Browse Device Recalls

2,817 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,817 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 2,817 FDA device recalls in 2025.

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Date	Product	Reason	Class	Firm
Sep 11, 2025	BRONCHOVIDEOSCOPE OLYMPUS BF-H1100	Additional IFU updates to provide further clarification on safe and effective use of bronchoscope...	Class I	Olympus Corporation of the Americas
Sep 11, 2025	LGX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404405 (12C...	The potential for devices to experience inflation and/or deflation performance issues or difficul...	Class II	Boston Scientific Corporation
Sep 11, 2025	EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P180	Additional IFU updates to provide further clarification on safe and effective use of bronchoscope...	Class I	Olympus Corporation of the Americas
Sep 11, 2025	TENACIO Pump with InhibiZone; UPN: 72404429;	The potential for devices to experience inflation and/or deflation performance issues or difficul...	Class II	Boston Scientific Corporation
Sep 11, 2025	EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190	Additional IFU updates to provide further clarification on safe and effective use of bronchoscope...	Class I	Olympus Corporation of the Americas
Sep 11, 2025	BRONCHOFIBERSCOPE OLYMPUS BF TYPE PE2	Additional IFU updates to provide further clarification on safe and effective use of bronchoscope...	Class I	Olympus Corporation of the Americas
Sep 11, 2025	iNSitu Bipolar Hip System, Bipolar head implant Part ID Description 10-22...	Downstream recall for RES 97605, BioPro femoral components. Product failed transit testing. Impac...	Class II	Theken Companies LLC
Sep 11, 2025	BRONCHOVIDEOSCOPE OLYMPUS BF-1TQ170	Additional IFU updates to provide further clarification on safe and effective use of bronchoscope...	Class I	Olympus Corporation of the Americas
Sep 11, 2025	EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180-AC	Additional IFU updates to provide further clarification on safe and effective use of bronchoscope...	Class I	Olympus Corporation of the Americas
Sep 11, 2025	BRONCHOVIDEOSCOPE OLYMPUS BF-1TH1100	Additional IFU updates to provide further clarification on safe and effective use of bronchoscope...	Class I	Olympus Corporation of the Americas
Sep 11, 2025	EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T180	Additional IFU updates to provide further clarification on safe and effective use of bronchoscope...	Class I	Olympus Corporation of the Americas
Sep 11, 2025	ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection...	The devices were shipped unsterilized.	Class II	Ethicon Endo-Surgery Inc
Sep 11, 2025	BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P150	Additional IFU updates to provide further clarification on safe and effective use of bronchoscope...	Class I	Olympus Corporation of the Americas
Sep 11, 2025	TENACIO Pump without InhibiZone; UPN: 72404420;	The potential for devices to experience inflation and/or deflation performance issues or difficul...	Class II	Boston Scientific Corporation
Sep 11, 2025	FERNO POWER X2 POWERED AMBULANCE COT, Model/Catalog Number: 0015816; FOR USE ...	The fastening post hardware could loosen allowing the fastening post to detach from the cot	Class II	Ferno-Washington Inc
Sep 11, 2025	OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE 1T60	Additional IFU updates to provide further clarification on safe and effective use of bronchoscope...	Class I	Olympus Corporation of the Americas
Sep 11, 2025	BRONCHOFIBERSCOPE OLYMPUS BF TYPE TE2	Additional IFU updates to provide further clarification on safe and effective use of bronchoscope...	Class I	Olympus Corporation of the Americas
Sep 11, 2025	OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XT40	Additional IFU updates to provide further clarification on safe and effective use of bronchoscope...	Class I	Olympus Corporation of the Americas
Sep 11, 2025	BD Alaris Pump Infusion Sets for the following reference numbers: C24101E, ...	Infusion pump module used with compatible pump infusion sets may perform outside the establishe...	Class I	CareFusion 303, Inc.
Sep 11, 2025	EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE XT160	Additional IFU updates to provide further clarification on safe and effective use of bronchoscope...	Class I	Olympus Corporation of the Americas
Sep 11, 2025	Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Num...	Medline has identified a limited quantity of saline IV flush syringes that may not meet the requi...	Class II	Medline Industries, LP
Sep 10, 2025	TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DF, (BiD Curve D-F), ...	Abbott has become aware of a limited number of tip detachment events during catheter removal from...	Class I	Abbott
Sep 10, 2025	Medline Adult Anesthesia Set, REF DYNJ39985G	Specific items and lots of Medline Kits may contain Clearlink IV Sets which Baxter recalled due t...	Class II	Medline Industries, LP
Sep 10, 2025	TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F, (UniD Curve F), RE...	Abbott has become aware of a limited number of tip detachment events during catheter removal from...	Class I	Abbott
Sep 10, 2025	TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curve D), RE...	Abbott has become aware of a limited number of tip detachment events during catheter removal from...	Class I	Abbott
Sep 10, 2025	TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), ...	Abbott has become aware of a limited number of tip detachment events during catheter removal from...	Class I	Abbott
Sep 10, 2025	TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), ...	Abbott has become aware of a limited number of tip detachment events during catheter removal from...	Class I	Abbott
Sep 9, 2025	NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I	The unexpected internal fault / system diagnostic error to result when a rapid succession of butt...	Class I	NOXBOX LTD
Sep 9, 2025	BioPro Femoral Head (Ceramic heads 28-30) Product ID/Description 19023 HE...	Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of...	Class II	BioPro, Inc.
Sep 9, 2025	BioPro Endo Head (Metal uni-polar, 38-55) Product Number/Description 10...	Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of...	Class II	BioPro, Inc.
Sep 9, 2025	BioPro Femoral Head Product ID/Description 14089 HEAD FEMORAL 28 SH LT ...	Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of...	Class II	BioPro, Inc.
Sep 9, 2025	BioPro Endo Head (Ceramic) Product ID/Description 13006 ENDO MODULAR CERA...	Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of...	Class II	BioPro, Inc.
Sep 9, 2025	Juggerknot Mini Soft Anchors, Model/Catalog Number: 912080	The outer carton box label is for the JuggerKnot 1.0mm Mini products. However, the products withi...	Class II	Biomet, Inc.
Sep 9, 2025	Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 ...	The device either indicated a failure of the piston ventilator before use or suffered a failure o...	Class I	Draeger, Inc.
Sep 9, 2025	BioPro Femoral Head (Metal 22, 28, 32, 36, 40) cobalt chromium and ceramic he...	Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of...	Class II	BioPro, Inc.
Sep 9, 2025	BioPro Bipolar Head Product ID/Description 18130 BIPOLAR HEAD 38MM 18131...	Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of...	Class II	BioPro, Inc.
Sep 9, 2025	Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 S...	The device either indicated a failure of the piston ventilator before use or suffered a failure o...	Class I	Draeger, Inc.
Sep 9, 2025	Ashvins variant HEYEX 2 / HEYEX PACS. Software Version: Version 2.6.0 (Build ...	Potential that the measured value may be smaller than the actual area.	Class II	MedicalCommunications GmbH
Sep 9, 2025	NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I	Fluctuations may be more likely to occur if the total flow through the device sensor (used by the...	Class I	NOXBOX LTD
Sep 8, 2025	ICU Medical ChemoLock Universal Vented Vial Spike REF: CL-70	Port weld of drug transfer device may separate or break during use and potentially result in a l...	Class II	ICU Medical, Inc.
Sep 8, 2025	ICU Medical ChemoLock Vented Vial Spike, 13mm REF: CL-72	Port weld of drug transfer device may separate or break during use and potentially result in a l...	Class II	ICU Medical, Inc.
Sep 8, 2025	ICU Medical 60" (152 cm) Appx 1.2 ml, Ext Set, Smallbore w/ChemoLock Port, C...	Port weld of drug transfer device may separate or break during use and potentially result in a l...	Class II	ICU Medical, Inc.
Sep 8, 2025	ChemoLock Bag Spike, 01 units REF: CL-10-10	Port weld of drug transfer device may separate or break during use and potentially result in a l...	Class II	ICU Medical, Inc.
Sep 8, 2025	ICU Medical ChemoLock Vented Vial Spike, 20mm REF: CL-70S	Port weld of drug transfer device may separate or break during use and potentially result in a l...	Class II	ICU Medical, Inc.
Sep 8, 2025	ICU Medical ChemoLock Bag Spike with Clave Additive Port REF: CL3940	Port weld of drug transfer device may separate or break during use and potentially result in a l...	Class II	ICU Medical, Inc.
Sep 8, 2025	ICU Medical 7.5" (19 cm) Appx 1.5 ml, Ext Set w/ChemoLock" Port, Clamp, Grad...	Port weld of drug transfer device may separate or break during use and potentially result in a l...	Class II	ICU Medical, Inc.
Sep 8, 2025	ICU Medical Oncology Kit w/31" (79 cm) 20 Drop Admin Set w/Integrated ChemoL...	Port weld of drug transfer device may separate or break during use and potentially result in a l...	Class II	ICU Medical, Inc.
Sep 8, 2025	ICU Medical ChemoLock w/Mini Bag Spike ¿ REF: C-17	Port weld of drug transfer device may separate or break during use and potentially result in a l...	Class II	ICU Medical, Inc.
Sep 8, 2025	ICU Medical 73" (185 cm) Appx 2.5 ml, Ext Set, Smallbore w/ChemoLock Port, C...	Port weld of drug transfer device may separate or break during use and potentially result in a l...	Class II	ICU Medical, Inc.
Sep 8, 2025	ICU Medical 6" (15 cm) Ext Set w/MicroClave" Clear, ChemoLock" Port, Y-Conne...	Port weld of drug transfer device may separate or break during use and potentially result in a l...	Class II	ICU Medical, Inc.

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.