Browse Device Recalls

4,545 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 4,545 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 4,545 FDA device recalls in CA.

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Date	Product	Reason	Class	Firm
Apr 21, 2023	Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 1895	TC-I tip clip sensor may produce readings outside the accuracy specification.	Class II	Masimo Corporation
Apr 21, 2023	Masimo RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 4053	TC-I tip clip sensor may produce readings outside the accuracy specification.	Class II	Masimo Corporation
Apr 21, 2023	Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503	TC-I tip clip sensor may produce readings outside the accuracy specification.	Class II	Masimo Corporation
Apr 6, 2023	Metal Tray, 178 x 135 x 37 mm, REF: 11580A; Metal Tray, 275 x 178 x 35 mm, R...	Metal sterilization trays used to encase and protect medical devices during sterilization have a ...	Class II	Karl Storz Endoscopy
Apr 5, 2023	Beckman Coulter Bicarbonate, REF: OSR6237, 4x50 mL	There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result...	Class II	Beckman Coulter Inc.
Apr 5, 2023	BD Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES (Med E...	Automated dispensing cabinet software is experiencing: 1) ES device download failure resulting in...	Class II	CareFusion 303, Inc.
Apr 5, 2023	BD Pyxis MedStation ES (Med ES Main), REF: 323; and BD Pyxis MedStation ES ...	Due to an automated dispensing cabinet software issue, when a medication single order contains mo...	Class II	CareFusion 303, Inc.
Apr 5, 2023	NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Servic...	Cybersecurity vulnerability concerning the software used for sequencing instruments.	Class II	Illumina, Inc.
Apr 5, 2023	KARL STORZ Radel Sterilization Trays, Models: 27717A, 27717B, 39301A, 39301C,...	Plastic sterilization trays used to encase and protect medical devices during sterilization have ...	Class II	Karl Storz Endoscopy
Apr 5, 2023	Beckman Coulter Bicarbonate, REF: OS6637, 4x173 mL	There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result...	Class II	Beckman Coulter Inc.
Apr 5, 2023	Beckman Coulter Bicarbonate, REF: OSR6137, 4x25 mL	There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result...	Class II	Beckman Coulter Inc.
Apr 5, 2023	MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS...	Cybersecurity vulnerability concerning the software used for sequencing instruments.	Class II	Illumina, Inc.
Mar 20, 2023	DERMLITE DL4W, REF: DL4W, Rx Only MD, CE	Incorrect labeling; Package labeling contains a different serial number then the serial number on...	Class II	DermLite LLC
Mar 2, 2023	SafeLight Fiber Optic Cable: Clear, 5MM X 10FT 3.05M, REF: 0233-050-100; Gray...	Fiber optic cables assembled with not enough epoxy on the proximal end, creating light output iss...	Class II	Stryker Corporation
Feb 27, 2023	RelieVR REF: RVX-2002, Rx Only. Virtual reality behavioral therapy device fo...	There is the potential for the program software to malfunction which will not allow it to move fo...	Class II	Appliedvr
Feb 21, 2023	Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Medium), RE...	Incorrect labeling; specifically, the product name, lot number and product code on the carton lab...	Class II	Biosense Webster, Inc.
Feb 21, 2023	Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), REF...	Incorrect labeling; specifically, the product name, lot number and product code on the carton lab...	Class II	Biosense Webster, Inc.
Feb 21, 2023	Neodent GM X 6mm Engaging Titanium Base, REF: 9007162	Engaging titanium base contains a dimensional condition that allows vertical movement of the tita...	Class II	Preat Corp
Feb 15, 2023	KLS Martin Battery Pack, REF: KLS BP 001, and KLS BP 040 (bulk case of 40), u...	Battery packs used in surgical procedures where a surgeon uses a powered screwdriver and a right-...	Class II	Pro-Dex Inc
Feb 14, 2023	BD Pyxis MedStation ES AUX, REF 324	Drawer and/or door failures that may lead to a delay in access to medications. The following thre...	Class II	CareFusion 303, Inc.
Feb 14, 2023	BD Pyxis MedStation 4000 AUX, REF 306	Drawer and/or door failures that may lead to a delay in access to medications. The following thre...	Class II	CareFusion 303, Inc.
Feb 14, 2023	BD Pyxis MedStation ES (Med ES Main), REF 323	Drawer and/or door failures that may lead to a delay in access to medications. The following thre...	Class II	CareFusion 303, Inc.
Feb 14, 2023	BD Pyxis MedStation 4000 Main, REF 303	Drawer and/or door failures that may lead to a delay in access to medications. The following thre...	Class II	CareFusion 303, Inc.
Feb 14, 2023	BD Pyxis MedStation ES AUX Tower REF 343 BD Pyxis " MedStation 4000 AUX To...	Due to an increase in complaints of door latch assembly failures that may cause the doors to be l...	Class II	CareFusion 303, Inc.
Feb 14, 2023	BD Pyxis Anesthesia ES System (PAS ES), REF: 327; BP Pyxis MedStation ES (Med...	Automated dispensing cabinet drawer firmware may have inadvertently been downgraded to an earlier...	Class II	CareFusion 303, Inc.
Feb 14, 2023	Edward Lifesciences, REF 777F8, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermo...	There is a potential that the distal end of the catheter may be bent beyond its intended curvatur...	Class II	Edwards Lifesciences, LLC
Feb 14, 2023	BD Pyxis Med 4000 Auxiliary (AUX), REF 314	Drawer and/or door failures that may lead to a delay in access to medications. The following thre...	Class II	CareFusion 303, Inc.
Feb 14, 2023	Edward Lifesciences, REF 774F75, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Therm...	There is a potential that the distal end of the catheter may be bent beyond its intended curvatur...	Class II	Edwards Lifesciences, LLC
Feb 14, 2023	BD Pyxis Med ES Auxiliary (AUX), REF 343	Drawer and/or door failures that may lead to a delay in access to medications. The following thre...	Class II	CareFusion 303, Inc.
Feb 14, 2023	KLS martin Group KLS E-COUPLING ADAPTER REF PDEC-1000-2 E-Coupling Adapter...	Incorrect Unique Device Identifier/GTIN code was used on product.	Class II	Pro-Dex Inc
Feb 13, 2023	FreeStyle Libre Reader, REF: 71525-01, 71701-01, 71739-01 a component of the ...	Lithium-ion batteries in glucose monitoring system readers may swell, overheat, or pose fire haza...	Class I	Abbott Diabetes Care, Inc.
Feb 13, 2023	FreeStyle Libre Reader, REF: 71936-01, 71937-01, 71938-01 a component of the ...	Lithium-ion batteries in glucose monitoring system readers may swell, overheat, or pose fire haza...	Class I	Abbott Diabetes Care, Inc.
Feb 13, 2023	FreeStyle Libre Reader, REF: 71951-01, 71952-01, 71953-01 a component of the ...	Lithium-ion batteries in glucose monitoring system readers may swell, overheat, or pose fire haza...	Class I	Abbott Diabetes Care, Inc.
Feb 10, 2023	da Vinci Xi Surgical System Model IS4000 da Vinci X Surgical System Model ...	Due to Universal Surgical Manipulator (USM) instrument carriage being loose as a result of the li...	Class II	Intuitive Surgical, Inc.
Feb 9, 2023	FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when use...	If using affected glucose monitoring app on Android 13 Operating System, extended periods of sign...	Class II	Abbott Diabetes Care, Inc.
Feb 1, 2023	PREAT NOBIL GRIP, product numbers 0102000 and 01202000-3 (3 pack), 5-ml vials...	Product is labeled with an incorrect expiration date.	Class III	Preat Corp
Jan 30, 2023	Simplexa Flu A/B & RSV Direct Gen II, REF: MOL2655; including Reaction Mix RE...	Direct amplification Discs , used with COVID-19 and Flu A/B & RSV assays, may leak and cause cont...	Class II	DiaSorin Molecular LLC
Jan 30, 2023	Simplexa COVID-19 Direct, REF: MOL4150; including Reaction Mix, REF: MOL4150;...	Direct amplification Discs , used with COVID-19 and Flu A/B & RSV assays, may leak and cause cont...	Class II	DiaSorin Molecular LLC
Jan 24, 2023	Outset Tablo Model Numbers (REF): PN-0006000 PN-0007001 Tablo is a ne...	An observed trend of high conductivity dialysate alarms in a hemodialysis system as a result of i...	Class II	Outset Medical, Inc.
Jan 24, 2023	Patient Side Cart, REF: 380620, with instrument arms, used as part of the da ...	Preventative maintenance data was used to identify instrument Arms, part of surgical systems, tha...	Class II	Intuitive Surgical, Inc.
Jan 24, 2023	Alaris PC Unit 8015 utilizing 802.11 b/g or 802.11 a/b/g wireless network car...	Infusion pump PCs with specific software/network cards/IP addresses can have network/wireless con...	Class II	CareFusion 303, Inc.
Jan 16, 2023	Irvine Scientific Oil for Embryo Culture (Light Mineral Oil) REF Catalog # 9305	Due to the detection of oil toxicity in several lots of Oil for Embryo Culture products.	Class II	Fujifilm Irvine Scientific, Inc.
Dec 22, 2022	RipCord Syndesmosis Button, REF: STA001K	Overly aggressive tension on the pull suture, while passing the medial button through a bone/soft...	Class II	TriMed Inc.
Dec 16, 2022	Lucid TCD 2.0 System, Model: NA-LUCM1. Transcranial Ultrasound System	Transcranial Doppler/ultrasound system tablet has a faulty hard drive, which will cause the syste...	Class II	NovaSignal Corp.
Dec 16, 2022	NovaGuide Intelligent Ultrasound System, Model: NA-RBTSYS1. Comprised of Nova...	Transcranial Doppler/ultrasound system tablet has a faulty hard drive, which will cause the syste...	Class II	NovaSignal Corp.
Dec 12, 2022	BD Pyxis MedBank System - Product Label/labeling pending	Due to customer complaints related to the MedBank software which may indicate that a different me...	Class II	CareFusion 303, Inc.
Dec 7, 2022	Single-Use Packs, REF: OPO80	Weld protrusion/physical gap between the housing and phaco pack cover, may exceed design specific...	Class II	Johnson & Johnson Surgical Vision, Inc.
Dec 7, 2022	Veritas Advanced Infusion Packs, REF: VRT-AI	Weld protrusion/physical gap between the housing and phaco pack cover, may exceed design specific...	Class II	Johnson & Johnson Surgical Vision, Inc.
Dec 7, 2022	FUSION Dual Pump Packs, REF: OPO73	Weld protrusion/physical gap between the housing and phaco pack cover, may exceed design specific...	Class II	Johnson & Johnson Surgical Vision, Inc.
Dec 5, 2022	Invisalign Express 10 REF 8512 Invisalign System Comprehensive REF 9000 ...	3D orthodontic planning software has a defect that leads to an issue where incorrect number of al...	Class II	Align Technology 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.