Browse Device Recalls
39,969 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 39,969 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 39,969 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 4, 2023 | Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality contr... | Delay in reporting results due to Quality Controls running high outside of range. Target value a... | Class III | Randox Laboratories Ltd. |
| May 4, 2023 | Betta Link LG Reusable Fishmouth Guide-Intended for use in soft tissue to bon... | Drill guides might bend when axial forces are applied by surgeon during procedure and result in p... | Class II | T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. |
| May 3, 2023 | Exeter V40 Trial Head, 26mm, -3, Catalog Number 6364-8-026 | The Exeter V40 Trial Head, catalog number 6364-8-026 (size 26mm, -3) may appear green, when it is... | Class II | Howmedica Osteonics Corp. |
| May 3, 2023 | NOxBOXi Nitric Oxide Delivery System, NOXBOX-I, REQNOXBOX-I, Nitric Oxide Del... | Device may experience malfunctions due to misalignment of the check valve in the manifold. If the... | Class I | NOXBOX LTD |
| May 3, 2023 | The TREO ABDOMINAL STENT-GRAFT SYSTEM (TREO) consists of four types of implan... | Potential for the incorrect size stent-graft than the printed carton label. | Class II | Bolton Medical Inc. |
| May 3, 2023 | MEDLINE THERAHONEY GEL, 100% LEPTOSPERMUM SCOPARIUM HONEY, a) REF MNK0005, b)... | Medline issued a recall on TheraHoney Wound Gel due to the manufacturer notifying Medline of a st... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 2, 2023 | Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Insert, Par... | Recent complaint data indicates that the revision rate may be trending higher than corresponding ... | Class II | Smith & Nephew, Inc. |
| May 2, 2023 | Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spif... | Packaging for a serrated blade applicator kit (12 Sample) may contain a serrated blade applicator... | Class II | Helena Laboratories, Corp. |
| May 2, 2023 | V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring Syste... | The sensors may experience an out-of-box failure because after recalibration, the sensors stayed ... | Class II | SenTec AG |
| May 2, 2023 | Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy sa... | The inner needle of the Sertera device is either detaching or discharging and may cause delay in ... | Class II | Hologic, Inc |
| May 2, 2023 | LEGACY SMARTBASE, NE 3.0D 1MML, REF: 8730-81NE; LEGACY SMARTBASE, NE 3.0D 2M... | Non-engaging abutments were distributed without FDA clearance; the performance characteristics ha... | Class II | Implant Direct Sybron Manufacturing LLC |
| May 2, 2023 | Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Tray, Part ... | Recent complaint data indicates that the revision rate may be trending higher than corresponding ... | Class II | Smith & Nephew, Inc. |
| May 2, 2023 | Smith&Nephew ENGAGE Cementless Partial Knee System, Porous Femoral components... | Recent complaint data indicates that the revision rate may be trending higher than corresponding ... | Class II | Smith & Nephew, Inc. |
| May 2, 2023 | Smith&Nephew ENGAGE Cementless Partial Knee System, Tibial Anchor Stem, Part ... | Recent complaint data indicates that the revision rate may be trending higher than corresponding ... | Class II | Smith & Nephew, Inc. |
| May 1, 2023 | EliA GliadinDP IgG Well in the Phadia 2500EE instrument (Material Number 1241... | Higher reported results when running EliA GliadinDP IgG Well on the instruments Phadia 2500EE com... | Class II | Phadia US Inc |
| May 1, 2023 | Trilogy Evo O2 and LifeVent EVO2, Model Numbers DS2100X11B, IN2100X15B, IN210... | Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion... | Class I | Philips Respironics, Inc. |
| May 1, 2023 | Phadia 2500EE instrument -Intended for the in vitro semi-quantitative measure... | Higher reported results when running EliA GliadinDP IgG Well on the instruments Phadia 2500EE com... | Class II | Phadia US Inc |
| May 1, 2023 | Trilogy Evo Universal Ventilator, Model Number DS2000X11B | The Trilogy Evo Universal ventilator provides continuous or intermittent positive pressure ventil... | Class I | Philips Respironics, Inc. |
| May 1, 2023 | Trilogy Evo, Garbin Evo, and Aeris EVO, Model Numbers DS2110X11B, IN2110X15B,... | Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion... | Class I | Philips Respironics, Inc. |
| May 1, 2023 | Trilogy Evo O2 EV300, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA220... | Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion... | Class I | Philips Respironics, Inc. |
| May 1, 2023 | BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B, 30 Single Use ... | IFU- Instructions for Use (IFU) package insert and both the IFU packaged with the test kit and th... | Class II | Becton Dickinson & Co. |
| Apr 28, 2023 | QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PC... | Faulty cartridges in the lot could result in false test results. | Class II | Qiagen Sciences LLC |
| Apr 28, 2023 | Teleflex HORIZON Microclip Titanium Ligating Clips w/tape, REF 005200; for us... | Teleflex LLC is initiating this voluntary field corrective action because the clip cartridges for... | Class II | TELEFLEX LLC |
| Apr 27, 2023 | Intelli-C, Right side suspended Tabletop, REF: 03400000 | There is a potential that the drive shaft in the detector up/down (IDE) movement of the X-Ray mac... | Class II | NRT X-RAY A/S |
| Apr 27, 2023 | Intelli-C, Left side suspended Tabletop, REF: 03400010 | There is a potential that the drive shaft in the detector up/down (IDE) movement of the X-Ray mac... | Class II | NRT X-RAY A/S |
| Apr 26, 2023 | HeartSine, REF: PAD-PAK-01, PAD-PAK-03 AND PAD-PAK-03j, CE0123 sold separate... | Single use battery and electrode cartridge may be rendered inoperable due to depleted battery cel... | Class II | HeartSine Technologies Ltd |
| Apr 26, 2023 | MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Speci... | The wrong tibia guide was included intended for a different patient case. | Class II | Materialise N.V. |
| Apr 25, 2023 | Incisive CT Plus-Computed Tomography X-Ray System Model: 728149 | Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Inci... | Class II | Philips North America |
| Apr 25, 2023 | Incisive CT Power (China)-Computed Tomography X-Ray System Model: 728148 | Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Inci... | Class II | Philips North America |
| Apr 25, 2023 | Ventralight ST 4" x 6" Ellipse with Echo PS Catalog Number: 5955460 | Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral... | Class II | Davol, Inc. |
| Apr 25, 2023 | Incisive CT-Computed Tomography X-Ray System Model: 728143 | Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Inci... | Class II | Philips North America |
| Apr 25, 2023 | Ventralight ST 4.5" Circle with Echo PS- A low profile, bioresorbable, coated... | Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral... | Class II | Davol, Inc. |
| Apr 25, 2023 | Incisive CT for Brazil SKD-Computed Tomography X-Ray System Model: 728146 | Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Inci... | Class II | Philips North America |
| Apr 25, 2023 | Ventralight ST w EchoPS 4"x6" Ellipse- A low profile, bioresorbable, coated, ... | Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral... | Class II | Davol, Inc. |
| Apr 25, 2023 | SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample c... | Fails Post-Sterilization Sterile Swabs Cantilever (Bend) Testing and may be more susceptible to b... | Class II | LumiraDx |
| Apr 25, 2023 | FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-011... | The firm has identified an increased risk of obtaining false positive Cryptosporidium results fro... | Class II | BioFire Diagnostics, LLC |
| Apr 25, 2023 | Ventralight ST w Echo PS 4.5" Circle A low profile, bioresorbable, coated, ... | Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral... | Class II | Davol, Inc. |
| Apr 25, 2023 | LINK SymphoKnee System L-Shaped Femoral Augment, Medial-Right/Lateral-Left, S... | Contains the incorrect implant in the packaging. The packaging incorrectly contains the opposite ... | Class II | Linkbio Corp. |
| Apr 24, 2023 | AVNS ambIT System - PIB/PCA W 5in Cath, Product Code: 220507 | Some of the ambIT kits were potentially distributed without an air in-line filter. | Class II | Avanos Medical, Inc. |
| Apr 24, 2023 | Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only | pipettes packaged in Strep A test may fail to dispense an adequate sample volume which could resu... | Class II | Cepheid |
| Apr 24, 2023 | Aligned Medical Solutions Spine Pack, REF: AMS4599(C, containing P 2 Cover ... | Light handle covers may separate from the light handle (detach and fall off) during use, this cou... | Class II | Windstone Medical Packaging, Inc. |
| Apr 24, 2023 | Aligned Medical Solutions Minor Hand Pack, REF: AMS6539E, containing P 2 Co... | Light handle covers may separate from the light handle (detach and fall off) during use, this cou... | Class II | Windstone Medical Packaging, Inc. |
| Apr 24, 2023 | Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD, | pipettes packaged in Strep A test may fail to dispense an adequate sample volume which could resu... | Class II | Cepheid |
| Apr 24, 2023 | SMMT ambIT Reusable Program - Luer Cass, Product Code: 220568 | Some of the ambIT kits were potentially distributed without an air in-line filter. | Class II | Avanos Medical, Inc. |
| Apr 24, 2023 | ambIT Cassette Filter Male Luer, Product Code: 220266 | Some of the ambIT kits were potentially distributed without an air in-line filter. | Class II | Avanos Medical, Inc. |
| Apr 24, 2023 | Aligned Medical Solutions Hand Pack, REF: AmS4601E, containing P 2 Cover Li... | Light handle covers may separate from the light handle (detach and fall off) during use, this cou... | Class II | Windstone Medical Packaging, Inc. |
| Apr 24, 2023 | SMMT ambIT Kit Basic Filter Luer Cass, Product Code: 220537 | Some of the ambIT kits were potentially distributed without an air in-line filter. | Class II | Avanos Medical, Inc. |
| Apr 24, 2023 | Alinity i Anti-TPO Reagent Kit, List Number 09P3521 | Due to a manufacturing fill volume error, Alinity i Anti-TPO Reagent contains a marginally lower ... | Class III | Abbott Ireland Limited |
| Apr 24, 2023 | AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509 | Some of the ambIT kits were potentially distributed without an air in-line filter. | Class II | Avanos Medical, Inc. |
| Apr 22, 2023 | Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992209 Version... | There is a potential that valve assemblies will not open. preventing fluid from draining. | Class II | Merit Medical Systems, 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.