Browse Device Recalls
478 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 478 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 478 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 2, 2018 | AF w/AS 550 x 1-14ML/HR 5ML-60LO CPNB, Product code MVBX60XL CPNB, Arrow Auto... | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak i... | Class II | Arrow International Inc |
| Oct 2, 2018 | AF w/AS 550 x 1-14ML/HR 2ML-15LO CPNB, Product code MVBT15XL-CPNB, Arrow Auto... | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak i... | Class II | Arrow International Inc |
| Oct 2, 2018 | AF w/AS 550 x 1-14ML/HR 2ML-30LO CPNB, Product code MVBT30XL CPNB, Arrow Auto... | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak i... | Class II | Arrow International Inc |
| Oct 2, 2018 | AF 550 x 5ML/H 6" DUAL CATHS, 4.5", Product code MC0050XLYK5 CP, Arrow AutoFu... | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak i... | Class II | Arrow International Inc |
| Oct 2, 2018 | AF 550 x 5ML/H 6" CATH, 4.5" IN, Product code MC0050XLSK5 CP, Arrow AutoFuser... | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak i... | Class II | Arrow International Inc |
| Oct 2, 2018 | AF w/AS 550 x 1-14 ml/hr, 5ml30 LOCPNB, Product code MVBX30XLCPNB, Arrow Auto... | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak i... | Class II | Arrow International Inc |
| Oct 2, 2018 | AF w/AS 550 x 1-14ML/HR CPNB, Product code MVBXL- CPNB, Arrow AutoFuser Dispo... | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak i... | Class II | Arrow International Inc |
| Sep 21, 2018 | Arrow AGB+ Multi-Lumen CVC Kit, 7 Fr., 3 Lumen, 20cm catheter length, .025 in... | The products labeling contains inconsistencies. In certain instances, the lidstock, banner card ... | Class II | Arrow International Inc |
| Aug 30, 2018 | Arrow AGB + Multi-Lumen CVC Kit, Cat. No. CDC-42703-B1A. Product Usage - The ... | The product was shipped after its expiry date due to a system error. The product lidstock identi... | Class II | Arrow International Inc |
| Jul 30, 2018 | ARROW¿ Bipolar Electrode Catheter with shrouded pins , 6 Fr, 110 cm Product ... | Products are labeled with an incorrect expiration date | Class II | Arrow International Inc |
| Jul 17, 2018 | 5.5 Fr x 40 cm double-lumen PICC Kit, Product Code CDC-44052-VPS2 | The products may contain the incorrect catheter. Kits that should contain a 4.5 Fr single-lumen c... | Class II | Arrow International Inc |
| Jul 17, 2018 | 4.5 Fr x 40 cm single-lumen PICC Kit, Product Code CDC-44041-VPS2, 5.5 Fr dou... | The products may contain the incorrect catheter. Kits that should contain a 4.5 Fr single-lumen c... | Class II | Arrow International Inc |
| Jul 10, 2018 | HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only ... | The packaging may not be sealed. If the packaging is compromised in this manner, the sterility of... | Class II | Arrow International Inc |
| Jul 10, 2018 | HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only ... | The packaging may not be sealed. If the packaging is compromised in this manner, the sterility of... | Class II | Arrow International Inc |
| Jul 3, 2018 | Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip AR... | One lot of product is from product code AK-22502 so it contains a 2-lumen, 5 Fr x 5 cm catheter.... | Class II | Arrow International Inc |
| May 23, 2018 | Percutaneous Sheath Introducer Kit for use with 7 - 7.5 Fr. Catheters (8 Fr.... | Product contains dry natural rubber latex. Label states Latex Free. | Class II | Arrow International Inc |
| May 17, 2018 | VPS Rhythm ECG Accessory Pack with Johans Adapter, REF RHY-100-ECGJ Produc... | Product pouch label may not easily identify the lot number, expiration date and associated symbo... | Class II | Arrow International Inc |
| May 17, 2018 | VPS Rhythm ECG Accessory Pack, REF RHY-100-ECGO Product Usage: To provide... | Product pouch label may not easily identify the lot number, expiration date and associated symbo... | Class II | Arrow International Inc |
| May 17, 2018 | VPS TipTracker Stylet Accessory, REF RHY-177-TTSAP Product Usage: To prov... | Product pouch label may not easily identify the lot number, expiration date and associated symbo... | Class II | Arrow International Inc |
| May 17, 2018 | Peripherally Inserted Midline Catheter Kit with Placement Wire, REF MK-02031-... | Product pouch label may not easily identify the lot number, expiration date and associated symbo... | Class II | Arrow International Inc |
| May 11, 2018 | Multi-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter, CS... | The recalling firm has received complaints related to increased resistance encountered when intro... | Class II | Arrow International 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 |
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.