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 16, 2015 | ARROW PICC Kit featuring Chlorag+ard Technology Midline Catheterization Kit ... | Possibility that the catheter peel-away component hub tabs may prematurely detach when the pract... | Class II | Arrow International Inc |
| Sep 18, 2015 | 4FR Single Lumen Pressure Injectable PICC; intravascular therapeutic cathete... | Labeling inaccuracy in the Instructions for Use (IFU) and Patient Card. The IFU and Patient Card... | Class II | Arrow International Inc |
| Aug 27, 2015 | Arrow Kits with Medtronic Covidien 0.9% Sodium Chloride Flush Syringes | Manufacturer of 0.9% Sodium Chloride Flush Syringes recalled due to compromised sterility of the ... | Class II | Arrow International Inc |
| Jul 30, 2015 | PICC Kits with Peel-Away Sheath Component; catheter, intravascular, therapeut... | the catheter peel-away component hub tabs may prematurely detach. One injury reported. | Class II | Arrow International Inc |
| Jul 30, 2015 | Arrow International, Inc. PICC Kits and VPS Access Kits with Touhy Borst Comp... | saline leakage from unsecured connections between the Touhy Borst adaptor and the hub of the cath... | Class II | Arrow International Inc |
| Feb 5, 2015 | ARROW FiberOptix Intra-Aortic Balloon Catheter Kit, 40 cc 7.5 Fr Product Cod... | Outer package product label incorrectly identifies the product as FiberOptix Flex IAB 7.5Fr rat... | Class II | Arrow International Inc |
| Jan 9, 2015 | Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC) and Arterial ... | Certain product codes and lot numbers of Kits with Biopatch Dressing were packaged with the inco... | Class III | Arrow International Inc |
| Jan 5, 2015 | ARROW Epidural Needle Component (product number AN-05501). Epidural needles ... | The product labeling does not specify the 5 year shelf life of the product. | Class II | Arrow International Inc |
| Jan 2, 2015 | ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit. The Multiple-Lume... | Foreign material found within the kits. The foreign material, white or black particles and/or thr... | Class II | Arrow International Inc |
| Dec 16, 2014 | Multi-Lumen PI CVC Kit and PSI Kit: 3-L 7 FR X 8 product code: ASK-45703-POS... | the Instructions for Use (IFU) were inadvertently removed from the kit. | Class II | Arrow International Inc |
| Nov 10, 2014 | Arrow Nerve Block Component, Product Code: AB-18040-N: Permits placement of c... | Arrow is recalling certain lots of the Continuous Nerve Block Component, Product Code: AB-18040-... | Class II | Arrow International Inc |
| Sep 18, 2014 | Multi-Lumen Central Venous Catheterization Kit | Arrow International, Inc. has initiated a voluntary recall for product code AK- 12703, lot numbe... | Class II | Arrow International Inc |
| Sep 15, 2014 | ASK-05501-AFH1, Lot Number 23F13K0969 Anesthesia Conduction Catheter, Epidura... | Arrow International, Inc. is notifying customers that lot 23F13K0969 of product code ASK-05501-AF... | Class II | Arrow International Inc |
| Aug 6, 2014 | Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC) with BD Me... | The component supplier recalled their 0.9% Sodium Chloride Injection USP BD Posiflush SF Saline F... | Class II | Arrow International Inc |
| Apr 14, 2014 | Arrow¿ Percutaneous Sheath Introducer Kits The Percutaneous sheath introdu... | Arrow is recalling the Arrow¿ Percutaneous Sheath Introducer Kits due to dilator tip damage noted... | Class II | Arrow International Inc |
| Mar 24, 2014 | Arrow Pressure Injectable PICC Powered by Arrow VPS Stylet Catalogue number C... | Kits are packaged with the incorrect catheter. The kits contain a 40cm catheter and should contai... | Class II | Arrow International Inc |
| Nov 8, 2013 | Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB), 8 Fr 40 cc Mode... | Potential for a leak between the catheter and the bifurcate which would allow helium to escape to... | Class II | Arrow International Inc |
| Oct 9, 2013 | Arrow Transradial Artery Access products Arrow Transradial Artery Access p... | There is a risk that the introducer needles packaged within the kits can be partially or fully oc... | Class II | Arrow International Inc |
| Oct 9, 2013 | Continuous Peripheral Nerve Block Catheter Kit and Set Continuous Peripher... | A labeling inconsistency was discovered in which the lidstock states that the kit contains a stim... | Class II | Arrow International Inc |
| Jul 31, 2013 | Arrow International, Inc. Two-Lumen CVC Kit with Blue Flex Tip Catheter. The ... | Arrow is recalling the product due to a labeling inconsistency. One portion of the lidstock state... | Class II | Arrow International Inc |
| Jul 17, 2013 | Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter, catalo... | Arrow is recalling the Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter due ... | Class II | Arrow International Inc |
| Jul 17, 2013 | Arrowgard Blue and Arrowgard Blue Plus Pressure Injectable Central Venous Cat... | The labeling states that the kit contains Introducer Needle: Echogenic 18 Ga. x 2.5 (6.35cm) XTW... | Class II | Arrow International Inc |
| Mar 4, 2013 | Arrow/Teleflex Medical Berman Angiographic Balloon Catheter and Reverse Berma... | The product specifications sheet, part of the Instructions for Use (IFU), for the specified produ... | Class II | Arrow International Inc |
| Feb 4, 2013 | The Arrow Edge Hemodialysis Catheterization Set Long-Term Access and NextStep... | The tunneling sheath packaged within the kits can crack during placement. If the tunneling sheath... | Class II | Arrow International Inc |
| Nov 27, 2012 | Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 4... | Potential to have an internal leak at the fill port of the stainless steel tip, which may necessi... | Class II | Arrow International Inc |
| Nov 27, 2012 | Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr ... | Potential to have an internal leak at the fill port of the stainless steel tip, which may necessi... | Class II | Arrow International Inc |
| Jun 7, 2012 | Arrow International, Inc. 7FR 3-Lumen Arrowg+ard Blue Plus(R) Pressure Inject... | Arrow is recalling the product due to the possibility of voids in the catheter hub which could le... | Class II | Arrow International Inc |
| May 3, 2012 | Arrow Two-Lumen Central Venous Catheterization Set with Blue FlexTip(R) ARROW... | Lidstock of product does not contain chlorhexidine contraindication and contains wording "contain... | Class I | 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.