Browse Device Recalls

1,503 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,503 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 1,503 FDA device recalls in FL.

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Date	Product	Reason	Class	Firm
Dec 23, 2019	LemonPrep Tubes (MD0019-T) and Single use cups (MD0019-SUP)	Samples of 114gm tubes of Lemon Prep, collected during a Food and Drug Administration inspection ...	Class II	Carroll-Baccari, Inc.
Dec 17, 2019	Arthrex Fibulock Fibular Nail Instrument Set Reusable non-sterile instrument...	There is a potential for blockage of the Hub Attachment Tube.	Class II	Arthrex, Inc.
Dec 3, 2019	Exactech equinoxe PLATFORM FRACTURE, HUMERAL STEM, CEMENTED, Right, 6.5mm, RE...	Labels with incorrect translations were identified by Exactech is a distributor in the Netherland...	Class II	Exactech, Inc.
Dec 3, 2019	Exactech equinoxe PLATFORM FRACTURE, HUMERAL STEM, CEMENTED, Right, 10.5mm, R...	Labels with incorrect translations were identified by Exactech is a distributor in the Netherland...	Class II	Exactech, Inc.
Nov 13, 2019	Lamicel 20PK 3MM INTL Cervical dilator	Routine sterilization dose does not meet the required Sterility Assurance Level.	Class II	Medtronic Xomed, Inc.
Nov 13, 2019	Lamicel 20PK 5MM INTL	Routine sterilization dose does not meet the required Sterility Assurance Level.	Class II	Medtronic Xomed, Inc.
Nov 13, 2019	Lamicel 10PK 10MM INTL	Routine sterilization dose does not meet the required Sterility Assurance Level.	Class II	Medtronic Xomed, Inc.
Oct 7, 2019	UniCel DxH Slidemaker Stainer (DxH SMS) and UniCel DxH Slidemaker Stainer II ...	When the UniCel DxH Slidemaker Stainer and UniCel DxH Slidemaker Stainer II dispense probe is sli...	Class II	Beckman Coulter, Inc.
Oct 4, 2019	Cordis MAXI LD PTA Dilatation Catheter, for cardiovascular use.	Product was manufactured utilizing an expired inner body.	Class II	Cordis Corporation
Oct 4, 2019	Neocis Guidance System Fiducial Array - Product Usage: The Neocis Guidance Sy...	The Fiducial Array may mismatch their measurement files resulting in failed landmark check.	Class II	Neocis Inc.
Oct 2, 2019	2.4mm x 2.5 Fluted Pin Pouch; Catalog Number: 351-90-22; Orthopedic surgical...	Potential for the 2.4mm x 2.5 Fluted Pin Pouch to contain a single pin rather than four (4) as i...	Class II	Exactech, Inc.
Oct 1, 2019	Low Profile Screw, 4.5 x 20 mm The Low Profile ScrewTM, 4.5 x 20 mm, AR-85...	Screws provided in the device package are 6 mm longer than intended.	Class II	Arthrex, Inc.
Sep 10, 2019	Ergo 3.2mm K-wire - Product Usage: The devices is used assist the surgeon in ...	Potential for the wire to fracture at the threads and remain in the glenoid.	Class II	Exactech, Inc.
Sep 5, 2019	Lemon Prep: MD0019T - 4 oz tubes MD0019--SUP - Single Use Cups Skin prep...	Product has the potential to be contaminated with Burholderia cepacia.	Class II	Carroll-Baccari, Inc.
Sep 5, 2019	Pedia Prep: MD0033T - 4 oz tubes MD0033--SUP - Single Use Cups Skin pr...	Product has the potential to be contaminated with Burholderia cepacia.	Class II	Carroll-Baccari, Inc.
Jul 24, 2019	Threaded Offset Cup Impactor - Product Usage: To assist the surgeon in the im...	The threaded mechanism of the Threaded Offset Cup Impactor may be gritty and difficult to turn po...	Class II	Exactech, Inc.
Jun 24, 2019	TAPSYSTEM Model 2A, REF 8002A	There is a potential for an assembly error resulting in the battery wire being connected to the O...	Class III	Cardiocommand Inc.
May 31, 2019	CLEO Patient Monitor /Tranquility VS Patient Monitor	The CLEO & Tranquility VS Patient Monitors 510(k) indications for use in the United States did no...	Class II	Infinium Medical, Inc
May 10, 2019	CardioCommand, Inc. Transesophageal Cardiac Pacing and Recording System, Mode...	Possible corrosion of the battery contact(s).	Class III	Cardiocommand Inc.
May 8, 2019	Nasal Alar SpO2 Sensor, Adult/Pediatric SpO2 Sensor, Rx Only Product Usage...	These Instructions for Use has missing instructions related to the checking and changing of the a...	Class II	Xhale Assurance, Inc.
Apr 26, 2019	Inovo Single Luman Conserver Product Usage: This device is intended to re...	The pressure gauge (manometer) may dislodge from the threaded insertion/mount, creating a leak.	Class II	Inovo, Inc
Apr 26, 2019	Opteform Allograft Disc, 45mm x 5mm, 8cc, Catalog Number 600-03-45	The Opteform Disc-30mm, Opteform Disc-45mm, and Opteform Disc-90mm were potentially exposed to hi...	Class II	Exactech, Inc.
Apr 26, 2019	Opteform Allograft Disc, 90mm x 5mm, 22cc, Catalog Number 600-03-90	The Opteform Disc-30mm, Opteform Disc-45mm, and Opteform Disc-90mm were potentially exposed to hi...	Class II	Exactech, Inc.
Apr 26, 2019	Opteform Allograft Disc, 30mm 3mm, 2cc, Catalog Number 600-03-30	The Opteform Disc-30mm, Opteform Disc-45mm, and Opteform Disc-90mm were potentially exposed to hi...	Class II	Exactech, Inc.
Apr 25, 2019	2.7 Degree Straight Sagittal Saw attachment (Mako Total Knee Application and ...	The bearings of the saw attachments were ungreased.	Class II	Mako Surgical Corporation
Apr 25, 2019	2.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only)	The bearings of the saw attachments were ungreased.	Class II	Mako Surgical Corporation
Mar 13, 2019	Truliant Tibial Fit Tray Cemented SZ 3F / 3T, Catalog Number 02-022-45-3030 ...	2.5 Truliant Fit Trays were mismarked as 3	Class II	Exactech, Inc.
Mar 11, 2019	ACUVUE OASYS for ASTIGMATISM brand contact lenses, Base Curve 8.6 Refractive ...	One lot of ACUVUE OASYS¿ for ASTIGMATISM Brand Contact lenses has the potential for a limited num...	Class II	Johnson & Johnson Vision Care, Inc.
Feb 26, 2019	CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number ILDAT3 - Product ...	During manufacturing, the screw stop ledge was not made to specification and location within the ...	Class II	Biomet 3i, LLC
Feb 26, 2019	CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number IEDAN3 - Product Usage...	During manufacturing, the screw stop ledge was not made to specification and location within the ...	Class II	Biomet 3i, LLC
Feb 26, 2019	CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number IEDAT3 - Product ...	During manufacturing, the screw stop ledge was not made to specification and location within the ...	Class II	Biomet 3i, LLC
Feb 26, 2019	CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number IIAT3 - Product ...	During manufacturing, the screw stop ledge was not made to specification and location within the ...	Class II	Biomet 3i, LLC
Feb 26, 2019	CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number ILDAN3 - Product Usage...	During manufacturing, the screw stop ledge was not made to specification and location within the ...	Class II	Biomet 3i, LLC
Feb 7, 2019	Cordis Vista Brite Tip & Androit Guiding Catheters Product Usage: The gui...	Frayed pieces of the mounting card being inside the primary packaging.	Class III	Cordis Corporation
Jan 15, 2019	Proximal Humerus Plate, 8 holes, Right, REF MDS130108R - Product Usage: The P...	Right Proximal Humerus Plates. Product component parts MDS130108R, may be improperly identified a...	Class II	Miami Device Solutions, LLC.
Jan 14, 2019	Arthrex Burr, Oval, 12 Flute, 5.5 mm x 13 cm (AR-8550OBT) These devices ar...	Devices may generate excessive heat during use.	Class II	Arthrex, Inc.
Dec 10, 2018	ProSun V3 42 Xlc(160w)(10 minutes) tanning bed, Model 500. Labeled as the fo...	ProSun International LLC discovered discrepancies in their Quality Control Checklist documentatio...	Class II	ProSun International, LLC
Dec 10, 2018	ProSun Onyx 32 Sli Intensive (12 minutes) tanning bed, Model 32/1. Labeled a...	ProSun International LLC discovered discrepancies in their Quality Control Checklist documentatio...	Class II	ProSun International, LLC
Dec 5, 2018	Equinoxe Preserve Humeral Stem, 8mm Product Usage: The Equinoxe Preserve ...	Possibility that the Equinoxe Preserve Humeral Stem, 8mm, was inadvertently packaged with an Opt...	Class II	Exactech, Inc.
Nov 19, 2018	Arthrex Suture Anchor, Nano Corkscrew FT (consists of an anchor pre-loaded on...	Potentially lead to anchor breakage during insertion,	Class II	Arthrex, Inc.
Nov 19, 2018	Medtronic HeartWare Ventricular Assist HVAD System Battery Charger Model 1600...	HVAD Battery Charger units manufactured with wrong inductors.	Class II	Heartware, Inc.
Nov 5, 2018	enVista One Piece Hydrophobic Acrylic Intraocular lens - Is indicated for...	Cosmetic imperfections on the surface of some lenses.	Class II	Bausch & Lomb Surgical, Inc.
Nov 2, 2018	RadPRO(R) Mobile 40kW Digital X-Ray System - Model: SM-40HF-B-D-C Produ...	There is a potential for the RadPRO Mobile 40kW Digital X-Ray System Model SM-40HF-B-D-C to separ...	Class II	Virtual Imaging, Inc.
Nov 2, 2018	Ascom Telligence Nurse Call System	There is an issue that could cause the Telligence System Gateway II, NGGTWY2 H, to stop communica...	Class II	Ascom (US) Inc.
Oct 16, 2018	Family Wellness First Aid Sterile Gauze Pad 3 in x 3 in, 10 CT. White, ble...	Potential that gauze pads may not be fully sterilized	Class II	ASO, LLC
Sep 26, 2018	TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straig...	During the use of some TB - Temporary Bipolar Pacing Leads, featuring the 2mm unshrouded connecto...	Class I	Oscor, Inc.
Sep 24, 2018	Xper Flex Cardio Physiomonitoring System, Software version 1.6.0.0388	The Invasive Blood Pressure (IBP) numeric values will freeze on the display when any of the follo...	Class II	Invivo Corporation
Sep 13, 2018	3.2mm Proximal Reamer/Cannulated Drill provided as part of the Fibulock Fibul...	There is potential to break during use.	Class II	Arthrex, Inc.
Sep 5, 2018	Cordis POWERFLEX PRO PTA Dilatation Catheter - Product Usage: Is intended to ...	Product may not meet the internal manufacturing shaft subassembly burst strength specification (F...	Class II	Cordis Corporation
Aug 28, 2018	Heart Ware(TM) HVAD(TM) System Controller/Controller Kits, Model Numbers: 14...	Certain HVAD System Controller units may not meet the labeled standard for protection against wat...	Class II	Heartware, 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.