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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 27, 2026 | 10mL Non-Sterile BD Luer-Lok Tip Syringe Only. Catalog Number: 301029. 850 bu... | During the bulk packaging process, some Luer Slip syringes were incorrectly included in a batch d... | Class II | Becton Dickinson & Company |
| Oct 14, 2025 | BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341; | BD has confirmed through internal testing that certain device trays failed routine biocompatibili... | Class II | Becton Dickinson & Company |
| Nov 16, 2023 | PosiFlush Prefilled Saline Syringe with General Pump Compatibility (10mL Syri... | An incorrect stopper was used in nine lots of 10mL BD PosiFlush Normal Saline Flush Syringes with... | Class II | Becton Dickinson & Company |
| Oct 11, 2023 | BD Alaris Pump infusion sets (Product Name, Catalog #) BD AlarisTM Pump In... | Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DE... | Class II | Becton Dickinson & Company |
| Oct 11, 2023 | BD Extension Sets (Product Name, Catalog #) BD SmartSite Filter Extension ... | Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DE... | Class II | Becton Dickinson & Company |
| Oct 11, 2023 | BD gravity sets (Product Name, Catalog #) 32-IN GRAV SET W/0.2 MICRON FILT... | Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DE... | Class II | Becton Dickinson & Company |
| Feb 1, 2023 | BD Insulin Syringes with the BD Micro-Fine TM IV Needle 1ml, 12.7mm, 28G Sin... | Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of lo... | Class II | Becton Dickinson & Company |
| Feb 1, 2023 | BD Ultra-Fine Insulin Syringe 1mL, 6mm, 31G-Insulin Syringes are designed for... | Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of lo... | Class II | Becton Dickinson & Company |
| Feb 1, 2023 | BD Ultra-Fine Insulin Syringe 1mL, 12.7mm, 29G-Insulin Syringes are designed ... | Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of lo... | Class II | Becton Dickinson & Company |
| Feb 1, 2023 | BD Insulin Syringes with the BD Micro-Fine IV Needle 1 ml, 12. 7mm, 28G Two U... | Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of lo... | Class II | Becton Dickinson & Company |
| Feb 1, 2023 | BD Ultra-Fine II Insulin Syringe 0.5mL, 8mm, 30G-Insulin Syringes are designe... | Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of lo... | Class II | Becton Dickinson & Company |
| Feb 1, 2023 | BD Ultra-Fine Insulin Syringe 0.5mL, 6mm, 31G - Insulin Syringes are designed... | Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of lo... | Class II | Becton Dickinson & Company |
| Feb 1, 2023 | BD Insulin Syringes with the BD Micro-Fine IV Needle 0.5ml, 12.7mm, 28G Singl... | Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of lo... | Class II | Becton Dickinson & Company |
| Feb 1, 2023 | BD Ultra-Fine Insulin Syringe 0.5mL, 8mm, 31G-Insulin Syringes are designed f... | Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of lo... | Class II | Becton Dickinson & Company |
| Sep 15, 2022 | BD Vacutainer Tube Sodium Fluoride: 100 mg, Potassium Oxalate: 20 mg, Catalog... | The affected product contains isobutylene which has recently demonstrated potential interference ... | Class II | Becton Dickinson & Company |
| Jul 18, 2022 | BD PhaSealTM Y-Site Connector (C80)- airtight and leak-proof Closed System Dr... | Incorrect expiration date listed on the product labels. The expiration date listed on the product... | Class II | Becton Dickinson & Company |
| May 9, 2022 | BD Connecta Stopcock with OFF Directed Tap Without Extension Tube (500 eaches... | May have the potential for leakage at the housing component of the stopcock, may result in delay ... | Class II | Becton Dickinson & Company |
| May 9, 2022 | BD Connecta 3-Way Stopcocks Catalog No. 394900 (OUS) | May have the potential for leakage at the housing component of the stopcock, may result in delay ... | Class II | Becton Dickinson & Company |
| May 9, 2022 | BD Connecta Stopcock Without Extension Tube Catalog No. 394605 (OUS) | May have the potential for leakage at the housing component of the stopcock, may result in delay ... | Class II | Becton Dickinson & Company |
| May 9, 2022 | BD Connecta" Plus3 White Blend OEM (sterile, bulk) Catalog No. 395214 (OUS) | May have the potential for leakage at the housing component of the stopcock, may result in delay ... | Class II | Becton Dickinson & Company |
| May 9, 2022 | BD Connecta" Plus1 360 Blue Blend Catalog No. 394911 (OUS) | May have the potential for leakage at the housing component of the stopcock, may result in delay ... | Class II | Becton Dickinson & Company |
| May 9, 2022 | Nexiva with Single BD Connecta Stopcock Version (20 Ga Blue) Catalog No.3836... | May have the potential for leakage at the housing component of the stopcock, may result in delay ... | Class II | Becton Dickinson & Company |
| May 9, 2022 | BD Connecta Stopcock Without Extension Tube Catalog No. 394602 (OUS) | May have the potential for leakage at the housing component of the stopcock, may result in delay ... | Class II | Becton Dickinson & Company |
| May 9, 2022 | BD Connecta White 360 Shelf 100Ea Catalog No. 395000 (OUS) | May have the potential for leakage at the housing component of the stopcock, may result in delay ... | Class II | Becton Dickinson & Company |
| May 9, 2022 | Nexiva with Single BD Connecta Stopcock Version (Pink) Catalog No. 383687 (OUS) | May have the potential for leakage at the housing component of the stopcock, may result in delay ... | Class II | Becton Dickinson & Company |
| May 9, 2022 | BD Connecta Stopcock Without Extension Tube Catalog No. 394600 (OUS) | May have the potential for leakage at the housing component of the stopcock, may result in delay ... | Class II | Becton Dickinson & Company |
| May 9, 2022 | BD Connecta Stopcock Without Extension Tube Catalog No. 394601 (OUS) | May have the potential for leakage at the housing component of the stopcock, may result in delay ... | Class II | Becton Dickinson & Company |
| Jan 6, 2022 | BD Vacutainer Luer Lok Access Device - intended as a sterile, single use devi... | May shed contaminant particles into the urine specimen that may be misidentified as Red Blood Cel... | Class III | Becton Dickinson & Company |
| Sep 27, 2021 | BD Syringe Tip Cap Bulk Sterile Convenience Pak-1000 units/shelf carton. Used... | Holes in product packaging impacts package integrity and may compromise sterility. | Class II | Becton Dickinson & Company |
| Dec 23, 2020 | BD Hypodermic Syringe 10 ml, eccentric tip. Catalog (Ref No.) 305482 | The product packaging for the 10 ml eccentric tip syringe may exhibit open seals. An open seal i... | Class II | Becton Dickinson & Company |
| Dec 9, 2020 | BD Stimex Insulated Needle 22G x 2.13in ( 50 units/cs.) Indicated for adminis... | BD was advised by the European Notified Body, NSAI, that the instructions for use (IFU) needs to ... | Class II | Becton Dickinson & Company |
| Dec 9, 2020 | BD Regional Block Needles 22G x 1.50in (50 units/cs.). Indicated for administ... | BD was advised by the European Notified Body, NSAI, that the instructions for use (IFU) needs to ... | Class II | Becton Dickinson & Company |
| Nov 18, 2020 | BD PrecisionGlide Needle 30G x 1/2 (0.3 mm X 13mm) REF 305106 - Product Usag... | BD has confirmed the presence of blood on the cannulas of the BD PrecisionGlide needles 30G X 1/2... | Class II | Becton Dickinson & Company |
| Oct 23, 2020 | BD Ultra-Fine Pen Needles 32G x 4mm (5/32' )-intended for parenteral administ... | Product shelf cartons incorrectly labeled as products intended for the Latin American market. Alt... | Class II | Becton Dickinson & Company |
| Sep 14, 2020 | Bard 3F SL PowerMidline Basic Kit CE-indicated for short term access to the p... | Kits do not contain the stylet/T-lock assembly indicated as a component on the label, may lead to... | Class II | Becton Dickinson & Company |
| Sep 14, 2020 | Bard 3F SL PowerMidline Full Kit CE-indicated for short term access to the pe... | Kits do not contain the stylet/T-lock assembly indicated as a component on the label, may lead to... | Class II | Becton Dickinson & Company |
| Sep 14, 2020 | BD Nexiva Closed IV Catheter System Dual Port (20 GA 1.75 IN) Catalog (Ref... | Dull/blunt needles within the IV Catheter System may lead to missed insertion attempts and delay ... | Class II | Becton Dickinson & Company |
| Jul 28, 2020 | BD SafetyGlideTM 3ml 25G x 1 3mL SafetyGlide syringes, 50 units in pack | Printed scale markings on the 3mL SafetyGlide syringes, with catalog # 305924, Lot# 8289599, are ... | Class II | Becton Dickinson & Company |
| Jun 19, 2020 | SafeStep Huber Needle Set; Catalog Numbers LH-0029 (UDI 00801741066160), LH-... | Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. De... | Class II | Becton Dickinson & Company |
| Jun 19, 2020 | PowerLoc MAX Power Injectable Infusion Set with GuardIVa Antimicrobial Hemost... | Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. De... | Class II | Becton Dickinson & Company |
| Jun 19, 2020 | SafeStep Huber Needle Set AllPoints Port Access System; Catalog Numbers AN152... | Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. De... | Class II | Becton Dickinson & Company |
| Jun 19, 2020 | SafeStep Huber Needle Set myPICK Port Access Kit; Catalog Numbers CPA00020A (... | Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. De... | Class II | Becton Dickinson & Company |
| Jun 19, 2020 | SafeStep Huber Needle Set with Y Injection Site and Medegen Needleless Inject... | Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. De... | Class II | Becton Dickinson & Company |
| Jun 19, 2020 | PowerLoc MAX Power Injectable Infusion Set AllPoints Port Access System; Cata... | Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. De... | Class II | Becton Dickinson & Company |
| Jun 19, 2020 | PowerLoc MAX Power-Injectable Infusion Set myPICK Port Access Kit; Catalog Nu... | Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. De... | Class II | Becton Dickinson & Company |
| Jun 19, 2020 | SafeStep Huber Needle Set Port Access Kit; Catalog Numbers PA-0029 (UDI 00801... | Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. De... | Class II | Becton Dickinson & Company |
| Jun 19, 2020 | SafeStep Huber Needle Set with GuardIVa Antimicrobial Hemostatic Dressing Por... | Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. De... | Class II | Becton Dickinson & Company |
| Jun 19, 2020 | PowerLoc MAX Power Injectable Infusion Set; Catalog Numbers 0131910 (UDI 0080... | Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. De... | Class II | Becton Dickinson & Company |
| Jun 19, 2020 | SafeStep Huber Needle Set with GuardIVa Antimicrobial Hemostatic Dressing; Ca... | Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. De... | Class II | Becton Dickinson & Company |
| Jun 19, 2020 | PowerLoc MAX Power Injectable Infusion Port Access Kit; Catalog Numbers 21319... | Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. De... | 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.