill Guide, Catalog Number 9732355, to be used with a Medtronic... | Medtronic Navigation, Inc | HAW | ||
| Z-0622-2011 | ThermaCare Menstrual 8 Hour Heat Wraps, 3 count, NDC 0573-3020-02, SKU: 302002, UPC... | Pfizer Global | IMD | ||
| Z-1735-2011 | Thermo Scientific HM 560 Cold Disinfection Cryostat, Microm International GmbH, Waldorf... | Thermo Fisher Scientific Oy | IDP | ||
| Z-1734-2011 | Thermo Scientific HM 550 Cold Disinfection Cryostat, Microm International GmbH, Waldorf... | Thermo Fisher Scientific Oy | IDP | ||
| Z-1493-2011 | Neotrode Wire Attached, Catalog Number: 1731-003; Neotrode II Wire Attached, Catalog... | ConMed Corporation | DRX | ||
| Z-3024-2011 | Spacelabs Medical elance Vital Signs Monitor, Model 93300. The Spacelabs elance Vital... | GE Healthcare | MHX | ||
| Z-0488-2011 | HeartStart FR2+ AED with Text Display, Model 989803148611. This product is G2005 Update... | Philips North America LLC | MKJ |