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 11, 2018 | MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue(R) Access De... | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | Percutaneous Sheath Introducer Kit with ARROWgard Blue¿ Sheath and Integral ... | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7... | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | ARROW JACC with Chlorag+ard Technology; Product Code: JR-42063-HPHNM and JR-4... | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | 5Fr. Catheter Clamp with Fastener; Product Code: CC-00005 | 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 | Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter... | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | Maximal Barrier Drape; Product Codes: ASK-00002-1A | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | 7Fr. Catheter Clamp with Fastener; Product Code: CC-00007 | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | TheraCath(R) Epidural Catheter; Product Code: EC-05000 | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | VPS Rhythm ECG Accessory Pack ; Product codes: RHY-100-ECGO | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | ARROW PICC Set; Product codes: PR-34052-HPHNM, PR-34063-HPHNM, PR-35041-HPHNM... | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | PICC Catheter Trimmer ; Product Code:PC-00001-T | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port f... | 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 | ARROWgard Blue PLUS Triple-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 | Radial Artery Catheterization Kit; Product Codes: ASK-04020-AH, ASK-04020-MIH... | 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 | Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard... | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | Extension Line Slide Clamps; Product codes: SA-09847 | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | Arterial Catheterization Kit; Product Code:NA-04550-1A | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | Pressure Injectable ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheter... | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | Radial Arterial Access Kit; Product Code: ASK-04001-BID2 | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | VPS Rhythm ECG Accessory Pack with Johans Adapter; Product codes: RHY-100-ECGJ | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | Epidural Needle; Product Codes: AN-05501 and AN-05505 | 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 Multi-Lumen CVC Kit; Product Codes:... | 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 | Maximal Barrier Drape; Product Codes: ASK-00001-1A | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | Peel Away Sheath over Dilator; Product Codes: PL-05041 and PL-05052 | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port a... | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | ARROWg+ard Blue PLUS¿ Pressure Injectable Quad-Lumen CVC Kit; Product Codes: ... | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | Arrow-Flex(R) Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Shea... | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | Pressure Injectable ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Cathet... | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | Maximal Barrier Drape; Product Code: ASK-04000-HMC | 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 | 8Fr. Catheter Clamp with Fastener; Product Code: CC-00008 | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | 4Fr. Catheter Clamp with Fastener; Product Code: CC-00004 | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | FlowGate2 Balloon Guide Catheter, UPN 90485 (8Fx85cm size) and 90495 (8Fx95cm... | There may be product manufactured with the outer diameter of the balloon catheter exceeding the d... | Class II | Stryker Neurovascular |
| Apr 10, 2018 | CyberKnife VSI, Part Numbers: a) 032500-010: CyberKnife VSI 9.6.x Robotic R... | There is an unintended drop of a secondary collimator housing that can occur during housing Xchan... | Class II | Accuray Incorporated |
| Apr 10, 2018 | CyberKnife M6, Part Numbers: a) 0660000: CyberKnife Treatment Delivery Syste... | There is an unintended drop of a secondary collimator housing that can occur during housing Xchan... | Class II | Accuray Incorporated |
| Apr 10, 2018 | BARD¿ BrachySource¿ Iodine125 radioactive seeds consist of a welded titanium ... | Bard Medical Division is recalling the BARD¿ BrachySource¿ Iodine125 Radioactive Seeds in Mick¿ A... | Class II | Bard Brachytherapy, Inc. |
| Apr 9, 2018 | smith&nephew 5o (5 degree) GENESIS(R) II VALGUS BUSHING, REF CATALOG NUMBER 7... | A single lot of GENESIS II FEMORAL FIVE DEGREE VALGUS BUSHING due to a laser mark labeling error.... | Class II | Smith & Nephew, Inc. |
| Apr 9, 2018 | Angio-Seal Evolution Vascular Closure Device, Cat. No. C610135 | Two lots of product were released for distribution prior to the completion of all required valida... | Class II | Terumo Medical Corp |
| Apr 9, 2018 | VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument kit | IFU contained an automated cleaning process for the VerteLP Instrument Tray that was not validated | Class II | VGI Medical, LLC |
| Apr 9, 2018 | EEA" Hemorrhoid and Prolapse Stapler Set with DST Series" Technology 4.8MM, P... | There is a potential for improper welding of the yellow staple guide to the instrument. Use of a ... | Class II | Covidien LLC |
| Apr 9, 2018 | HLD Systems 600 Series Washer/Pasteurizer, UDI (01) 0085249007009 (11) 160929... | There is a supplier quality issue with the terminal blocks which may cause the terminal block to ... | Class II | Cenorin, LLC |
| Apr 9, 2018 | EEA" Hemorrhoid and Prolapse Stapler Set with DST Series" Technology 3.5MM, P... | There is a potential for improper welding of the yellow staple guide to the instrument. Use of a ... | Class II | Covidien LLC |
| Apr 9, 2018 | VIDAS FSH, Ref 30407-01, IVD, Rx. The firm name on the label is bioMerieux S... | Invalid calibration with low calibrator S1 while using the product. | Class II | BioMerieux SA |
| Apr 7, 2018 | DriSate¿ Product Code DR-145 The acid concentrate powders and liquids are ... | A subassembly component (dextrose bag) within this case product contained small amounts of sodium... | Class II | Rockwell Medical, 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.