Browse Device Recalls
35,226 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 35,226 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 35,226 FDA device recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 8, 2026 | KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033, | A product error defect may cause incorrect bracket placement. | Class II | Klowen Braces |
| Jun 8, 2026 | Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R | Surgical dressing manufactured out of specification (greater thickness). | Class II | ConvaTec, Inc |
| Jun 8, 2026 | ARTIS icono ceiling. Model Number: 11328100. | Potential issue with the Display ceiling suspension (DCS Fix XL) that holds the monitor in place.... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 5, 2026 | Optima XR240amx, Mobile Digital Radiographic System | GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a co... | Class II | GE Medical Systems, LLC |
| Jun 5, 2026 | Optima XR220amx, Mobile Digital-Ready Radiographic System | GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a co... | Class II | GE Medical Systems, LLC |
| Jun 5, 2026 | Optima XR200amx, Mobile Digital-Ready Radiographic System | GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a co... | Class II | GE Medical Systems, LLC |
| Jun 5, 2026 | OmniTract Surgical Retractor System, which includes 633 of the firm s product... | The current Omni-Tract Surgical Retractor System IFU states a dry time of 30 minutes. Integra Lif... | Class II | Integra LifeSciences Corp. (NeuroSciences) |
| Jun 5, 2026 | Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXE... | Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to repla... | Class II | Olympus Corporation of the Americas |
| Jun 5, 2026 | Brand Name: Medela Product Name: ENFit ExSet Strl 60 2.0ml PV 1ct EN Model... | May contain incorrect connectors and will not attach or misconnect to ENFit connections and is th... | Class II | Medela Inc |
| Jun 5, 2026 | Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the fo... | Potential for device reset to default "NEW_DEVICE" state, which may lead to a to loss of device c... | Class II | Philips North America Llc |
| Jun 4, 2026 | Brand Name: Xhibit Product Name: Xhibit Central Station Model/Catalog Numbe... | Due to off-the-shelf display port component that has audio/video failures | Class II | Spacelabs Healthcare, Inc. |
| Jun 4, 2026 | VITEK 2 AST-N447 TEST KIT Product reference 424620 | Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with... | Class II | Biomerieux Inc |
| Jun 4, 2026 | MEDLINE 111 GRAVITY SET W/3 Needle Free Y-Sites REF DYNDTN0555 Catalog Numb... | Due to engineering sample labeled "Not for Human Use" being inadvertently shipped it the U.S. mar... | Class II | BD SWITZERLAND SARL |
| Jun 3, 2026 | Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT | Due to manufacturing issues, reperfusion catheters may fractures | Class II | Penumbra, Inc. |
| Jun 3, 2026 | GC Agar Base (150mm) 10/PK R04030; GC Agar Base (100mm) 10/PK R01460 | Reduced or no recovery of some strains of Neisseria gonorrhoeae. | Class II | Remel, Inc |
| Jun 2, 2026 | The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (Model VH-4000; UD... | Getinge identified that Vasoview Hemopro 2 devices from Lot 3000547797 were exposed to an out-of-... | Class II | Maquet Cardiovascular, LLC |
| Jun 1, 2026 | Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557 | Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications. | Class II | Carl Zeiss Meditec AG |
| May 29, 2026 | Emano Flow with software version v2.0.0 GS1 GTIN code: 199874903484 Emano... | Problem description/Reason for recall: During the period March 22, 2026, to May 29, 2026, recorde... | Class II | Emano Metrics, Inc. |
| May 28, 2026 | SeaSpine Polyaxial Head REF Number: 41-3010 | Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following... | Class II | SEASPINE ORTHOPEDICS CORPORATION |
| May 28, 2026 | Medline Convenience Kits: 1) OPEN HEART PEDS PACK, Model Number: DYNJ88569D;... | Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medt... | Class II | Medline Industries, LP |
| May 28, 2026 | Medline Convenience Kits: 1) OPEN HEART PEDS PACK, Model Number: DYNJ88569; ... | Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medt... | Class II | Medline Industries, LP |
| May 28, 2026 | Medline Convenience Kits: 1) ANESTHESIA KIT PEDS 90-LF, Model Number: DYNJAP... | Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medt... | Class II | Medline Industries, LP |
| May 28, 2026 | Medline Convenience kits containing recalled Swan-Ganz Catheters CV ANESTH... | Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of... | Class II | Medline Industries, LP |
| May 28, 2026 | Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEA... | Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of... | Class II | Medline Industries, LP |
| May 28, 2026 | Medline Convenience kits containing recalled Swan-Ganz Catheters CABG A CD... | Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of... | Class II | Medline Industries, LP |
| May 28, 2026 | Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEA... | Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of... | Class II | Medline Industries, LP |
| May 28, 2026 | Medline Convenience kits containing recalled Swan-Ganz Catheters CENTRAL A... | Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of... | Class II | Medline Industries, LP |
| May 28, 2026 | Medline Convenience kits containing recalled Swan-Ganz Catheters OPEN HEAR... | Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of... | Class II | Medline Industries, LP |
| May 28, 2026 | Medline Convenience kits containing recalled Swan-Ganz Catheters CARDIAC M... | Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of... | Class II | Medline Industries, LP |
| May 28, 2026 | Medline Convenience kits containing recalled Swan-Ganz Catheters KIT GERMA... | Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of... | Class II | Medline Industries, LP |
| May 28, 2026 | Acumed Hexalob Screw various sizes: REF Numbers: : 3070-27008 2.7mm x 8mm NL... | Due to manufacturing error, hexalobe screws used with wrist fixation system may break during use. | Class II | Acumed LLC |
| May 27, 2026 | MiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-1896 | A software anomaly can occur when the pump is paired with the Instinct sensor. Under certain circ... | Class II | Medtronic MiniMed, Inc. |
| May 27, 2026 | Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dex... | Certain lots of Dexcom G7 sensors originally designated as scrap and intended for destruction wer... | Class II | Dexcom, Inc. |
| May 27, 2026 | Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit, Catalog number 50460... | Some units of Aluminum Chloride Gel contain the package insert for Ferric Sulfate Gel. The incorr... | Class II | Inter-Med Llc |
| May 26, 2026 | Philips Avalon Fetal Monitor, FM 30 Part numberM2703A | Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulle... | Class II | Philips North America Llc |
| May 26, 2026 | Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A | Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulle... | Class II | Philips North America Llc |
| May 25, 2026 | Medtronic DLP One-Piece Pediatric Arterial Cannula, Product Number/CFN 77010;... | Medtronic received two complaints of loose foreign material confirmed as containing trace levels ... | Class II | Medtronic Perfusion Systems |
| May 25, 2026 | Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115; Cardio... | Medtronic received two complaints of loose foreign material confirmed as containing trace levels ... | Class II | Medtronic Perfusion Systems |
| May 22, 2026 | GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1006. Flexible,... | 10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm dia... | Class II | W L Gore & Associates, Inc. |
| May 22, 2026 | GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010. Flexible,... | 10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm dia... | Class II | W L Gore & Associates, Inc. |
| May 22, 2026 | Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw System | Pedicle screw system intended to provide immobilization/stabilization of spinal segments as adjun... | Class II | Innovasis, Inc |
| May 22, 2026 | IntelliCuff, Portable automatic cuff pressure controller REF: 951001 | Due to reported complaints, the cuff device may alarm with a "Cuff System Leakage" error. As a re... | Class II | Hamilton Medical AG |
| May 21, 2026 | GEM Premier 7000 with iQM3 Part Numbers: 00077407508 00077407510 000... | The active ingredient concentration in the lysing bag solution of specific GEM Premier 7000 with ... | Class II | Instrumentation Laboratory |
| May 21, 2026 | Brand Name: Medical Action Industries Product Name: Dialysis Change Tray Cl... | Convenience kits contain needle free access device that has an improper seal which may result in... | Class II | Medical Action Industries, Inc. 306 |
| May 21, 2026 | GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 000554075... | The active ingredient concentration in the lysing bag solution of specific GEM Premier 5000 lots ... | Class II | Instrumentation Laboratory |
| May 21, 2026 | Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain exp... | Flexible hysteroscopes indicated for use during diagnostic and operative hysteroscopic procedures... | Class II | Karl Storz Endoscopy |
| May 21, 2026 | Papablic Replacement Brush Heads. Model Number: Papablic18B | Potential for brush heads to break. | Class II | Papablic Inc |
| May 21, 2026 | Papablic Replacement Brush Heads. Model Number: PAPA317AA. | Potential for brush heads to break. | Class II | Papablic Inc |
| May 21, 2026 | Medline Convenience Kits: 1) L&D CONTINUOUS EPIDURAL TRAY, Model Number: PAI... | The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(... | Class II | Medline Industries, LP |
| May 21, 2026 | Medline Convenience Kits: 1) MULTIMED, 7FR, 20CM, 3L, CVC BUNDLE, Model Numb... | The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(... | Class II | Medline Industries, LP |
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.