Browse Device Recalls
2,087 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,087 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 2,087 FDA device recalls in 2026.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 30, 2026 | Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count, Prod... | Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration... | Class II | Medline Industries, LP |
| Jun 30, 2026 | Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count Bag, ... | Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration... | Class II | Medline Industries, LP |
| Jun 30, 2026 | Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions... | Potential for breach in sterile barrier of device packaging. | Class II | Boston Scientific Corporation |
| Jun 30, 2026 | Merge OrthoPACS, medical imaging diagnostic workstation | Thumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a d... | Class II | Merge Healthcare, Inc. |
| Jun 30, 2026 | Merge PACS, medical imaging diagnostic workstation | Thumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a d... | Class II | Merge Healthcare, Inc. |
| Jun 30, 2026 | Radial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions an... | Potential for breach in sterile barrier of device packaging. | Class II | Boston Scientific Corporation |
| Jun 30, 2026 | Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN: ... | Potential for breach in sterile barrier of device packaging. | Class II | Boston Scientific Corporation |
| Jun 30, 2026 | SnapshotGLO Wound Imaging Device, Model KB100, KB100AA. | The software controlling the wound imaging device's battery charging circuit was not designed to ... | Class II | KENT IMAGING, INC. |
| Jun 30, 2026 | Rapid Refill Continuous Injection System, UPN M00566001 | Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There ... | Class II | Boston Scientific Corporation |
| Jun 29, 2026 | American Contract System Convenience Kits, CV B PACK, Model/Catalog Number: T... | The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubb... | Class II | American Contract Systems Inc |
| Jun 29, 2026 | American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TN... | The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubb... | Class II | American Contract Systems Inc |
| Jun 29, 2026 | American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TN... | The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubb... | Class II | American Contract Systems Inc |
| Jun 29, 2026 | American Contract System Convenience Kit, D & C PACK, Model/Catalog Number: L... | The Convenience Kits contain Medline's Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubb... | Class II | American Contract Systems Inc |
| Jun 29, 2026 | Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038... | Firmware issue potentially leading to loss of geometry movements. | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jun 29, 2026 | Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Int... | Carotid stent and post-dilation balloon system with integrated embolic protection system has an i... | Class II | Contego Medical, Inc |
| Jun 29, 2026 | GE Healthcare MAC VU360, REF# part number 2030361-023; Electrocardiograph | Software issue issue with the MAC VU360 v3.0 system. After selecting the order refresh icon, an ... | Class II | GE Medical Systems Information Technologies Inc |
| Jun 26, 2026 | Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product ... | Potential of failing to trigger clinical scan during Bolus Tracking. | Class II | Philips Healthcare (Suzhou) Co., Ltd. |
| Jun 26, 2026 | ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000 | A strong pull on the high-pressure transfer hose of cryosurgical unit may lead to pneumatic short... | Class II | Erbe USA Inc |
| Jun 26, 2026 | Boston Scientific Enhance Transcarotid/Peripheral Access Kit REF: SR-4F21G7D... | Black depth markings may detach from the outer sheath of the coaxial dilator introducer component... | Class II | Galt Medical Corporation |
| Jun 26, 2026 | Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Ca... | Out-of-specification sodium azide concentration in Syva Emit Disopyramide Enzyme Immunoassay Cali... | Class III | Siemens Healthcare Diagnostics, Inc. |
| Jun 26, 2026 | REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US), Electronic install... | Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results... | Class II | Beckman Coulter Inc. |
| Jun 26, 2026 | REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) on the foll... | Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results... | Class II | Beckman Coulter Inc. |
| Jun 26, 2026 | Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 1044539... | out-of-specification sodium azide concentration in Syva Emit Tox Serum Tricyclic Antidepressant C... | Class III | Siemens Healthcare Diagnostics, Inc. |
| Jun 25, 2026 | Pipeline Flex Embolization Device with Shield Technology REF PED2-300-12 UDI... | Due to incorrect label/product dimensions. Product is supposed to be 3.00 mm in diameter, but un... | Class II | Micro Therapeutics, Inc. |
| Jun 25, 2026 | Products that contain the Pericare Wipes: *Bardex¿ I.C. Complete Care¿ Foley... | Due to complaints received indicating presence of contamination on the surface of pericare wipes ... | Class II | C.R. Bard Inc |
| Jun 25, 2026 | Products that contain the Pericare Wipes: SureStep Intermittent Catheter Tra... | Due to complaints received indicating presence of contamination on the surface of pericare wipes ... | Class II | C.R. Bard Inc |
| Jun 25, 2026 | Products that contain the Pericare Wipes: (Canada Only) SureStep" Foley Tray ... | Due to complaints received indicating presence of contamination on the surface of pericare wipes ... | Class II | C.R. Bard Inc |
| Jun 25, 2026 | Products that contain the Pericare Wipes: Bardex Lubricath Foley Catheter ... | Due to complaints received indicating presence of contamination on the surface of pericare wipes ... | Class II | C.R. Bard Inc |
| Jun 25, 2026 | Products that contain the Pericare Wipes: Bard¿ Foley Tray With Lubri-Sil¿ A... | Due to complaints received indicating presence of contamination on the surface of pericare wipes ... | Class II | C.R. Bard Inc |
| Jun 25, 2026 | Products that contain the Pericare Wipes: SureStep" Foley Tray System Add-A-... | Due to complaints received indicating presence of contamination on the surface of pericare wipes ... | Class II | C.R. Bard Inc |
| Jun 25, 2026 | Brand Name: Quantum Rehab Product Name: Quantum 4Front 2HD Model/Catalog Nu... | If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appe... | Class II | Pride Mobility Products Corp. |
| Jun 25, 2026 | Brand Name: Quantum Rehab Product Name: Q6 Edge 2.0 (ilevel) Model/Catalog ... | If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appe... | Class II | Pride Mobility Products Corp. |
| Jun 25, 2026 | Brand Name: Quantum Rehab Product Name: Q6 Edge 4 Model/Catalog Number: Q6 ... | If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appe... | Class II | Pride Mobility Products Corp. |
| Jun 25, 2026 | Brand Name: Quantum rehab Product Name: Q6 Edge 2.0 Model/Catalog Number: Q... | If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appe... | Class II | Pride Mobility Products Corp. |
| Jun 25, 2026 | Brand Name: Quantum Rehab Product Name: Q6 Edge 3 Model/Catalog Number: Q6 ... | If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appe... | Class II | Pride Mobility Products Corp. |
| Jun 25, 2026 | Brand Name: Quantum Rehab Product Name: R-TRAK Model/Catalog Number: R-TRAK... | If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appe... | Class II | Pride Mobility Products Corp. |
| Jun 25, 2026 | Brand Name: Quantum Rehab Product Name: Quantum Rival Model/Catalog Number:... | If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appe... | Class II | Pride Mobility Products Corp. |
| Jun 25, 2026 | Brand Name: Quantum Rehab Product Name: Q6 Edge HD Model/Catalog Number: Q6... | If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appe... | Class II | Pride Mobility Products Corp. |
| Jun 25, 2026 | Brand Name: Quantum Rehab Product Name: Quantum 1450 Model/Catalog Number: ... | If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appe... | Class II | Pride Mobility Products Corp. |
| Jun 25, 2026 | Brand Name: Quantum Rehab Product Name: 4Front Model/Catalog Number: 4Front... | If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appe... | Class II | Pride Mobility Products Corp. |
| Jun 25, 2026 | Brand Name: Quantum Rehab Product Name: Quantum 4Front 2 Model/Catalog Numb... | If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appe... | Class II | Pride Mobility Products Corp. |
| Jun 25, 2026 | Brand Name: Quantum Rehab Product Name: Quantum Outback Model/Catalog Numbe... | If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appe... | Class II | Pride Mobility Products Corp. |
| Jun 25, 2026 | Brand Name: Quantum Rehab Product Name: Q6 Edge 3 Stretto Model/Catalog Num... | If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appe... | Class II | Pride Mobility Products Corp. |
| Jun 25, 2026 | Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that pro... | Due to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage t... | Class I | ResMed Ltd. |
| Jun 24, 2026 | BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 ... | Due to increase in false negative results | Class II | BioFire Diagnostics, LLC |
| Jun 24, 2026 | Dermalon 88861757-31 DERMALON* 4-0 BLU 75CM C13 88861757-31 88861799... | Product may contain a perforation or tear in the sterile barrier packaging. This issue may result... | Class II | Covidien, LP |
| Jun 24, 2026 | Surgipro SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X36 SP-623 | Product may contain a perforation or tear in the sterile barrier packaging. This issue may result... | Class II | Covidien, LP |
| Jun 24, 2026 | V-Loc 90 Absorbable Wound Closure Device VLOC 90 0 VL 22 GS-21 VLOCM033... | Product may contain a perforation or tear in the sterile barrier packaging. This issue may result... | Class II | Covidien, LP |
| Jun 24, 2026 | Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX | Product may contain a perforation or tear in the sterile barrier packaging. This issue may result... | Class II | Covidien, LP |
| Jun 24, 2026 | V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING ... | Product may contain a perforation or tear in the sterile barrier packaging. This issue may result... | Class II | Covidien, 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.