Browse Device Recalls
3,191 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,191 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 3,191 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 24, 2018 | MEDLINE Sterile* Needle Counter, 100Ct. Double Magnet / Foam Block, reorder: ... | The product packaging seal has the potential to experience seal creep. This may result in gaps to... | Class II | Medline Industries Inc |
| Apr 24, 2018 | MEDLINE Sterile* Needle Counter, 40Ct. Foam Block / Magnet, reorder: DYNJNC40... | The product packaging seal has the potential to experience seal creep. This may result in gaps to... | Class II | Medline Industries Inc |
| Apr 24, 2018 | MEDLINE O.R. Necessities(TM) Sterile* Needle Counter, 40 Ct. Double Magnet / ... | The product packaging seal has the potential to experience seal creep. This may result in gaps to... | Class II | Medline Industries Inc |
| Apr 24, 2018 | MEDLINE O.R. Necessities(TM) Sterile* Needle Counter, 100 Ct. Double Magnet /... | The product packaging seal has the potential to experience seal creep. This may result in gaps to... | Class II | Medline Industries Inc |
| Apr 24, 2018 | MEDLINE O.R. Necessities(R) STERILE R, Needle Counter/Compte-aiguiles/Caja de... | The product packaging seal has the potential to experience seal creep. This may result in gaps to... | Class II | Medline Industries Inc |
| Apr 24, 2018 | MEDLINE Sterile* Needle Counter, 40Ct. Foam Block / Adhesive, reorder: DYNJNC... | The product packaging seal has the potential to experience seal creep. This may result in gaps to... | Class II | Medline Industries Inc |
| Apr 16, 2018 | BARD PERIPHERAL VASCULAR SEEKER(R) Crossing Support Catheter, 0.014", 150 cm,... | Device is at risk of having detectable levels of bacterial endotoxin present on the packaging hoo... | Class II | Bard Peripheral Vascular Inc |
| Apr 16, 2018 | BARD PERIPHERAL VASCULAR SEEKER(R) Crossing Support Catheter, 0.035", 150 cm,... | Device is at risk of having detectable levels of bacterial endotoxin present on the packaging hoo... | Class II | Bard Peripheral Vascular 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 | 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 |
| 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 |
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.