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-0166-2008 | ONCOR IMPRESSION Plus,Medical charge-particle radiation therapy system (Medical Digital... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0165-2008 | ONCOR Expression,Medical charge-particle radiation therapy system (Medical Digital Linear... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0164-2008 | ONCOR Avant Garde,Medical charge-particle radiation therapy system (Medical Digital... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0163-2008 | MEVATRON MDX-2,Medical charge-particle radiation therapy system (Medical Digital Linear... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0162-2008 | MEVATRON MD-2,Medical charge-particle radiation therapy system (Medical Digital Linear... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0161-2008 | MEVATRON M-2 6740,Medical charge-particle radiation therapy system (Medical Digital... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0160-2008 | MEVATRON M-2 6700,Medical charge-particle radiation therapy system (Medical Digital... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0159-2008 | MEVATRON M-2 6300,Medical charge-particle radiation therapy system (Medical Digital... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0158-2008 | MEVATRON KDS-2,Medical charge-particle radiation therapy system (Medical Digital Linear... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0157-2008 | MEVATRON KDS,Medical charge-particle radiation therapy system (Medical Digital Linear... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0156-2008 | MEVATRON KD-2,Medical charge-particle radiation therapy system (Medical Digital Linear... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-1260-2007 | Reverse Shoulder Prosthesis (RSP) device component; 40mm + 4mm RSP Socket Device; Device... | Encore Medical, LP | KWS | ||
| Z-1259-2007 | Reverse Shoulder Prosthesis (RSP) device component; RSP Socket; Device manufactured by... | Encore Medical, LP | KWS | ||
| Z-1258-2007 | Reverse Shoulder Prosthesis (RSP) device component; RSP Head; Device manufactured by... | Encore Medical, LP | KWS | ||
| Z-1257-2007 | Reverse Shoulder Prosthesis (RSP) device component; RSP Baseplate; Device manufactured by... | Encore Medical, LP | KWS | ||
| Z-1256-2007 | Reverse Shoulder Prosthesis (RSP) device component; RSP Stem; Device manufactured by... | Encore Medical, LP | KWS | ||
| Z-1255-2007 | Reverse Shoulder Prosthesis (RSP) custom device component; RSP/Foundation Socket Spacer... | Encore Medical, LP | KWS | ||
| Z-1254-2007 | Reverse Shoulder Prosthesis (RSP) custom device component; RSP RSP 40mm Socket Assembly... | Encore Medical, LP | KWS | ||
| Z-1253-2007 | Reverse Shoulder Prosthesis (RSP) custom device component; RSP 40mm Poly Socket Assembly... | Encore Medical, LP | KWS | ||
| Z-1252-2007 | Reverse Shoulder Prosthesis (RSP) custom device component; 40mm Glenoid Head; Custom... | Encore Medical, LP | KWS | ||
| Z-1251-2007 | Reverse Shoulder Prosthesis (RSP) custom device component; 36mm Glenoid Head, Hooded... | Encore Medical, LP | KWS | ||
| Z-1250-2007 | Reverse Shoulder Prosthesis (RSP) custom device component; 36mm RSP Glenoid Head; Custom... | Encore Medical, LP | KWS | ||
| Z-1249-2007 | Reverse Shoulder Prosthesis (RSP) custom device component; 32mm RSP Glenoid Baseplate... | Encore Medical, LP | KWS | ||
| Z-1248-2007 | Reverse Shoulder Prosthesis (RSP) custom device component; 32mm Neutral Socket; Custom... | Encore Medical, LP | KWS | ||
| Z-1247-2007 | Reverse Shoulder Prosthesis (RSP) custom device component; 30mm RSP Glenoid Baseplate... | Encore Medical, LP | KWS | ||
| Z-0155-2008 | MEVATRON KD2,Medical charge-particle radiation therapy system (Medical Digital Linear... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-1193-2007 | Amsco Century Medium Steam Sterilizer (26" x 37.5") (660 x 950mm). | STERIS Corporation | FLE | ||
| Z-1042-2007 | OneTouch Ultra Test strip, a component of the following OneTouch Ultra Glucose monitoring... | Lifescan, Inc. | NBW | ||
| Z-0174-2008 | Electric Mobility Corporation (EMC)- Scooters and Turnabout Powerchairs with either an... | Electric Mobility | INI | ||
| Z-1246-2007 | Reverse Shoulder Prosthesis (RSP) custom device component; 30mm Locking Screw; Custom... | Encore Medical, LP | KWS | ||
| Z-0364-2008 | Accuray, Multiplan Treatment Planning Software, Versions 2.0, 2.0.1 .6, 1.6.1, 1.6..1 or... | Accuray Incorporated | MUJ | ||
| Z-0751-2007 | Mobilett XP, mobile X-ray system, Model number 1818363 | Siemens Medical Solutions USA, Inc. | IZL | ||
| Z-0750-2007 | Mobilett XP, mobile X-ray system, Model number 1818447 | Siemens Medical Solutions USA, Inc. | IZL | ||
| Z-0749-2007 | Mobilett XP, mobile X-ray system, Model number 1818454 | Siemens Medical Solutions USA, Inc. | IZL | ||
| Z-0933-2007 | St. Jude Medical-CPS Direct SL- slittable CRT lead delivery tool. -Model Numbers 410110... | Abbott Medical | MCX | ||
| Z-1056-2007 | TDx/TDxFLx Methotrexate II Reagent-List Number 07A12-60 - a reagent system for In Vitro... | Abbott Diagnostic International, Ltd. | LAO | ||
| Z-0777-2007 | BD Vacutainer Safety-Lok Blood Collection Set with Preattached Holder. Color green. 21... | Becton Dickinson & Co | JKA | ||
| Z-0179-2008 | Edwards Lifesciences LifeStent FlexStar Bilary Stent System Application, Model... | Edwards Lifesciences LLC | FGE | ||
| Z-0966-2007 | Invacare Storm TDX Power Wheelchair, Models: #TDX3-PS, TDX3-SE-PS, TDX4-PS. | Invacare GmbH | ITI | ||
| Z-0053-2008 | Guidant CONTAK RENEWAL 3 AVT (Models M150, M155) Guidant CONTAK RENEWAL 3 AVT HE (Models... | Boston Scientific Corporation | LWP | ||
| Z-0052-2008 | Guidant CONTAK RENEWAL 3 (Models H170, H173, H175), Guidant CONTAK RENEWAL 3 HE (Models... | Boston Scientific Corporation | LWP | ||
| Z-0051-2008 | Guidant VITALITY 2 DR/VR (Models T165, T175) and Guidant VITALITY 2 EL DR/VR (Models... | Boston Scientific Corporation | LWP | ||
| Z-0050-2008 | Guidant VITALITY DS DR/VR (Models T125, T135), Guidant VITALITY EL (Model T127), Guidant... | Boston Scientific Corporation | LWP | ||
| Z-0049-2008 | Guidant ASSURE, Model B301, Implantable Cardioverter Defibrillator, ICD. (This model is... | Boston Scientific Corporation | LWP | ||
| Z-0048-2008 | Guidant VITALITY AVT, Models A135 and A155. Implantable Cardioverter Defibrillator... | Boston Scientific Corporation | LWP | ||
| Z-0047-2008 | Guidant VITALITY VR/DR, Implantable Cardioverter Defibrillator, ICD, Models 1870 and... | Boston Scientific Corporation | LWP | ||
| Z-0965-2007 | Synovis Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement... | SYNOVIS LIFE TECHNOLOGIES, Inc. (A Subsidiary of Baxter International Inc.) | FTM | ||
| Z-0964-2007 | Synovis Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement... | SYNOVIS LIFE TECHNOLOGIES, Inc. (A Subsidiary of Baxter International Inc.) | FTM | ||
| Z-0963-2007 | Synovis Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement... | SYNOVIS LIFE TECHNOLOGIES, Inc. (A Subsidiary of Baxter International Inc.) | FTM | ||
| Z-0962-2007 | Synovis Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement... | SYNOVIS LIFE TECHNOLOGIES, Inc. (A Subsidiary of Baxter International Inc.) | FTM |