Browse Device Recalls
39,885 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 39,885 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 39,885 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 10, 2026 | Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Int... | Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to lea... | Class I | Oscor Inc. |
| Jun 10, 2026 | ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) ... | In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on ... | Class II | ICU Medical, Inc. |
| Jun 10, 2026 | Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilatera... | Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M10... | Class II | Orthofix U.S. LLC |
| Jun 9, 2026 | Brand Name: Versius Surgical System US Product Name: Vesius Surgeon Console ... | Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersec... | Class II | CMR SURGICAL LIMITED |
| Jun 9, 2026 | Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet... | Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderat... | Class II | Zimmer Surgical Inc |
| Jun 9, 2026 | Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet... | Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderat... | Class II | Zimmer Surgical Inc |
| Jun 8, 2026 | STRYKER PKG., STRYKEFLOW SUCTION/IRRIGATOR PS, Catalog Number 0250070540 | There has been an increased amount in reported complaints consistently describing leaking from th... | Class II | Stryker Corporation |
| Jun 8, 2026 | STRYKER AHTO TUBE SET WITH TIP PACKAGING, Catalog Number 0250070620 | There has been an increased amount in reported complaints consistently describing leaking from th... | Class II | Stryker Corporation |
| Jun 8, 2026 | STRYKER PKG., SINGLE SPIKE TUBE SET, Catalog Number 0250070530 | There has been an increased amount in reported complaints consistently describing leaking from th... | Class II | Stryker Corporation |
| Jun 8, 2026 | HardyDisk AST Cefiderocol 30¿g (FDC30) REF Z9435 HardyDisk AST Cefideroc... | Due to incorrect cartridges include in affected products that there is the potential for false-su... | Class II | Hardy Diagnostics |
| Jun 8, 2026 | STRYKER AHTO TUBE SET PACKAGING, Catalog Number 0250070600 | There has been an increased amount in reported complaints consistently describing leaking from th... | Class II | Stryker Corporation |
| Jun 8, 2026 | STRYKER AHTO DUAL SPIKE TUBE SET PACKAGING, Catalog Number 0250070640 | There has been an increased amount in reported complaints consistently describing leaking from th... | Class II | Stryker Corporation |
| Jun 8, 2026 | AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Lami... | The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalli... | Class II | Windstone Medical Packaging, Inc. |
| Jun 8, 2026 | AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT ... | The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalli... | Class II | Windstone Medical Packaging, Inc. |
| Jun 8, 2026 | AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Neur... | The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalli... | Class II | Windstone Medical Packaging, Inc. |
| Jun 8, 2026 | AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT ... | The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalli... | Class II | Windstone Medical Packaging, Inc. |
| Jun 8, 2026 | Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French s... | Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufact... | Class II | Medline Industries, LP |
| Jun 8, 2026 | Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French s... | Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufact... | Class II | Medline Industries, LP |
| Jun 8, 2026 | MEDLINE medical procedure convenience kit labeled as: HIP CDS-LF, Medline ... | The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochl... | Class I | Medline Industries, LP |
| Jun 8, 2026 | Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French s... | Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufact... | Class II | Medline Industries, LP |
| Jun 8, 2026 | Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 12 mm 027... | Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implan... | Class II | Micro Therapeutics, Inc. |
| Jun 8, 2026 | Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French s... | Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufact... | Class II | Medline Industries, LP |
| Jun 8, 2026 | Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French s... | Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufact... | Class II | Medline Industries, LP |
| Jun 8, 2026 | Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French s... | Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufact... | Class II | Medline Industries, LP |
| Jun 8, 2026 | Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 20 mm 027... | Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implan... | Class II | Micro Therapeutics, Inc. |
| Jun 8, 2026 | Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French s... | Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufact... | Class II | Medline Industries, LP |
| Jun 8, 2026 | Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French s... | Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufact... | Class II | Medline Industries, LP |
| Jun 8, 2026 | Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French s... | Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufact... | Class II | Medline Industries, LP |
| Jun 8, 2026 | MEDLINE medical procedure convenience kit labeled as: 1) TOTAL KNEE-LF, Med... | The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochl... | Class I | Medline Industries, LP |
| Jun 8, 2026 | Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536. | The potential for intermittent well-to-well bias on the A1c_E assay on the Atellica CH and Atelli... | Class II | Siemens Healthcare Diagnostics, Inc. |
| 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 | MEDLINE convenience kits labeled as: 1) TOTAL JOINT KIT, Medline Kit SKU D... | Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenie... | Class I | Medline Industries, LP |
| Jun 5, 2026 | MEDLINE convenience kits labeled as: 1) C-SECTION, Medline SKU DYNJ910835;... | Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenie... | Class I | Medline Industries, LP |
| Jun 5, 2026 | MEDLINE ANTERIOR HIP, Medline Kit SKU DYNJ909640G | Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenie... | Class I | Medline Industries, LP |
| 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 | Bone Marrow Tray, REF: CB0033TL; CB0355TLA | Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall reca... | Class I | Argon Medical Devices, 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.