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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Date	Product	Reason	Class	Firm
Apr 16, 2020	BD Posiflush SF Saline Flush Syringe (US Distributed Catalog 306553), UDI 503...	This product has been confirmed to exhibit holes in the packaging, which impacts package integrit...	Class II	Becton Dickinson & Company
Mar 26, 2020	CareFusion Safe-T-Centesis Catheter Drainage Tray, Sterile, For Single Use On...	The 8 Fr catheter was manufactured with the 6.9 Fr needle instead of the 8 Fr needle.	Class II	Becton Dickinson & Company
Mar 17, 2020	PowerGlide ST Midline Catheter Maximal Barrier Kit-18 gauge,10 cm length Cat...	Iincorrectly packaged without the required lidocaine as labeled	Class II	Becton Dickinson & Company
Feb 26, 2020	BARD MYPICC KIT 3F Single-Lumen, Catalog Number CK000417B	The kits contain surgical gowns which were subject to a recall by the supplier.	Class II	Becton Dickinson & Company
Feb 26, 2020	BARD MYPICC KIT 5F Dual-Lumen, Catalog Number CK000025	The kits contain surgical gowns which were subject to a recall by the supplier.	Class II	Becton Dickinson & Company
Feb 26, 2020	BARD MYPICC KIT 4F Dual-Lumen, Catalog Number CK000418B	The kits contain surgical gowns which were subject to a recall by the supplier.	Class II	Becton Dickinson & Company
Feb 26, 2020	BARD MYPICC KIT 5F Triple-Lumen, Catalog Number CK000278	The kits contain surgical gowns which were subject to a recall by the supplier.	Class II	Becton Dickinson & Company
Feb 26, 2020	BARD MYPICC KIT 4F Single-Lumen, Catalog Number CK000276	The kits contain surgical gowns which were subject to a recall by the supplier.	Class II	Becton Dickinson & Company
Feb 26, 2020	BARD MYPICC KIT 5F Triple-Lumen, Catalog Number CK000026A	The kits contain surgical gowns which were subject to a recall by the supplier.	Class II	Becton Dickinson & Company
Feb 26, 2020	BARD MYPICC KIT 5F Dual-Lumen, Catalog Number CK000435	The kits contain surgical gowns which were subject to a recall by the supplier.	Class II	Becton Dickinson & Company
Feb 26, 2020	BARD MYPICC KIT 5F Dual-Lumen, Catalog Number CK000277	The kits contain surgical gowns which were subject to a recall by the supplier.	Class II	Becton Dickinson & Company
Nov 4, 2019	Site~Rite 8 Ultrasound Systems-intended for diagnostic ultrasound imaging of ...	The indicator may show available charge when the battery is close to depletion. As a result, the ...	Class II	Becton Dickinson & Company
Oct 14, 2019	BD Posiflush Pre-Filled Normal Saline Syringes Catalog Number: 306547	Limited number of syringes labeled Posiflush Experimental Product and Not for Human Use being...	Class II	Becton Dickinson & Company
Oct 14, 2019	BD Posiflush Pre-Filled Normal Saline Syringes Catalog Number: 306575 (Canad...	Limited number of syringes labeled Posiflush Experimental Product and Not for Human Use being...	Class II	Becton Dickinson & Company
Sep 16, 2019	13 Fr. Trialysis Catheter with Alphacurve. Catalog No. 5653150. UDI: 00801741...	A portion of the lot was incorrectly packaged with a 12.5cm catheter instead of a 15cm catheter.	Class II	Becton Dickinson & Company
Aug 1, 2019	8 G x 10 CM Jamshidi Crown Bone Marrow biopsy/Aspiration Needle with MAC Cat...	Product Pouches may not be sealed properly and compromise the sterility of the device	Class II	Becton Dickinson & Company
Jul 31, 2019	BD Vacutainer¿ Push Button Blood Collection Set with Pre-Attached Holder Ca...	Separation of front and rear barrels upon activation of the safety feature that retracts the needle	Class II	Becton Dickinson & Company
Jun 12, 2019	BD Vacutainer PST Gel and Lithium HeparinN (LH) 65 Units Blood Collection Tub...	False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood ga...	Class II	Becton Dickinson & Company
Jun 12, 2019	BD Vacutainer PST Gel and Lithium HeparinN (LH) Blood Collection Tubes, Catal...	False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood ga...	Class II	Becton Dickinson & Company
Jun 12, 2019	BD Vacutainer Lithium HeparinN (LH) 158 USP Units Blood Collection Tubes, Cat...	False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood ga...	Class II	Becton Dickinson & Company
Jun 12, 2019	BD Vacutainer PST Blood Collection Tubes, Catalog Number 368035, 368036	False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood ga...	Class II	Becton Dickinson & Company
Jun 12, 2019	BD Vacutainer LH (Lithium Heparin) 102 I.U. Plus Blood Collection Tubes, Cata...	False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood ga...	Class II	Becton Dickinson & Company
Jun 12, 2019	BD Vacutainer Lithium HeparinN 75 USP Units Blood Collection Tubes, Catalog N...	False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood ga...	Class II	Becton Dickinson & Company
Jun 12, 2019	BD Vacutainer LH (Lithium Heparin) 68 I.U. Plus Blood Collection Tubes, Catal...	False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood ga...	Class II	Becton Dickinson & Company
Jun 12, 2019	BD Vacutainer PST Gel and Lithium HeparinN (LH) 83 Units Blood Collection Tub...	False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood ga...	Class II	Becton Dickinson & Company
Jun 12, 2019	BD Vacutainer PST Gel and Lithium HeparinN (LH) 56 Units Blood Collection Tub...	False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood ga...	Class II	Becton Dickinson & Company
Jun 12, 2019	BD Vacutainer Lithium HeparinN (LH) 56 USP Units Blood Collection Tubes, Cata...	False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood ga...	Class II	Becton Dickinson & Company
Jun 12, 2019	BD Vacutainer LH (Lithium Heparin) 34 I.U. Plus Blood Collection Tubes, Catal...	False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood ga...	Class II	Becton Dickinson & Company
Jun 12, 2019	BD Vacutainer Lithium HeparinN (LH) 37 USP Units Blood Collection Tubes, Cata...	False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood ga...	Class II	Becton Dickinson & Company
Jun 12, 2019	BD Vacutainer PST Gel and Lithium HeparinN (LH) 126 Units Blood Collection Tu...	False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood ga...	Class II	Becton Dickinson & Company
Jun 12, 2019	BD Vacutainer PST Gel and Lithium HeparinN (LH) 56 Units Blood Collection Tub...	False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood ga...	Class II	Becton Dickinson & Company
Jun 12, 2019	BD Vacutainer Lithium HeparinN (LH) 95 USP Units Blood Collection Tubes, Cata...	False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood ga...	Class II	Becton Dickinson & Company
Jun 3, 2019	BD Microtainer Tube w/ BD Microgard Closure, K2EDTA additive, Model Numbers 3...	The products have been confirmed to have reduced or no additive within the tube reservoir. The t...	Class II	Becton Dickinson & Company
May 30, 2019	BD Vacutainer Fluoride Tubes for Blood Alcohol determinations Part Number: 3...	Lot has been confirmed to have no additive within the tube. Sample processed without the preserva...	Class II	Becton Dickinson & Company
May 13, 2019	BD MicrotainerTubes with K2E (K2EDTA) Catalog Number: 365974	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 Tubes with FE (Sodium Fluoride / Disodium EDTA) Glycolytic Inh...	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 Tubes with LH (Lithium Heparin) Part/Catalog No.365965	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 Z (No Additive Tubes) Part/Catalog No.365963	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 PST Tubewith LH (Lithium Heparin) - Amber Part/Catalog Nu...	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 SST Part/Catalog No.365967	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 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

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.