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-0307-06 | Isulin Pump. Model IR1000 | Animas Corp. | LZG | ||
| Z-0306-06 | Isulin Pump. Models R1000 | Animas Corp. | LZG | ||
| Z-0179-06 | FHC microTargeting Power Assist System used with the micro Targeting Drive System... | FHC, Inc. | HAW | ||
| Z-0270-06 | Fusion OMNI- GT * DOME TIP: ERCP Catheter: 6.0 FR./200 CM. 8 Minimum Accessory Channel... | Wilson-Cook Medical Inc. | FGY | ||
| Z-1375-05 | Newport HT50 All Purpose Ventilator | Newport Medical Instruments, Inc. | CBK | ||
| Z-0344-06 | Implantable Chest Ports labeled: Titanium Single Lumen Port with PASV Valve and 6.6F... | Boston Scientific Corporation | LJS | ||
| Z-0343-06 | Implantable Chest Ports labeled: Titanium Single Lumen Port with PASV valve and 6.6F... | Boston Scientific Corporation | LJS | ||
| Z-0342-06 | Silicone Central Venous Catheters with PASV Valve and Polyester Cuff - 7F. Boston... | Boston Scientific Corporation | LJS | ||
| Z-0341-06 | Silicone Central Venous Catheter with PASV Valve and Polyester Cuff - 6.6F. Boston... | Boston Scientific Corporation | LJS | ||
| Z-0340-06 | Vaxcel Implantable Vascular Access System - Titanium Mini Port with 7F Polyurethane... | Boston Scientific Corporation | LJS | ||
| Z-0416-06 | Vysis LSI p16 (9p21)/CEP 9 (9p11-q11) Dual Color Probe Set; a locus specific identifier... | Abbott Molecular, Inc. | MAO | ||
| Z-0446-06 | Depuy Mitek Fastin RC Anchor with Panacryl (2) strands Size 2 Panacryl Poly ***braided... | DePuy Mitek, Inc. | MAI | ||
| Z-0550-06 | AP II Pain Management System infusion pump, product codes 2L3105, 2L3105K, 2L3105R... | Baxter Healthcare Corporation | MEA | ||
| Z-0549-06 | Baxter I-Pump Pain Management System infusion pump, product codes 2L3107, 2L3107K and... | Baxter Healthcare Corporation | MEA | ||
| Z-0713-06 | SonoCalc IMT 3.0, a windows based software used in conjunction with images from... | FUJIFILM SonoSite,Inc. | LLZ | ||
| Z-0408-06 | STA Liatest Free Protein S, cat. 00516. These kits are intended for use with analyzers... | Diagnostica Stago, Inc. | GGP | ||
| Z-0267-06 | ELA Rhapsody SR model 2210. A single chamber rate-responsive pacemaker that uses both... | Ela Medical, Inc. | DXY | ||
| Z-0266-06 | Symphony DR model 2550 and ELA Rhapsody DR model 2510. A dual chamber rate-responsive... | Ela Medical, Inc. | DXY | ||
| Z-0264-06 | Precision Tack Transvaginal Sling Kit with Non-Absorbable, Braided Polyester Suture... | Boston Scientific Corporation | GAD | ||
| Z-0263-06 | Precision Tack Transvaginal Sling Kit with Non-Absorbable, Polybustester Monofilament... | Boston Scientific Corporation | GAD | ||
| Z-0262-06 | Capio CL Kit Transvaginal Suture Capturing Device (1TLC Retractor box ) Product Code... | Boston Scientific Corporation | GAD | ||
| Z-0261-06 | Precision Tack Transvaginal Sling Kit with Non-Absorbable, Braided Polyester Suture... | Boston Scientific Corporation | GAD | ||
| Z-0260-06 | Precision Twist Transvaginal Sling Kit with Non-Absorbable, Polybutester Monofilament... | Boston Scientific Corporation | GAD | ||
| Z-0259-06 | TLC Retractor and Single Step Pelvic Drape (contains 1 Product Code 820-175) Product... | Boston Scientific Corporation | GAD | ||
| Z-0258-06 | TLC Self -Retaining Retractor System-5/box Product Number:820-176 | Boston Scientific Corporation | GAD | ||
| Z-0257-06 | TLC Self -Retaining Retractor System-Single Product Code: 820-175 | Boston Scientific Corporation | GAD | ||
| Z-0405-06 | BD 1 mL Allergist tray with 26G x 3/8 in. BD Safety Glide. | Becton Dickinson & Co | MEG | ||
| Z-0404-06 | BD 1 mL Allergist tray with 27 G x 1/2 in. BD Safety Glide. | Becton Dickinson & Co | FMF | ||
| Z-0403-06 | BD 1 mL BD Safety Glide Tuberculin syringe with 26 G x 3/8 in. BD needle. | Becton Dickinson & Co | MEG | ||
| Z-0402-06 | BD 1 mL BD Safety Glide tuberculin syringe with 27 G x 1/2 in. BD needle. | Becton Dickinson & Co | FMF | ||
| Z-0466-06 | Omron brand 3-Way Instant Thermometer, Model Numbers MC-600 (USA) and MC-600CAN... | Omron Healthcare Co., Ltd. | FLL | ||
| Z-0391-06 | Cook brand Zilver 635 Biliary Stent - Expanding Stent, delivery system length 80 cm... | Cook Incorporated | FGE | ||
| Z-0390-06 | Cook brand Zilver 635 Biliary Stent - Expanding Stent, delivery system length 80 cm... | Cook Incorporated | FGE | ||
| Z-0706-06 | Gambro Prisma HF1000 preset, Part No. 8399050. | Gambro Renal Products | KDI | ||
| Z-0705-06 | Gambro Prisma M100 preset, Part No. 8353486. | Gambro Renal Products | KDI | ||
| Z-0388-06 | Elation, Class I Medical Device Prosthetic product, Component, External, Limb, Ankle/Foot... | Ossur Iceland ehf. | ISH | ||
| Z-0328-06 | Detachable T-handle (Orthopedic Manual Surgical Instrumentation) Catalog Number... | Encore Medical, LP | LXH | ||
| Z-0291-06 | Viceroy Inflation Syringe, 60mL, without gauge. | Merit Medical Systems, Inc. | MAV | ||
| Z-0290-06 | Viceroy Inflation Syringe, 60mL, Sterile, Rx only. | Merit Medical Systems, Inc. | MAV | ||
| Z-0274-06 | KODAK DirectView DR 7100 System, Catalog # 133-6049. This is a digital radiology system... | Eastman Kodak Company | KPR | ||
| Z-1287-06 | Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power... | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-1286-06 | Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A... | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-0181-06 | Terumo Sarns brand Soft-Flow Aortic Cannula with flange, angled, wire-reinforced, with... | Terumo Cardiovascular Systems Corporation | DWF | ||
| Z-0273-06 | LifeScan brand OneTouch Ultra Test strips, 25 strips per vial | Lifescan, Inc. | NBW | ||
| Z-0151-06 | The Applied GelPort Hand Access Device consists of a GelSeal Cap, Wound retractor (base)... | Applied Medical Resources Corp | GCJ | ||
| Z-0400-06 | ARCHITECT STAT Myoglobin Calibrators; list 02K43-01; each kit contains 6 bottles of... | Abbott Medical | DDR | ||
| Z-0703-06 | Osteofil RT, ICM Allograft Paste in varying sizes. Product is labeled in part... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | MQV | ||
| Z-0702-06 | Osteofil ICM Moldable Strip of varying sizes. Product is labeled in part... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | MQV | ||
| Z-0701-06 | Osteofil IC Syringeable of varying sizes. Product is labeled in part: ''***Processed... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | MQV | ||
| Z-0700-06 | Osteofil Allograft Paste (Bio) of varying sizes. Product is labeled in part... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | MQV |