Browse Device Recalls
178 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 178 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 178 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 8, 2016 | BD Vacutainer Push Button Blood Collection Set, Sterile, Rx only, 0.6 x 19 mm... | Becton Dickinson is recalling various lot numbers of BD Vacutainer Push Button Blood Collection S... | Class II | Becton Dickinson & Company |
| Aug 8, 2016 | BD 23 G x .75 in. BD Vacutainer¿ Push Button Blood Collection Set with 12 in... | BD has received multiple reports of units associated with the 23 G x .75 in. BD Vacutainer¿ Push... | Class II | Becton Dickinson & Company |
| Aug 2, 2016 | catalog # 405612 BD Spinal Anesthesia Tray 22G x 3.5 in. BD" Quincke Spinal... | A recall was initiated by Hospira, Inc. for several lots of 5% Lidocaine HCI and 7.5% Dextrose In... | Class II | Becton Dickinson & Company |
| Mar 25, 2016 | Henry Schein Single Use Syringe Luer-Lock, 10 mL, Intended for use by health ... | BD 10 mL Syringe Luer-Lok Tip with BD PrecisionGlide Needle 21G x 1 (0.8 mm x 25 mm) and Henry Sc... | Class II | Becton Dickinson & Company |
| Mar 25, 2016 | Henry Schein Single Use Syringe Luer-Lock, 10 mL, Intended for use by heal... | BD 10 mL Syringe Luer-Lok Tip with BD PrecisionGlide Needle 21G x 1 (0.8 mm x 25 mm) and Henry Sc... | Class II | Becton Dickinson & Company |
| Mar 18, 2016 | 1) 24 G x 0.75 in. BD Angiocath" Autoguard" shielded IV catheter (0.7 mm x 1... | The device may have a defect in the catheter. In some instances this defect could result in cathe... | Class II | Becton Dickinson & Company |
| Dec 9, 2015 | BD Intelliport Medication Management System Sensor The system is indicated... | The sterility of the product cannot be assured. This may result in increased risk of infection. | Class II | Becton Dickinson & Company |
| Dec 3, 2015 | BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 3.0 mL (Tan) BD Hemo... | Some of the Blood Collection Tubes in these lots were manufactured with insufficient EDTA additiv... | Class II | Becton Dickinson & Company |
| Dec 3, 2015 | BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 2.0 mL (Pink) BD Hem... | Some of the Blood Collection Tubes in these lots were manufactured with insufficient EDTA additiv... | Class II | Becton Dickinson & Company |
| Dec 3, 2015 | BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 2.0 mL (Pink) BD Hem... | Some of the Blood Collection Tubes in these lots were manufactured with insufficient EDTA additiv... | Class II | Becton Dickinson & Company |
| Dec 3, 2015 | BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 4.0 mL (Lavender) BD... | Some of the Blood Collection Tubes in these lots were manufactured with insufficient EDTA additiv... | Class II | Becton Dickinson & Company |
| Dec 3, 2015 | BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 3.0 mL (Lavender) BD... | Some of the Blood Collection Tubes in these lots were manufactured with insufficient EDTA additiv... | Class II | Becton Dickinson & Company |
| Nov 17, 2015 | BD Vacutainer K2 EDTA (K2E) 5.4mg Plus Blood Collection Tubes. Product Us... | Some tubes were manufactured with the stopper not fully inserted into the tube. This may result i... | Class II | Becton Dickinson & Company |
| Jun 23, 2015 | BD Vacutainer SST Plus Blood Collection Tubes, 5.0 mL, 13 x 100 mm, Sterile. ... | Some of the tubes were manufactured with stoppers that did not meet current manufacturing specifi... | Class III | Becton Dickinson & Company |
| Feb 19, 2015 | BD Q-Syte Luer Access Split Septum, 0.16 ml, Sterile, Rx only, Catalog REF #3... | Becton Dickinson received an elevated number of complaints for blood or infusate/medication leaka... | Class II | Becton Dickinson & Company |
| Dec 19, 2014 | BD 10 mL Syringe BD Luer-Lok Tip with Blunt Plastic Cannula, Not for Skin Inj... | The stopper of the 10mL BD Luer-Lok syringe is not properly seated in the syringe. | Class II | Becton Dickinson & Company |
| Oct 9, 2014 | BD Insyte Autoguard Catheter An active safety engineered peripheral IV cat... | BD Insyte Autoguard may have potential damage along the body of the catheter. | Class II | Becton Dickinson & Company |
| Jul 22, 2014 | BD PosiFlush SF Saline Flush Syringe 0.9 Sodium Chloride Injection, USP 10 mL... | BD received some reports of open seals found on the BD Posiflush SF Flush Syringe 10 mL (Ref #306... | Class II | Becton Dickinson & Company |
| Jul 3, 2014 | BD Vacutainer CPT Cell Preparation Tube with Sodium Heparin, 8 mL, 16 x 125 m... | BD has initiated the recall of its Vacutainer CPT Cell Preparation Tube due to poor separation, r... | Class II | Becton Dickinson & Company |
| Nov 26, 2013 | BD Interlink threaded lock cannula This is a locking blunt plastic cannula s... | BD Interlink Threaded Lock Cannula REF# 303369 and lot #3021392 is being recalled due to the pote... | Class II | Becton Dickinson & Company |
| Aug 23, 2013 | BD Epilor Syringe BD Franklin Lakes, NJ 07417 BD EDC Laagstraat 57, B-914... | BD has received several reports indicating that the plunger of the 7 mL BD Epilor plastic BD Luer... | Class II | Becton Dickinson & Company |
| Jul 10, 2013 | BD Microtainer Quikheel Lancet 1.0 mm incision Depth 2.5 mm Incision Length R... | The Lancet will not retract after activation thus creating a potential for exposure to a used sharp. | Class II | Becton Dickinson & Company |
| May 1, 2013 | BD Vacutainer Multiple Sample and Direct Draw Luer Adapter BD Franklin Lakes... | BD Vacutainer Multiple Sample and Direct Draw Luer Adapter may have blood leakage and low draw vo... | Class II | Becton Dickinson & Company |
| May 1, 2013 | BD SafetyGlide Allergy. REF 305950 Sterile Allergy Treatment Syringe Tray. ... | There has been an increase in complaints regarding the needle/safety mechanism disengaging from t... | Class II | Becton Dickinson & Company |
| Feb 14, 2013 | BD Vacutainer C&S Transfer Straw Kit C&S Preservative Plus Urine Tube. 4.0 m... | The BD Vacutainer Urinalysis Transfer Straw Kit #364991, Lot 1335484 has preprinted polybags whic... | Class III | Becton Dickinson & Company |
| Nov 12, 2012 | BD Vacutainer Buffered Sodium Citrate (9NC) Plus Blood Collection Tubes; Ster... | BD is conducting a recall of the BD Vacutainer 2.7mL Plus Citrate Blood Collection Tube due to ex... | Class II | Becton Dickinson & Company |
| Oct 2, 2012 | Case Carton: BD Oral Dispensing Syringe 1 mL Clear with Tip Cap BD, Fran... | BD received a complaint report for mixed syringe tips (oral and non-oral syringe tips) within the... | Class II | Becton Dickinson & Company |
| Mar 5, 2012 | BD Vacutainer PST Gel and Lithium Heparin (LH); 83 Units; Plus Blood Collecti... | BD is conducting a recall of the BD Vacutainer Plus Plastic Plasma Separator Tube (PST) with Ligh... | Class III | Becton Dickinson & Company |
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.