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.

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DateProductReasonClassFirm
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
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

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.