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-0879-03 | Pulsar Multiprogrammable Pacemaker, DDDR Model 1272 | Boston Scientific Corporation | DXY | ||
| Z-0878-03 | Pulsar Multiprogrammable Pacemaker, DDDR Model 1270 | Boston Scientific Corporation | DXY | ||
| Z-0877-03 | Pulsar Multiprogrammable Pacemaker, DDD Model 976 | Boston Scientific Corporation | DXY | ||
| Z-0876-03 | Pulsar Multiprogrammable Pacemaker, DDD Model 972 | Boston Scientific Corporation | DXY | ||
| Z-0875-03 | Pulsar Multiprogrammable Pacemaker, DDD Model 970 | Boston Scientific Corporation | DXY | ||
| Z-0827-03 | Focus DAILIES Toric (nelfilcon), One-Day Contact Lenses, Daily Disposable (hydrophilic)... | Alcon Laboratories | LPL | ||
| Z-0990-03 | CLINITRON UP-LIFT Air Fluidized Therapy unit. | Hill-Rom Manufacturing, Inc. | INX | ||
| Z-0989-03 | CLINITRON CII Air Fluidized Therapy unit. | Hill-Rom Manufacturing, Inc. | INX | ||
| Z-0941-03 | Product is Cordis Brite Tip Catheter Sheath Introducer (4, 7, 8, 9, 10 and 11French sizes... | Cordis US Corp. | DYB | ||
| Z-0988-03 | CryoValve Allograft, Aortic Valve & Conduit | Artivion, Inc. | MIE | ||
| Z-0861-03 | CryoValve Allograft, Pulmonary Heart valve & Conduit. | Artivion, Inc. | MIE | ||
| Z-0541-04 | Product is Magnivision UltraLights reading glasses which have the dioptic power on the... | FGX International Inc. | HQZ | ||
| Z-0904-03 | Dermagraft, Human Fibroblast -Derived Dermal Substitute, 2 in. by 3 in.. | Organogenesis, Inc. | MGR | ||
| Z-0868-03 | Stryker Secure II hospital bed; model 3002. | Stryker Medical | FNL | ||
| Z-0930-03 | Rejuv O2 Home Oxygen Spa 98% + Pure, Non-pressurized Oxygen for Breathing. Benefits of... | System 02 Inc | CAW | ||
| Z-0929-03 | System O2, Portable Humidified Oxygen Delivery System Over 99% pure humidified oxygen... | System 02 Inc | CAW | ||
| Z-0011-04 | Power cord manufactured by ElectriCord Manufacturing Company , P/N 316579, used with... | GE Medical Systems Information Technologies, Inc. | MWI | ||
| Z-0828-03 | Dr. Fog Endoscopic Fog Prevention Kit; model DF-3120. Each box contains 40 packages... | Aspen Surgical Products, Inc. | GCJ | ||
| Z-0866-03 | CryoValve Allograft, Heart valve | Artivion, Inc. | MIE | ||
| Z-0860-03 | GENT-L-KARE Sterile 3OZ. EAR/ULCER BULB SYRINGE SINGLE USE | Medegen Medical Products | KCP | ||
| Z-0859-03 | Gent-L-Kare Sterile Mid-Stream Urine Collector | Medegen Medical Products | FAQ | ||
| Z-0831-03 | MaxForce TTS High Performance Esophageal Balloon Dilatation Catheter 8mm/24 Fr | Boston Scientific Corporation | LIT | ||
| Z-1071-03 | Coulter Clone B6-FITC Reagent | Siemens Healthcare Diagnostics Inc. | |||
| Z-0901-03 | Trident Insert Impactor | Howmedica Osteonics Corp | HWA | ||
| Z-0871-03 | Elecsys Troponin T STAT; catalog number 2017423 | Roche Diagnostics GmbH | MMI | ||
| Z-0870-03 | Elecsys Troponin T; catalog number 2017644 | Roche Diagnostics GmbH | MMI | ||
| Z-1069-03 | Foundation Knee System, non-porous Femur Size 8, Right | Encore Medical, LP | JWH | ||
| Z-0903-03 | Hill-Rom brand Century+ series bed | Hill-Rom Inc. | KNC | ||
| Z-0902-03 | Hill-Rom brand Affinity three birthing bed | Hill-Rom Inc. | KNC | ||
| Z-1243-03 | Product is Anspach eMax Drill System console, catalog numbers SC-1000 and SC-1000-1... | The Anspach Effort, Inc. | HBC | ||
| Z-0830-03 | C1140 Flexible Endoscope Processing Container and Tray assembly. | STERIS Corporation | MLR | ||
| Z-0829-03 | C1141 Flexible Endoscope Processing Container, designed to fit the Steris System I... | STERIS Corporation | MLR | ||
| Z-0873-03 | Dimension TSPA (Total Prostate Specific Antigen) Flex Reagent Cartridge. The product is... | Siemens Healthcare Diagnostics Inc. | LTJ | ||
| Z-0984-03 | Axiom Aristos X-Ray System. | Siemens Medical Solutions USA, Inc. | KPR | ||
| Z-0272-05 | Intinion 1.5 T MRI Scanner. | Philips North America LLC | LNH | ||
| Z-0017-04 | TC-PLUS Solution Tibial Component-- Symmetric | Plus Endoprothetik AG | |||
| Z-0837-03 | SHPI LIftLoc Safety Infusion Sets | Specialized Health Products, Inc. | FPA | ||
| Z-0826-03 | Polyflex Esophageal Stent 25/21mm x 150mm | Boston Scientific Corporation | ESW | ||
| Z-0825-03 | Polyflex Esophageal Stent 25/21mm x 120mm | Boston Scientific Corporation | ESW | ||
| Z-0824-03 | Polyflex Esophageal Stent 25/21mm x 90mm | Boston Scientific Corporation | ESW | ||
| Z-0823-03 | Polyflex Esophageal Stent 23/18mm x 150mm | Boston Scientific Corporation | ESW | ||
| Z-0822-03 | Polyflex Esophageal Stent 23/18mm x 120mm | Boston Scientific Corporation | ESW | ||
| Z-0821-03 | Polyflex Esophageal Stent 23/18mm x 90mm | Boston Scientific Corporation | ESW | ||
| Z-0820-03 | Polyflex Esophageal Stent 20/16mm x 150mm | Boston Scientific Corporation | ESW | ||
| Z-0819-03 | Polyflex Esophageal Stent 20/16mm x 120mm | Boston Scientific Corporation | ESW | ||
| Z-0818-03 | Polyflex Esophageal Stent 20/16mm x 90mm | Boston Scientific Corporation | ESW | ||
| Z-0987-03 | 3D Ceiling Suspension | Siemens Medical Solutions USA, Inc. | IZF | ||
| Z-0982-03 | V*CARE, Infant Resuscitator, with 40 cm HO Pressure Limiting System & Pressure Port... | Salter Labs | BTM | ||
| Z-0016-04 | Acticoat* Moisture Control Dressing, Product Code 20211, Distributed by Smith & Nephew... | Smith & Nephew, Inc. | |||
| Z-0863-03 | Protg Self-Expanding Nitinol Stent 6 mm x 40 mm, Model Number SER6-6-40-135 | Medtronic, Inc. | FGE |