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Browse Device Recalls

168 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 168 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 168 FDA device recalls.

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DateProductReasonClassFirm
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.