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-2335-2018 | Class II | Merlin PCS Programmer Software: 3330 The Merlin PCS programmer (model 3650) is a... | Abbott Medical | MXC | |
| Z-2334-2018 | Class II | St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The... | Abbott Medical | MXC | |
| Z-2329-2018 | Class II | Merlin PCS programmer (Model # 3650), Software (Model # 3330) | Abbott Medical | OSR | |
| Z-2328-2018 | Class II | Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435... | Abbott Medical | NIK | |
| Z-2327-2018 | Class II | Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944... | Abbott Medical | NIK | |
| Z-2326-2018 | Class II | Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904... | Abbott Medical | NIK | |
| Z-2325-2018 | Class II | Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177... | Abbott Medical | NIK | |
| Z-2324-2018 | Class II | Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335... | Abbott Medical | NIK | |
| Z-2323-2018 | Class II | Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195... | Abbott Medical | LWS | |
| Z-2322-2018 | Class II | Promote, Sterile EO, Model #/ Part #: 3207-30/60010740-207, 60010740-407... | Abbott Medical | LWS | |
| Z-2321-2018 | Class II | Fortify Assura, Sterile EO, Model #/ Part #: CD1257-40/100042322, 100059623... | Abbott Medical | LWS | |
| Z-2320-2018 | Class II | Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981... | Abbott Medical | LWS | |
| Z-2319-2018 | Class II | Ellipse, Sterile EO, Model #/ Part #: CD1275-36/100116115... | Abbott Medical | LWS | |
| Z-2318-2018 | Class II | Current, Sterile EO, Model #/ Part #: 1207-30/50020236-001, 60010739-207... | Abbott Medical | LWS | |
| Z-1803-2018 | Class II | BARD PERIPHERAL VASCULAR SEEKER(R) Crossing Support Catheter, 0.014", 150 cm, REF... | Bard Peripheral Vascular Inc | DQY | |
| Z-1802-2018 | Class II | BARD PERIPHERAL VASCULAR SEEKER(R) Crossing Support Catheter, 0.035", 150 cm, REF... | Bard Peripheral Vascular Inc | DQY | |
| Z-1912-2018 | Class II | AMENDIA Omega Lumbar Interbody Fusion Device, Part Number 72-00-2-092812-11 The... | Spinal Elements, Inc | MAX | |
| Z-1521-2018 | Class II | Advance 35LP Low-Profile PTA Balloon Dilatation Catheter; Catalog numbers... | Cook Incorporated | DQY | |
| Z-1704-2018 | Class II | ATTUNE Revision CRS Femoral RT SZ 5 Cemented, Catalog No. 150440205, Femoral Revision... | Depuy Orthopaedics Inc. | JWH | |
| Z-1703-2018 | Class II | ATTUNE Revision CRS Femoral LT SZ 5 Cemented, Catalog No. 150440105, Femoral Revision... | Depuy Orthopaedics Inc. | JWH | |
| Z-0808-2020 | Class II | Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac... | Abbott Medical | MXC | |
| Z-1768-2019 | Class I | Alaris Pump, Model 8100, with bezel mechanical assemblies manufactured with FR-110... | CareFusion 303, Inc | FRN | |
| Z-3021-2018 | Class II | CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number... | Cardiovascular Systems Incorporated | MCX | |
| Z-2662-2018 | Class II | Medfusion Syringe Infusion Pump, containing the Barrel Clamp Guide mechanism | Abbott Medical | FRN | |
| Z-2265-2018 | Class II | Nitinol Staple, Elastic Staple Small-Symmetrical, Sterile R, Model #: a) ES-08x08; b)... | Trimed Inc | JDR | |
| Z-2264-2018 | Class II | Nitinol Staple, Elastic Staple Small-Asymmetrical, Sterile R, Model #: a) ES-10x13x15; b)... | Trimed Inc | JDR | |
| Z-2263-2018 | Class II | Nitinol Staple, Elastic Staple Large-Symmetrical, Sterile R, Model #: a) ES-18x14; b)... | Trimed Inc | JDR | |
| Z-2262-2018 | Class II | Nitinol Staple, Elastic Staple Large-Asymmetrical, Sterile R, Model #: a) ES-18x15x17; b)... | Trimed Inc | JDR | |
| Z-1883-2018 | Class II | Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack (Carbide Burs), Model R100702 a... | Coltene /Whaledent AG | EJL | |
| Z-2739-2018 | Class II | VitalGo Total Lift Bed VG-TLB425T-TQR, Version 71064V0-27003 | Vitalgo Inc. | FNL | |
| Z-2569-2018 | Class II | FlowGate2 Balloon Guide Catheter, UPN 90485 (8Fx85cm size) and 90495 (8Fx95cm size) | Stryker Corp. | DQY | |
| Z-2032-2018 | Class II | 9 Fr. Radiopaque Polyurethane Sheath/Dilator with Integral Hemostasis Valve/Side Port for... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DYB | |
| Z-2031-2018 | Class II | ARROWg+ard Blue PSI Kit with Integral Hemostasis Valve/ Side Port for use with 7 - 7.5... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DYB | |
| Z-2030-2018 | Class II | Extension Line Slide Clamps; Product codes: SA-09847 | Arrow International LLC (subsidiary of Teleflex Incorporated) | KGZ | |
| Z-2029-2018 | Class II | Sheath Adapter with Cath-Gard Catheter Contamination Shield for use with 4 - 7 Fr... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DYB | |
| Z-2028-2018 | Class II | VPS TipTracker Stylet Accessory; Product codes: RHY-177-TTSAP | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJS | |
| Z-2027-2018 | Class II | VPS Rhythm ECG Accessory Pack ; Product codes: RHY-100-ECGO | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJS | |
| Z-2026-2018 | Class II | VPS Rhythm ECG Accessory Pack with Johans Adapter; Product codes: RHY-100-ECGJ | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJS | |
| Z-2025-2018 | Class II | Arrow PICC with Chlorag+ard Technology; Product codes: PR-44041-BAS, PR-44052-BAS... | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJS | |
| Z-2024-2018 | Class II | ARROW PICC Set; Product codes: PR-35563-HPHNL and PR-35563-HPHNM | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJS | |
| Z-2023-2018 | Class II | ARROW PICC Set; Product codes: PR-34052-HPHNM, PR-34063-HPHNM, PR-35041-HPHNM... | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJS | |
| Z-2022-2018 | Class II | Echogenic Needle; Product codes: PN-00215-E and PN-00217-E | Arrow International LLC (subsidiary of Teleflex Incorporated) | FMI | |
| Z-2021-2018 | Class II | Peel Away Sheath over Dilator; Product Codes: PL-05041 and PL-05052 | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJS | |
| Z-2020-2018 | Class II | PICC Catheter Trimmer ; Product Code:PC-00001-T | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJS | |
| Z-2019-2018 | Class II | Arterial Catheterization Kit; Product Code:NA-04550-1A | Arrow International LLC (subsidiary of Teleflex Incorporated) | DQX | |
| Z-2018-2018 | Class II | ARROWgard Blue PLUS Multi-Lumen CVC Kit with Blue FlexTip Catheter; Product Code... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DYB | |
| Z-2017-2018 | Class II | Percutaneous Sheath Introducer Kit with ARROWgard Blue Sheath and Integral Hemostasis... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DYB | |
| Z-2016-2018 | Class II | 10 cc Luer-Slip Loss of Resistance Syringe; Product Code: LR-05501 | Arrow International LLC (subsidiary of Teleflex Incorporated) | FMF | |
| Z-2015-2018 | Class II | ARROW JACC with Chlorag+ard Technology; Product Code: JR-42063-HPHNM and JR-42563-HPHNM | Arrow International LLC (subsidiary of Teleflex Incorporated) | OBJ | |
| Z-2014-2018 | Class II | Arrow-Johans" ECG Adapter for Right Atrial Electrocadiography (RAECG); Product Code... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DQY |