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 |
|---|---|---|---|---|
| May 13, 2019 | BD Microtainer SST- Amber Part/Catalog Number: 365978 | Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for test... | Class II | Becton Dickinson & Company |
| May 13, 2019 | BD Microtainer PSTTubes with LH (Lithium Heparin) Part/Catalog Number:365985 | Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for test... | Class II | Becton Dickinson & Company |
| May 6, 2019 | Alaris Pump Infusion Set, Model Codes 10010453, 10010454, 10012144, 10015294,... | An incomplete occlusion can be caused by a variation in the wall thickness of the pumping segment... | Class I | Becton Dickinson & Company |
| May 2, 2019 | CareFusion MaxPlus Clear Needleless Connector. Intended for Positive Displace... | After disconnection of a luer, the valve of the connector remains recessed; not fully closing, ei... | Class II | Becton Dickinson & Company |
| Apr 10, 2019 | MaxZero Extension Sets with Needle-less Connector, Product codes MZ1000 MZ10... | BD has decided to initiate a voluntary recall due to a confirmed complaint trend for droplets of... | Class II | Becton Dickinson & Company |
| Mar 7, 2019 | BD Blood Collection Assembly with Male Luer Lock, Catalog Number MBC6010 | The luer could break and cause the device to leak or break off and get stuck in the fistula needl... | Class II | Becton Dickinson & Company |
| Mar 7, 2019 | BD Vacutainer Eclipse Blood Collection Needles 22Gx1.25, cat. no. 368608 | BD PAS received customer complaints indicating the absence of the bevel on the non-patient needle... | Class II | Becton Dickinson & Company |
| Mar 5, 2019 | Gravity IV Set with 3-port Closed Stopcock Manifold Model CS42522E-07 | The firm has initiated a recall due to a confirmed complaint trend for kinked tubing on the spec... | Class II | Becton Dickinson & Company |
| Mar 5, 2019 | Gravity IV Set with 3-port Closed Stopcock Manifold Model CM42500E-07 | The firm has initiated a recall due to a confirmed complaint trend for kinked tubing on the spec... | Class II | Becton Dickinson & Company |
| Mar 1, 2019 | BD Nexiva Dual Port 20GA 1.00IN -Closed IV Catheter System intended for use i... | Leak from the septum assembly or the canister may burst under high pressure which could result in... | Class II | Becton Dickinson & Company |
| Feb 28, 2019 | SmartSite Syringe Administration Set-Product Package Size 50, Catalog Numbe... | Leaking of the Smartsite Syringe Administration Set. May result in delay or interruption of infu... | Class I | Becton Dickinson & Company |
| Feb 1, 2019 | 3mL Safety-Lok Syringe, Catalog Number 309606, UDI 30382903096061 | The syringes have scale markings that were printed incorrectly. The scale is skewed to varying de... | Class II | Becton Dickinson & Company |
| Feb 1, 2019 | 3mL Luer-Lok Syringe, Catalog Number 309657, UDI 30382903096573 | The syringes have scale markings that were printed incorrectly. The scale is skewed to varying de... | Class II | Becton Dickinson & Company |
| Sep 26, 2018 | PCEA ASV Yellow Microbore, Catalog Numbers 30893, 30893-07 Product Usage: ... | The products have the potential to leak between the connection of the male luer lock and the yell... | Class II | Becton Dickinson & Company |
| Sep 26, 2018 | PCEA Kit ASV Yellow Stripe Microbore, Catalog Number 10800177 Product Usag... | The products have the potential to leak between the connection of the male luer lock and the yell... | Class II | Becton Dickinson & Company |
| Aug 30, 2018 | BD Vacutainer Specimen Collection Cups, Cat. No. 364975 | BD Vacutainer Urine Collection Cups may contribute to a slight elevation of Red Blood Cell (RBC) ... | Class II | Becton Dickinson & Company |
| Aug 30, 2018 | KIT URIN CUP PLC 16X100 10.0 UA YEL, Cat. No. 364981: Urine Collection Kit fo... | BD Vacutainer Urine Collection Cups may contribute to a slight elevation of Red Blood Cell (RBC) ... | Class II | Becton Dickinson & Company |
| Aug 30, 2018 | KIT URIN CUP 16X100 8.0 CONI UA YEL, Cat. No. 364989 BD Vacutainer Urine Cup... | BD Vacutainer Urine Collection Cups may contribute to a slight elevation of Red Blood Cell (RBC) ... | Class II | Becton Dickinson & Company |
| Aug 30, 2018 | BD Vacutainer Urine Collection Cups, Cat. No. 364941 | BD Vacutainer Urine Collection Cups may contribute to a slight elevation of Red Blood Cell (RBC) ... | Class II | Becton Dickinson & Company |
| Aug 23, 2018 | BD NEXIVA Closed IV Catheter System Dual Port 18GA 1.25 IN (BD Nexiva Cathete... | One lot of the specified needles is not performing as intended due to a failure in the needle tip... | Class II | Becton Dickinson & Company |
| Apr 11, 2018 | The BD Vacutainer Plus Plastic Citrate Blood Collection Tube is an evacuated ... | Approximately 3.4% of BD Vacutainer Plus Plastic Citrate Blood Collection Tubes (2.7mL) (light bl... | Class II | Becton Dickinson & Company |
| Apr 11, 2018 | The BD Vacutainer Plus Plastic Citrate Blood Collection Tube is an evacuated ... | Approximately 3.4% of BD Vacutainer Plus Plastic Citrate Blood Collection Tubes (2.7mL) (light bl... | Class II | Becton Dickinson & Company |
| Apr 11, 2018 | The BD Vacutainer Plus Plastic Citrate Blood Collection Tube is an evacuated ... | Approximately 3.4% of BD Vacutainer Plus Plastic Citrate Blood Collection Tubes (2.7mL) (light bl... | Class II | Becton Dickinson & Company |
| Mar 22, 2018 | BD Vacutainer¿ EDTA Lavender Top Tubes: Catalog Numbers: 1. 366401 (UDI: 5038... | BD Vacutainer EDTA Lavender, Tan, and Pink Top Tubes and BD Vacutainer Lithium Heparin Green Top ... | Class I | Becton Dickinson & Company |
| Mar 22, 2018 | BD Vacutainer¿ EDTA Tan Top Tube; Catalog Number: 367855 (UDI: 50382903678551) | BD Vacutainer EDTA Lavender, Tan, and Pink Top Tubes and BD Vacutainer Lithium Heparin Green Top ... | Class I | Becton Dickinson & Company |
| Mar 22, 2018 | BD Vacutainer¿ EDTA Pink Top Tube; Catalog Numbers: 1. 367842 (UDI: 503829036... | BD Vacutainer EDTA Lavender, Tan, and Pink Top Tubes and BD Vacutainer Lithium Heparin Green Top ... | Class I | Becton Dickinson & Company |
| Mar 22, 2018 | BD Vacutainer¿ Lithium Heparin Green Top Tube; Catalog Numbers: 1. 366664 (UD... | BD Vacutainer EDTA Lavender, Tan, and Pink Top Tubes and BD Vacutainer Lithium Heparin Green Top ... | Class I | Becton Dickinson & Company |
| Mar 20, 2018 | BD Vacutainer¿ Push Button Blood Collection Set 0.6 x 19 mm x 305 mm 23G x ¿... | Products do not meet the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6. | Class II | Becton Dickinson & Company |
| Mar 20, 2018 | BD Vacutainer¿ Push Button Blood Collection Set 0.8 x 19 mm x 305 mm 21G x ¿ ... | Products do not meet the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6. | Class II | Becton Dickinson & Company |
| Mar 20, 2018 | BD Vacutainer¿ Ultra TouchTM Push Button Blood Collection Set 0.6 x 19 mm x 3... | Products do not meet the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6. | Class II | Becton Dickinson & Company |
| Feb 13, 2018 | BD VACUTAINER PLUS SST Tube with HEMOGARD closure 13x75mm 3.5ml PLBL Gold, Ca... | Tubes may exhibit stopper creepout/pullout, where the stopper dissociates from the tube | Class II | Becton Dickinson & Company |
| Feb 13, 2018 | BD VACUTAINER PLUS SST Tube with HEMOGARD closure 13x100mm 5.0ml PLBL Gold, C... | Tubes may exhibit stopper creepout/pullout, where the stopper dissociates from the tube | Class II | Becton Dickinson & Company |
| Sep 18, 2017 | BD Vacutainer¿ Barricor" Lithium Heparin Plasma Blood Collection Tubes for In... | Increased amount of residual blood present on the top of stopper well after venipuncture | Class II | Becton Dickinson & Company |
| Aug 29, 2017 | BD Vacutainer¿ K2 EDTA (K2E) 3.6mg Blood Collection Tube (13 x 75 mm x 2.0 mL... | A limited portion of the lot was manufactured with less than the required amount of K2EDTA additi... | Class II | Becton Dickinson & Company |
| Jun 13, 2017 | BD Needle 22GA 1-1/2in SafetyGlide(TM) Non Sterile, Bulk, REF 301701 The B... | Presence of loose polypropylene foreign matter above release specification. | Class II | Becton Dickinson & Company |
| May 31, 2017 | BD Precision Glide Needle 18G x 1 RB, Catalog 305195 Product Usage: Thes... | Hub damage resulting in breakage and/or leakage during use. | Class II | Becton Dickinson & Company |
| May 25, 2017 | BD Insulin Syringes with the BD Ultra-Fine(TM) needle ¿ mL 12.7mm 30G, Catalo... | Product mislabel. Lot 6291768 of the BD Insulin Syringes with the BD Ultra-Fine needle ¿mL 12.7m... | Class II | Becton Dickinson & Company |
| Mar 16, 2017 | BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tubes, 4.5 mL, ... | BD is initiating this product correction of multiple lots of BD Vacutainer Buffered Sodium Citrat... | Class II | Becton Dickinson & Company |
| Jan 27, 2017 | BD Vacutainer Sodium Polyanetholesulfonate 5.95 mg Sodium Chloride 14.4 mg Bl... | After a receiving a customer complaint for incorrect labeling, BD has confirmed that a portion of... | Class II | Becton Dickinson & Company |
| Jan 16, 2017 | BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tube (4.5 ml x... | A portion of this lot of blood collection tubes was manufactured with approximately twice the exp... | Class II | Becton Dickinson & Company |
| Dec 23, 2016 | BD FlowSmart Set MiniMed Pro-set Rx Only Distributed by Medtronic MiniMed ... | Patients are reporting high blood glucose (HBG) levels while using the MiniMed Pro-set and also n... | Class II | Becton Dickinson & Company |
| Dec 20, 2016 | Eclipse Hypodermic Needle | BD is initiating a Product Advisory for the Eclipse Hypodermic Needle because of safety complaint... | Class II | Becton Dickinson & Company |
| Nov 7, 2016 | BD Spinal Anesthesia Tray The BD Spinal Anesthesia Tray is intended for use ... | BD is conducting a voluntary product recall of the BD Spinal Anesthesia Tray, Cat (Ref) 405671, l... | Class II | Becton Dickinson & Company |
| Sep 16, 2016 | BD 3ml Syringe Luer-Lok" Tip with BD PrecisionGlide" Needle 23G x 1 (0.6mm x ... | BD identified that several lots did not receive the specified dose of irradiation necessary to me... | Class II | Becton Dickinson & Company |
| Sep 16, 2016 | BD SafetyGlide" Injection Needle Catalog #305917 The SafetyGlide " needle i... | BD identified that several lots did not receive the specified dose of irradiation necessary to me... | Class II | Becton Dickinson & Company |
| Sep 16, 2016 | BD 3ml Syringer Luer-Lok Tip Catalog #309604 The BD Single Use, Hypodermic ... | BD identified that several lots did not receive the specified dose of irradiation necessary to me... | Class II | Becton Dickinson & Company |
| Sep 16, 2016 | BD 3ml Syringe Luer-Lok" Tip with BD PrecisionGlide" Needle 18G x 1 1/2 (1.2m... | BD identified that several lots did not receive the specified dose of irradiation necessary to me... | Class II | Becton Dickinson & Company |
| Sep 16, 2016 | BD 3ml Syringe Luer-Lok" Tip Catalog 309657 The BD Single Use, Hypodermic S... | BD identified that several lots did not receive the specified dose of irradiation necessary to me... | Class II | Becton Dickinson & Company |
| Sep 16, 2016 | BD 5ml Syringe Luer-Lok" Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 40mm... | BD identified that several lots did not receive the specified dose of irradiation necessary to me... | Class II | Becton Dickinson & Company |
| Sep 16, 2016 | BD 10mL Syringe Luer-Lok Tip Catalog number 301997 The BD Single Use, Hypode... | BD identified that several lots did not receive the specified dose of irradiation necessary to me... | Class II | 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.