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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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DateProductReasonClassFirm
Jun 14, 2021 Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF... Not properly sterilized, because the outer pouch seal on the Tyvek header was sealed closely to t... Class II Arthrex, Inc.
Jun 10, 2021 Lingen Disposable Virus Sampling Kit, Item MTM-04, 40 tubes/box. No 510(k) clearance Class II Mercedes Medical, Inc.
Jun 10, 2021 Lingen SAMPLE Disposable Virus Sampling Kit pack, Item SAM ENI MTM-04, contai... No 510(k) clearance Class II Mercedes Medical, Inc.
Jun 9, 2021 Avanti¿+ Catheter Sheath Introducer - Product Usage: Is indicated for use in ... The product in the packaging is larger (both inner and outer diameter) than the labeling indicates. Class II Cordis Corporation
Jun 3, 2021 HeartWare HVAD Implant Kit, REF MCS1705PU Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... Class I Heartware, Inc.
Jun 3, 2021 HeartWare HVAD Driveline Extension Cable, REF 100US Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... Class I Heartware, Inc.
Jun 3, 2021 HeartWare HVAD Implant Kit, REF 1104JP Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... Class I Heartware, Inc.
Jun 3, 2021 HeartWare HVAD Pump Implant Kit, REF 1104 Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... Class I Heartware, Inc.
Jun 3, 2021 HeartWare HVAD Pump Implant Kit, REF 1103 Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... Class I Heartware, Inc.
Jun 3, 2021 HeartWare HVAD Driveline Extension Cable, REF 100 Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... Class I Heartware, Inc.
Jun 3, 2021 HeartWare HVAD Pump Accessories, REF MCS1753AK Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... Class I Heartware, Inc.
Jun 3, 2021 HeartWare HVAD Outflow Graft, REF MCS1725OG Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... Class I Heartware, Inc.
Jun 3, 2021 HeartWare HVAD Pump Implant Kit, REF 1153 Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... Class I Heartware, Inc.
Jun 3, 2021 HeartWare HVAD Pump Implant Kit, REF 1125 Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... Class I Heartware, Inc.
May 28, 2021 HeartWare, HVAD Pump Implant Kit, REF MCS1705PU - Product Usage: indicated fo... The pump has an impeller with a shroud height that did not meet the lower control limit. Class II Heartware, Inc.
May 11, 2021 Humeral Augmented Tray (HAT) trials that are components of KIT-321HAT. Each... The HAT trial contains a retaining ring that has shown the potential to disengage during use. Class II Exactech, Inc.
May 6, 2021 ACUVUE VITA soft (hydrophilic) contact lens (spherical) for daily wear. Base... Potential that a limited number of individual contact lens packages have an incomplete packaging ... Class II Johnson & Johnson Vision Care, Inc.
Apr 1, 2021 Scooter Seat baseplate pin has broken in the field. Class II Merits Holdings Co. dba Merits Health Products,...
Apr 1, 2021 Power Wheelchair Seat baseplate pin has broken in the field. Class II Merits Holdings Co. dba Merits Health Products,...
Mar 31, 2021 SoftCytogenetics Software is given wrong results going out to HIS on test that had reruns. Class II Soft Computer Consultants, Inc.
Mar 31, 2021 SoftGenomics version 4.1.15.6 SoftGenomics is a laboratory workflow and in... Software showing wrong results reported, PDF not match HIS. Class II Soft Computer Consultants, Inc.
Mar 11, 2021 Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Product Usage: use ... It was discovered that five AR-13200ST-15.0 parts were processed as AR-13200T-15.0 parts. Class II Arthrex, Inc.
Mar 10, 2021 AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: in... Potential for open seal on sterile product Class II Oscor, Inc.
Feb 26, 2021 Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanie... Medtronic HeartWare HVAD System Instructions for Use (IFU) and Patient Manual (PM) updates regard... Class I Heartware, Inc.
Feb 26, 2021 Medtronic HVAD Packaged Monitor, Model Numbers: 1500, 1500AU, 1500DE, 1510US... There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cable... Class I Heartware, Inc.
Feb 26, 2021 Medtronic HVAD Alarm Adapter, Product Number: 1450 There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cable... Class I Heartware, Inc.
Feb 26, 2021 Power Supply: 1. Medtronic HVAD Controller AC Adapter, Product Numbers: 142... There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cable... Class I Heartware, Inc.
Feb 26, 2021 Medtronic HVAD Monitor Data Cable, Product Number: 1575 There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cable... Class I Heartware, Inc.
Feb 26, 2021 Medtronic HVAD Battery, Product Number: 1650, 1650CA-CLIN, 1650DE There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cable... Class I Heartware, Inc.
Feb 26, 2021 Medtronic HVAD Controller, Product Numbers: 1400, 1401, 1401AU, 1401BR, 1401... There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cable... Class I Heartware, Inc.
Feb 26, 2021 Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanie... IFU and Patient Manual updated to describe Expected Alarm Duration. The Instructions for Use (IF... Class II Heartware, Inc.
Feb 26, 2021 Instructions for Use and Patient Manual for HeartWare HVAD System. Accompani... IFU and Patient Manual updated to describe HVAD Controller Connection Verification. The labeling ... Class II Heartware, Inc.
Feb 24, 2021 Drill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of fo... The color indicator on the proximal end of the shaft of the AR-8770-02 is the incorrect color. Class II Arthrex, Inc.
Feb 16, 2021 EXTREME H2O 59% (hioxifilcon A) spherical soft contact lens for daily wear - ... Contact lenses may be mislabeled with the incorrect lens power. Class II Clerio Vision
Feb 11, 2021 PRECISE PRO RX CAROTID STENT implant system, Product Codes: PC0520RXC, PC053... Distal tip may become separated from the lumen wire in specific lots. Class I Cordis Corporation
Feb 1, 2021 HNM Disposable Bipolar Ablators - Product Usage: intended to be used for cutt... There can be a potential breach of the sterile packaging barrier due to the development of pinhol... Class II Bovie Medical Corporation
Feb 1, 2021 Velocity Disposable Bipolar Ablators - Product Usage: intended to be used for... There can be a potential breach of the sterile packaging barrier due to the development of pinhol... Class II Bovie Medical Corporation
Feb 1, 2021 ConMed Disposable Bipolar Ablators - Product Usage: intended to be used for c... There can be a potential breach of the sterile packaging barrier due to the development of pinhol... Class II Bovie Medical Corporation
Jan 19, 2021 AntIbody to SARS-CoV-2 - Product Usage: (Colloidal Gold) for IgG/IgM Diagnost... Distributed COVID test kits without emergency use authorization. Class II Sky Medical Supplies and Equipments LLC
Dec 10, 2020 Clerio Vision, extreme H2O monthly, MED, DIA 14.0 PWR -2.25, UPC 675506803334... One lot of contact lenses labeled as BC MED, DIA 14.0 PWR -2.25 contained BC MED, DIA 14.0, PWR -... Class II Clerio Vision
Nov 19, 2020 Medtronic HVAD Pump Implant Kits, labeled as: a. PUMP 1103, b. PUMP 1104, ... Pumps manufactured with impellers from a subset of lots from a single supplier are failing to ini... Class I Heartware, Inc.
Nov 10, 2020 PROKERA Slim, non-sterile - Product Usage: Biologic corneal bandage. Potential exposure of product to microbial contamination. Class II TissueTech, Inc.
Nov 10, 2020 PROKERA, non-sterile - Product Usage: Biologic corneal bandage. Potential exposure of product to microbial contamination. Class II TissueTech, Inc.
Nov 10, 2020 PROKERA Plus, non-sterile - Product Usage: Biologic corneal bandage. Potential exposure of product to microbial contamination. Class II TissueTech, Inc.
Nov 9, 2020 Equinoxe Humeral Stem, Primary, Press Fit, 11mm Potential for incorrect Instructions For Use (IFU) included with an Equinoxe Humeral Stem, Primar... Class II Exactech, Inc.
Nov 7, 2020 MX60ET (enhanced enVista Toric) enVista¿ One-Piece Hydrophobic Acrylic Toric ... Product may be missing toric axis marks. Class II Bausch & Lomb Surgical, Inc.
Oct 30, 2020 DRW-0739-01:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left); ac... The LRUL and LLUR posterior chairside splints and the LLUR anterior chairside splints may be misl... Class II Neocis, Inc.
Oct 23, 2020 Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Softw... Stryker has discovered a characterization issue associated with the Mako Integrated Cutting Syste... Class II Mako Surgical Corporation
Oct 6, 2020 Catalog 314-13-33, Equinoxe Cage Glenoid, Posterior Augment, Right, Medium The product may be mislabeled. Class II Exactech, Inc.
Oct 6, 2020 Catalog 314-13-23, Equinoxe Cage Glenoid, Posterior Augment, Left, Medium The product may be mislabeled. Class II Exactech, 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.