Browse Device Recalls
3,013 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,013 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 3,013 FDA device recalls in 2018.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 13, 2018 | Nitinol Staple, Elastic Staple Large-Asymmetrical, Sterile R, Model #: a) ES-... | During a retrospective review of sterilization records, TriMed has determined that evidence of qu... | Class II | TriMed Inc. |
| Apr 13, 2018 | Alaris Pump, Model 8100, with bezel mechanical assemblies manufactured with F... | The bezel manufacturing process for the FR-110 plastic may have resulted in its weakening. A bez... | Class I | CareFusion 303, Inc. |
| Apr 13, 2018 | CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Nu... | The pumps may switch to stand-by during use requiring the pump to be reset prior to continuing tr... | Class II | Cardiovascular Systems Inc |
| Apr 13, 2018 | Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Ca... | Devices inappropriately displayed a low battery indicator determined to be due to memory corruption. | Class II | St Jude Medical, Cardiac Rhythm Management Divi... |
| Apr 13, 2018 | Nitinol Staple, Elastic Staple Large-Symmetrical, Sterile R, Model #: a) ES-1... | During a retrospective review of sterilization records, TriMed has determined that evidence of qu... | Class II | TriMed Inc. |
| Apr 13, 2018 | Nitinol Staple, Elastic Staple Small-Asymmetrical, Sterile R, Model #: a) ES-... | During a retrospective review of sterilization records, TriMed has determined that evidence of qu... | Class II | TriMed Inc. |
| Apr 13, 2018 | Medfusion Syringe Infusion Pump, containing the Barrel Clamp Guide mechanism | Certain Barrel Clamp Guides may contain a ridge that could potentially lead to spring slippage, r... | Class II | Smiths Medical ASD Inc. |
| Apr 12, 2018 | VitalGo Total Lift Bed VG-TLB425T-TQR, Version 71064V0-27003 | Potential for unintentional movement of the support surface of the bed from tilted position to ho... | Class II | Vitalgo Inc. |
| Apr 11, 2018 | NvisionVLE¿ Low-Profile Optical Probe; Catalog Numbers: 95501-LP and 95501-LP... | Distal tips of the probes may detach from the probe shaft during use. | Class II | Ninepoint Medical Inc. |
| Apr 11, 2018 | Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+a... | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | Radial Artery Catheterization Kit with Sharps Safety Features; Product Codes:... | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | Spring-Wire Guide Introducer Catheter Assembly; Product Code: CN-04018 | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | Pressure Injectable Multi-Lumen Central Venous Catheterization Kit; Product C... | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | Maximal Barrier Drape; Product Code: ASK-01000-UPMS | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | Pressure Injectable Two-Lumen Central Venous Catheterization Kit with Blue Fl... | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | Arterial Line Kit with Sharps Safety Features and Maximal Barrier Precautions... | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | Pressure Injectable Quad-Lumen Central Venous Catheterization Kit with Blue F... | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | 10 cc Luer-Slip Loss of Resistance Syringe; Product Code: LR-05501 | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | SnapLock" Catheter/Syringe Adapter; Product Code: AS-05500 | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit; Produ... | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue ... | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | Continuous Nerve Block Needle; Product Codes: AB-00090, AB-00150, AB-17040-N... | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue ... | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue ... | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | ARROWg+ard Blue(R) Central Venous Catheterization Kit; Product Code: ASK-2430... | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | VPS TipTracker Stylet Accessory; Product codes: RHY-177-TTSAP | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | Spring Wire Guide Introducer Needle; Product Codes: AN-04320 and AN-04418 | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | Echogenic Needle; Product codes: PN-00215-E and PN-00217-E | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | Double-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+... | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | The BD Vacutainer Plus Plastic Citrate Blood Collection Tube is an evacuated ... | Approximately 3.4% of BD Vacutainer Plus Plastic Citrate Blood Collection Tubes (2.7mL) (light bl... | Class II | Becton Dickinson & Company |
| Apr 11, 2018 | Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+a... | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | Maximal Barrier Drape; Product Codes: ASK-00376-SU | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | Pressure Injectable Multi-Lumen Central Venous Catheterization Kit; Product C... | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | Arrow-Johans" ECG Adapter for Right Atrial Electrocadiography (RAECG); Produc... | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | 0.2 Micron Flat Epidural Filter; Product Code: EF-05500 | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | 9 Fr. Radiopaque Polyurethane Sheath/Dilator with Integral Hemostasis Valve... | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | ARROWgard Blue PLUS¿ Multi-Lumen CVC Kit with Blue FlexTip¿ Catheter; Product... | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | Catheter Hemostasis Valve For use with .038" (.096 cm) dia. and smaller guide... | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | Arrow PICC with Chlorag+ard Technology; Product codes: PR-44041-BAS, PR-4405... | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | ARROW PICC Set; Product codes: PR-35563-HPHNL and PR-35563-HPHNM | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+a... | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | Clear Fenestrated Drape with Adhesive; Product Code: CD-00001 | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | ARROWg+ard Blue¿ PSI Kit with Integral Hemostasis Valve/ Side Port for use wi... | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | Echogenic Introducer Needle; Product Code: AN-04318 | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter an... | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+a... | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | ARROWg+ard Blue PLUS¿ Pressure Injectable Two-Lumen CVC Kit; Product Code: CD... | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | Arterial Catheterization Kit; Product Codes: ASK-04020-DH | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | Sheath Adapter with Cath-Gard¿ Catheter Contamination Shield for use with 4 -... | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath, Integral H... | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types, from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.