Browse Device Recalls

4,538 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 4,538 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 4,538 FDA device recalls in CA.

Date	Product	Reason	Class	Firm
Sep 8, 2025	ICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33	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/2 ChemoLock", 13mm Closed Vial Spike w/ChemoLock"...	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 Port REF: CL2100	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 Clave Bag Spike w/ChemoLock Port REF: CL2150	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 Graduated Connector w/ChemoLock Port REF: CL3900	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 Vial Spike, 20mm REF: CL-80S	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 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/Integrated ChemoLoc...	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 Transfer Kit w/ChemoClave and ChemoLock Port; Spiros w/...	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 ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA13...	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 30" (76 cm) Appx 3.3 mL, Admin Set w/20 Drop Integrated ChemoLoc...	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 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port R...	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 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: 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 Chemo Lock Universal Vented Vial Spike REF: CL-70-10	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, 20 Units ¿ REF: 011-CL-70S-20	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 Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34	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 ChemosafeLock Connecter REF: KL-FNU3	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" Port, Bulk, Non-Sterile REF: CL2100-NS	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 Port w/Spiros, Red Cap REF: CL-35	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 Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5	Port weld of drug transfer device may separate or break during use and potentially result in a l...	Class II	ICU Medical, Inc.
Sep 5, 2025	Flow Re-Direction Endoluminal Devices: FRED 27, REF: FRED5019, FRED5029, FRED...	Flow diverter may have a manufacturing issue related to the tantalum length and/or tantalum attac...	Class II	MICROVENTION INC.
Sep 3, 2025	SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagno...	Specific SYNCHRON Systems Modular Chemistry Phosphorus (PHOSm REF 467868) reagent lots may fail c...	Class II	Beckman Coulter Inc.
Sep 2, 2025	Tribio Implant 7.5mm x 40mm REF M80 SB008 UDI code: (01) 00816125023653(10) ...	Due to incorrect product label (Incorrect product name identified on outer packaging).	Class II	Berkeley Advanced Biomaterials, LLC
Sep 2, 2025	This device is a digital radiography/fluoroscopy system used in a diagnostic ...	It has been found that when SPOT Fluoro is first turned on, the default ROI is selected and the c...	Class II	Canon Medical System, USA, INC.
Aug 29, 2025	The product is a handheld ultraviolet-C germicidal wand and contains a narrow...	The subject product emits unsafe level of UVC radiation (i.e., the product reaches the exposure l...	Class II	BigTree Sales Inc.
Aug 28, 2025	Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dex...	A software defect in version v1.15.0 of the G6 Android app can cause the app to terminate unexpec...	Class I	Dexcom, Inc.
Aug 13, 2025	UniCel DxH 600 COULTER Cellular Analysis System, configured with the Led HGB ...	Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (H...	Class II	Beckman Coulter Inc.
Aug 13, 2025	UniCel DxH 690T COULTER Cellular Analysis System, configured with the Led HGB...	Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (H...	Class II	Beckman Coulter Inc.
Aug 13, 2025	UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB ...	Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (H...	Class II	Beckman Coulter Inc.
Aug 13, 2025	UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB ...	Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (H...	Class II	Beckman Coulter Inc.
Aug 6, 2025	Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 0733294000...	As a result of Post-Market half-time stability testing, false negative test result was observed f...	Class II	Cepheid
Aug 6, 2025	Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System	Inserter, used as part of a system with an intervertebral body fusion device, may contribute to d...	Class II	SEASPINE ORTHOPEDICS CORPORATION
Aug 5, 2025	t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology,...	A software defect in versions 7.9.0.1 and 7.10.1 of the pump software for Tandem t:slim X2 and ve...	Class II	Tandem Diabetes Care, Inc.
Aug 4, 2025	DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Modul...	On a clinical analyzer, when ordering a Clinical Chemistry (CC) combination test simultaneously w...	Class II	Beckman Coulter Inc.
Jul 25, 2025	ZAP-X Radiosurgery System, Model: 300150	If the radiosurgery system triggers a proximity error message during a long gantry move (greater-...	Class II	Zap Surgical Systems
Jul 24, 2025	Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dex...	The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iO...	Class I	Dexcom, Inc.
Jul 24, 2025	Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: D...	The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iO...	Class I	Dexcom, Inc.
Jul 24, 2025	Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dex...	The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iO...	Class I	Dexcom, Inc.
Jul 24, 2025	Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: D...	The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iO...	Class I	Dexcom, Inc.
Jul 24, 2025	Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dex...	The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iO...	Class I	Dexcom, Inc.
Jul 22, 2025	RefleXion X1 Model RXM1000 UDI Codes: (01)00860003983812(11)230504(21)X1100...	Due to incorrect software configuration that potentially allows more than two (2) fractions withi...	Class II	Reflexion Medical, Inc.
Jul 21, 2025	Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF:...	Insulin pumps manufactured with speakers from Revision A and B may malfunction ("Malfunction 16")...	Class I	Tandem Diabetes Care, Inc.
Jul 10, 2025	Description/REF: BD PYXIS MEDBANK MINI 1FH-1FM/169-137, BD PYXIS MEDBANK MI...	Reports of delayed access to medication in automated dispensing cabinets because of the override/...	Class III	CareFusion 303, Inc.
Jul 8, 2025	BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions	Infusion pump module used with compatible pump infusion sets may perform outside the establishe...	Class I	CareFusion 303, Inc.
Jul 8, 2025	BD Alaris Pump Infusion Sets REF: 10013186, BD Alaris Pump Infusion Set, B...	Infusion pump module used with compatible pump infusion sets may perform outside the establishe...	Class I	CareFusion 303, Inc.
Jul 8, 2025	BD Trucount Controls, 30 Test - REF: 340335	Control kits contain incorrect standard deviation (SD) values for the low and high control beads ...	Class II	Becton, Dickinson and Company, BD Bio Sciences
Jul 8, 2025	BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD	Control kits contain incorrect standard deviation (SD) values for the low and high control beads ...	Class II	Becton, Dickinson and Company, BD Bio Sciences
Jul 8, 2025	Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Numb...	Wire break(s) have occurred in rechargeable deep brain stimulation implantable pulse generators, ...	Class II	Boston Scientific Neuromodulation Corporation
Jul 8, 2025	Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M36...	Resistance and difficulties could occur while closing the retaining clip locking mechanism, which...	Class II	Boston Scientific Neuromodulation Corporation
Jul 3, 2025	Orascoptic Superior Visualization Phantom Essential kit ( Nose pad, a screw...	Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.	Class II	Orascoptic Surgical Acuity
Jul 3, 2025	Orascoptic Superior Visualization Custom loupes configured with Phantom Frames	Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.	Class II	Orascoptic Surgical Acuity

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.