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-2119-2008 | 10mm Bone Graft Drill. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road... | Acumed LLC | HWC | ||
| Z-2118-2008 | 6mm Bone Graft Drill. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road... | Acumed LLC | HWC | ||
| Z-2117-2008 | Right Locking 1st MTP/MPJ Combo Fusion Plate. Product labeled in part, "ACUMED 5885 NW... | Acumed LLC | HWC | ||
| Z-2116-2008 | Left Locking 2st MTP/MPJ Combo Fusion Plate. Product labeled in part, "ACUMED 5885 NW... | Acumed LLC | HWC | ||
| Z-2115-2008 | Right Locking 1st MTP Revision Fusion Plate. Product labeled in part, "ACUMED 5885 NW... | Acumed LLC | HWC | ||
| Z-2114-2008 | Left Locking 1st MTP Revision Fusion Plate. Product labeled in part, "ACUMED 5885 NW... | Acumed LLC | HWC | ||
| Z-2113-2008 | Left Locking Dorsal 1st MTP Fusion Plate. Product labeled in part, "ACUMED 5885 NW... | Acumed LLC | HWC | ||
| Z-2112-2008 | Right Locking Proximal Metatarsal Wedge Plate. Product labeled in part, "ACUMED 5885 NW... | Acumed LLC | HWC | ||
| Z-2111-2008 | Left Locking Proximal Metatarsal Wedge Plate. Product labeled in part, "ACUMED 5885 NW... | Acumed LLC | HWC | ||
| Z-2110-2008 | 4 Hole Locking 2nd and 3rd Tarsometatarsal Plate. Product labeled in part, "ACUMED 5885... | Acumed LLC | HWC | ||
| Z-2109-2008 | 4 Hole Locking 1st Tarsometatarsal Plate. Product labeled in part, "ACUMED 5885 NW... | Acumed LLC | HWC | ||
| Z-2133-2008 | On-Q C-bloc 400 ml, 1-7 ml/hr Select-A-Flow + 5 ml/60 min ONDEMAND, REF CB005 indicated... | Halyard Health | MEB | ||
| Z-2108-2008 | 5 Hole Locking 1st Tarsometatarsal Plate. Product labeled in part, "ACUMED 5885 NW... | Acumed LLC | HWC | ||
| Z-1618-2008 | Boston Scientific SteeroCath-Dx Diagnostic Catheter, Manufactured by Boston Scientific... | Boston Scientific Corporation | DRF | ||
| Z-1617-2008 | Boston Scientific SteeroCath-T Ablation Catheter. This catheter is indicated for general... | Boston Scientific Corporation | DRF | ||
| Z-1366-2008 | BIOMET 3i, EP Healing Abutment, REF/Item Number: THA53, 4.1mm(D) X 5mm(P) X 3mm(H)... | ZimVie US Corp LLC | NHA | ||
| Z-1515-2008 | SEQUENCER, MOSAIQ versions 1.3 and 1.4 with Elekta and Siemens Machines, Model number... | Elekta Limited | IYE | ||
| Z-1179-2008 | Active Life Little Ones One-Piece Custom Urostomy Pouch 5/16 - 1 inch, 8-25mm; Ostomy... | ConvaTec Limited | EXB | ||
| Z-0359-2009 | Terumo Sarns Sternal Saw II System Power Unit, 220/240 V, Terumo Cardiovascular Systems... | Terumo Cardiovascular Systems Corporation | GFA | ||
| Z-0358-2009 | Terumo Sarns Sternal Saw II System Power Unit, 115 V, Terumo Cardiovascular Systems... | Terumo Cardiovascular Systems Corporation | GFA | ||
| Z-1369-2008 | EvoTech Endoscope Cleaner and Reprocessor, Product Code 50004-002 Indicated for use with... | Advanced Sterilization Products | FEB | ||
| Z-1368-2008 | EvoTech Endoscope Cleaner & Reprocessor, Product Code 50004 Indicated for use with high... | Advanced Sterilization Products | FEB | ||
| Z-1612-2008 | Eclipse Treatment Planning System, Client 8.1.18 and DCF 8.1.17, model number H48 | Varian Medical Systems, Inc. | MUJ | ||
| Z-1479-2008 | Sequoia Spinal System Surgical Kits; Pedicle screw spinal system; Non-sterile (kits... | Spinal Concepts, Inc. | NKB | ||
| Z-1195-2008 | Stryker VertePort , 11 G Cement Cannula, REF 306-510 , Qty 18; For use with the Stryker... | Stryker Corp. | JDZ | ||
| Z-1194-2008 | Stryker VertePort, 10 G Access Canula (short), REF 306-430, Qty 6; For use with the... | Stryker Corp. | JDZ | ||
| Z-1193-2008 | Stryker VertePort, 10 G Cement Cannula, REF 306-410, Qty 18; For use with the Stryker... | Stryker Corp. | JDZ | ||
| Z-1239-2008 | International Technidyne Corp. (ITC) AVOXimeter 4000 Co-oximeter, Catalog Numbers... | Accriva Diagnostics, Inc. | JKS | ||
| Z-1238-2008 | International Technidyne Corp. (ITC) AVOXimeter 1000E Oximeter, Catalog Numbers... | Accriva Diagnostics, Inc. | DQA | ||
| Z-1237-2008 | International Technidyne Corp. (ITC) AVOXimeter 1000 Oximeter, Catalog Numbers... | Accriva Diagnostics, Inc. | DQA | ||
| Z-1192-2008 | Stryker VertePort, 10 G Access Cannula w/Long Stylet System, REF 306-400, Qty 6; For use... | Stryker Corp. | JDZ | ||
| Z-1869-2008 | ON-Q PainBuster Infusion Pump (270 ml, 5 ml/hr), REF PS6504, Part No. 5001260. The pump... | Halyard Health | MEB | ||
| Z-1362-2008 | Biomet Vanguard Knee Instrumentation, Part Number: 32-487062, 67.5/70/75mm Sizing Wing... | Zimmer GmbH | HWT | ||
| Z-1178-2008 | Presource Standard Sterile OR Scissors; straight scissors, S/B, 5.5", made in Pakistan... | Medtronic, Inc. | LRW | ||
| Z-1198-2008 | Aspercreme, Pain Relieving Creme with Aloe, Maximum Strength Formula, Net Wt 3oz (85g)... | Chattem, Inc. | IMD | ||
| Z-1197-2008 | Icy Hot Heat Therapy , Air Activated Heat Patch, Arm, Neck and Leg and Small Areas, UPC... | Chattem, Inc. | IMD | ||
| Z-1196-2008 | Icy Hot Heat Therapy , Air Activated Heat Patch, Back and Large Areas, UPC Code... | Chattem, Inc. | IMD | ||
| Z-1376-2008 | Biomet Vanguard DCM CR Tibial Bearing, 14MM x 79/83MM, CR STD bearing, sterile, Biomet... | Zimmer GmbH | JWH | ||
| Z-1375-2008 | Biomet Vanguard DCM CR Tibial Bearing, 18MM x 71/75MM, CR STD bearing, sterile, Biomet... | Zimmer GmbH | JWH | ||
| Z-1318-2008 | Biomet Orthopedics Echo Hip Instrumentation Exact Slotted Stem Inserter, Part number... | Zimmer GmbH | LXH | ||
| Z-1361-2008 | Biomet Vanguard Width Checker, Part Number: 32-487062, 67.5/75 Sizing Wing, Biomet... | Zimmer GmbH | HWT | ||
| Z-2111-2009 | I-Flow Corporation Easy Pump LT 60-24 (60 ml x 2 ml/hr), REF: 04434366, assembled in... | Halyard Health | MEB | ||
| Z-1542-2008 | Altaire MRI System Emergency Rundown Switch Unit (ERDU) is intended to provide the... | FUJIFILM Healthcare Americas Corporation | LNH | ||
| Z-1182-2008 | System 83 Plus Washer-Disinfector, Endoscope use, DOS based system, Custom Ultrasonics... | Wassenburg Medical B.V. | KOG | ||
| Z-1371-2008 | Exacta-Mix 600 Pharmacy Compounding System is used in the pharmacy to compound multiple... | Baxter Corporation Englewood | NEP | ||
| Z-1370-2008 | Exacta-Mix 2400, Pharmacy Compounding System is used in the pharmacy to compound multiple... | Baxter Corporation Englewood | NEP | ||
| Z-2202-2008 | MEDTOXscan Reader | MEDTOX Diagnostics, Inc. | DKZ | ||
| Z-1751-2008 | Siemens Medical Solutions, syngo Dynamics 6.0 Workplace; Picture archiving and... | Siemens Medical Solutions USA, Inc. | LLZ | ||
| Z-2330-2008 | Propper short gas-chex EO sterilization indicators, 250 strips per box, Reorder No... | Propper Mfg Co Inc | JOJ | ||
| Z-0995-2009 | Cyberonics VNS Therapy Demipulse Duo Generator, Model 104; an implantable... | LivaNova USA, Inc. | LYJ |