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-0214-2007 | Lone Star Medical Products, Inc. 1100 Series Aluminum Retractor Rings, model #1110... | Lone Star Medical Products | GAD | ||
| Z-0213-2007 | Lone Star Medical Products, Inc. 1100 Series Aluminum Retractor Rings, Model #1107... | Lone Star Medical Products | GAD | ||
| Z-0212-2007 | Lone Star Medical Products, Inc. 1100 Series Aluminum Retractor Rings, Model #1104... | Lone Star Medical Products | GAD | ||
| Z-0270-05 | Magnetic Resonance Imaging Systems under the following names: Visart Excelart Excelart... | Canon Medical Systems USA, Inc. | LNH | ||
| Z-0277-05 | OTC Pregnancy Tests. Name: Sure Check hCG Cassette Pregnancy Test. --- Description: the... | Chembio Diagnostic Systems, Inc. | LCX | ||
| Z-0276-05 | OTC Pregnancy Tests. Name: Sure Check hCG Midstream Pregnancy Test --- Description: the... | Chembio Diagnostic Systems, Inc. | LCX | ||
| Z-0060-05 | Sterile Multi-Purpose Solution, NO RUB, for soft hydrophylic contact lenses. 12 fl oz... | K C Pharmaceuticals Inc | LPN | ||
| Z-0029-05 | EP Healing Abutment- An abutment device is a premanufactured prosthetic component... | ZimVie US Corp LLC | DZE | ||
| Z-0787-05 | VersaRad Generator | Fischer Imaging Corp. | IYB | ||
| Z-0055-05 | Genital Protector Shield used with Fuji Computed Radiography (FCR) system models 5501D... | FUJIFILM Healthcare Americas Corporation | MQB | ||
| Z-0037-05 | NOVAPLUS Electrosurgical Grounding Pads, Split with Cord Catalog No. 7179V | 3M Company | JOS | ||
| Z-0706-2007 | CELL-DYN 3200 Diluent/Sheath Reagent, List Number 03H79-01,Distributed and Manufactured... | Abbott Medical | GIF | ||
| Z-0025-05 | Difco (TM) BBL (TM) Gram Crystal Violet, 250 mL bottles in packs of four, catalog #... | Becton Dickinson & Co | JTS | ||
| Z-0163-05 | LEONARDO MM-WS, Computed Tomography X-Ray, Model Number 71 29 534 | Siemens Medical Solutions USA, Inc. | JAK | ||
| Z-0162-05 | SOMATOM CT System Sensation 10, Computed Tomography X-Ray System, Model Number 75 43 015 | Siemens Medical Solutions USA, Inc. | JAK | ||
| Z-0161-05 | SOMATOM CT System Sensation Cardiac (+ Straton), Computed Tomography X-Ray System, Model... | Siemens Medical Solutions USA, Inc. | JAK | ||
| Z-0160-05 | SOMATOM CT System Sensation Cardiac, Computed Tomography X-Ray, Model Number 75 43 106 | Siemens Medical Solutions USA, Inc. | JAK | ||
| Z-0159-05 | SOMATOM CT System Sensation 16 (+ Straton), Computed Tomography System, Model Number 73... | Siemens Medical Solutions USA, Inc. | JAK | ||
| Z-0158-05 | SOMATOM CT System Sensation 16, Computed Tomography X-Ray, Model Number 73 93 114 | Siemens Medical Solutions USA, Inc. | JAK | ||
| Z-0157-05 | SOMATOM CT System Emotion 6, Computed Tomography X-Ray System, Model Number: 38 15 490 | Siemens Medical Solutions USA, Inc. | JAK | ||
| Z-0156-05 | SOMATOM CT System Emotion Duo, X-Ray, Tomography, Computed System, Model number 38 13 933 | Siemens Medical Solutions USA, Inc. | JAK | ||
| Z-0211-05 | IR 1200 Insulin Pump. IPX8 Rx only. Label P/N 400-125-00 Revision C. | Animas Corp. | LZG | ||
| Z-0046-05 | Advanced Bionics implantable cochlear stimulator HiRes 90, Models CI-1400-01 CI-1400-02 | Advanced Bionics LLC | MCM | ||
| Z-0045-05 | Advanced Bionics implantable cochlear stimulator CLARION... | Advanced Bionics LLC | MCM | ||
| Z-0044-05 | Advanced Bionics implantable cochlear stimulator CLARION 1.2 Models... | Advanced Bionics LLC | MCM | ||
| Z-0028-05 | SOLO-care Plus with Aqualube, Multi-purpose solution*** AquaSoft (Private label)... | Alcon Laboratories | LPN | ||
| Z-0024-05 | Remel Chocolate Agar, catalog #01301, containing 15 plates/pkg, for in-vitro diagnostic... | Remel Inc | KZI | ||
| Z-0059-05 | Arrowg+ard Blue Two Lumen CVC Super Kit, Catalog number AK-22802-SK. The kit actually... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | ||
| Z-0412-2007 | Thoratec Dual Drive Console a drive component of the Thoratec Ventricular Assist Device... | Abbott Medical | DSQ | ||
| Z-0877-05 | Sabina I and II EM/EE Patient Lift | Liko, Inc. | FNG | ||
| Z-0876-05 | UNO 100 EM/EE Patient Lift | Liko, Inc. | FNG | ||
| Z-0875-05 | UNO 102 EM/EE/ES Patient Lift | Liko, Inc. | FNG | ||
| Z-0807-05 | Programming software (all versions) for Polymedco PolyTiter Immunofluorescent Titration... | Diasorin Inc. | DHN | ||
| Z-0496-05 | Proven Porous CR Femur. Implantable orthopedic device | Globus Medical, Inc. | JWH | ||
| Z-0018-05 | Trio Monitor. Cardiac Monitor (including cardiotachometer and rate alarm). | Datascope Corp. | NWI | ||
| Z-0016-05 | AEROSET Analyzer, Systems Operation Manual. | Abbott Medical | JJE | ||
| Z-0419-05 | Bosworth TruRepair Fast Bonding Repair Acrylic; the box contains one 8 oz. bottle of... | Harry J. Bosworth Co. | EDI | ||
| Z-0197-05 | Tosoh brand AIA-PACK CA 19-9 Test Cup Set used in TOSOH AIA Immunoassay Analyzers, A pack... | Tosoh Bioscience Inc | NIG | ||
| Z-0196-05 | POLYSTAR T.O.P., Angiographic X-Ray System, Model Numbers 1148902 and 4784505. | Siemens Medical Solutions USA, Inc. | IZI | ||
| Z-0195-05 | POLYSTAR, Angiographic X-Ray System, Model 1148902 | Siemens Medical Solutions USA, Inc. | IZI | ||
| Z-0110-06 | The Lysus Infusion System - Catheter Interface Cable. The Lysus Infusion System employs... | EKOS Corporation | KRA | ||
| Z-0038-05 | V.A.C. X-Large Granufoam Dressing Part Numbers M6275065/5, V.A.C. ATS and V.A.C. Freedom... | KCI USA, Inc. | JCX | ||
| Z-0062-05 | Infusion Dynamics Power Infuser pump. Model number M100B-3A | Infusion Dynamics, A Div. of Zoll Med Corpinfusion Dynamics | FRN | ||
| Z-0552-05 | Arrow PICC Two Lumen Peripherally Inserted Central Catheter Set with Blue FlexTip... | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJS | ||
| Z-0551-05 | Arrow PICC Kit with Blue Flex Tip Catheter and Placement Wire. Catalog number... | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJS | ||
| Z-0256-05 | LifePort, Dual Lumen Profile Plastic Dual Port with Poly Urethane Catheter Kit, Product... | Boston Scientific Corporation | LJT | ||
| Z-0017-05 | Fresenius Peritoneal Dialysis Premier Luer Lock Transfer Set 8'', Sterile with Female... | Fresenius Medical Care Renal Therapies Group, LLC | KDJ | ||
| Z-0210-05 | Deltec Cozmo Insulin Pump | Abbott Medical | LZG | ||
| Z-0456-05 | BacT/ALERT(BTA) Classic instruments. | bioMerieux, Inc. | MDB | ||
| Z-0009-05 | Applied Blunt Tip Trocar Models C0717 and C0718 | Applied Medical Resources Corp | KXN |