Browse Device Recalls
39,162 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 39,162 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 39,162 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 29, 2026 | Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK RIVERSIDE HEALTH SYSTEM... | B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL... | Class II | B Braun Medical Inc |
| Jan 29, 2026 | Brand Name: B. BRAUN MEDICAL INC. Product Name: LYNDON B JOHNSON HOSPITAL SP... | B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL... | Class II | B Braun Medical Inc |
| Jan 29, 2026 | Brand Name: B. BRAUN MEDICAL INC. Product Name: BPSK, BLOCKJOCKS TRAY Model... | B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL... | Class II | B Braun Medical Inc |
| Jan 29, 2026 | Brand Name: B. BRAUN MEDICAL INC. Product Name: NES1725KFXL SPINAL EPID CLOS... | B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL... | Class II | B Braun Medical Inc |
| Jan 29, 2026 | Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK SHANDS JACKSONVILLE 200... | B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL... | Class II | B Braun Medical Inc |
| Jan 29, 2026 | Brand Name: B. BRAUN MEDICAL INC Product Name: CESK NORTHSIDE ANESTHESIA TRA... | B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL... | Class II | B Braun Medical Inc |
| Jan 29, 2026 | Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK HARRIS METHODIST Model... | B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL... | Class II | B Braun Medical Inc |
| Jan 29, 2026 | Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Para... | Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use. | Class II | ReCor Medical Inc. |
| Jan 29, 2026 | Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Para... | Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use. | Class II | ReCor Medical Inc. |
| Jan 29, 2026 | Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per... | Potential for rubber fragment detachment during use. | Class II | Olympus Corporation of the Americas |
| Jan 29, 2026 | Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per ... | Potential for rubber fragment detachment during use. | Class II | Olympus Corporation of the Americas |
| Jan 28, 2026 | Jiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011. | Composite polisher cups may crumble and break apart easily, which could cause a delay in patient ... | Class II | Ultradent Products, Inc. |
| Jan 28, 2026 | Medline Surgical Drapes: MDTBTCS6070GN DBD-DRAPE,COVER,TABLE,RESIS/XALT GRN,... | Fabric may experience premature delamination when using included laundering instructions. Identif... | Class II | Medline Industries, LP |
| Jan 28, 2026 | Medline Medcrest Surgical Gowns: MDTGXC4J5XL DBQ-GOWN,SURG,XALT,L4, CRTCL ... | Fabric may experience premature delamination when using included laundering instructions. Identif... | Class II | Medline Industries, LP |
| Jan 27, 2026 | CLARITY II Laser System; Model No. 1110200210. | Reports of devices sparking/popping and potentially burning patients. | Class II | Lutronic Corporation |
| Jan 27, 2026 | 10mL Non-Sterile BD Luer-Lok Tip Syringe Only. Catalog Number: 301029. 850 bu... | During the bulk packaging process, some Luer Slip syringes were incorrectly included in a batch d... | Class II | Becton Dickinson & Company |
| Jan 27, 2026 | Impella RP. Product Code: 0046-0011. | Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to... | Class I | Abiomed, Inc. |
| Jan 27, 2026 | Impella RP with SmartAssist. Product Code: 0046-0035. | Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to... | Class I | Abiomed, Inc. |
| Jan 27, 2026 | Impella RP Flex with SmartAssist. Product Code: 1000323. | Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to... | Class I | Abiomed, Inc. |
| Jan 26, 2026 | Azurion 5 M20 System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only... | Under certain conditions, the table may move unexpectedly when the Reset Geometry button is press... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 26, 2026 | Azurion 7 B20 System Model Numbers: (1)722068, (2)722226, (3)722236; Softwa... | Under certain conditions, the table may move unexpectedly when the Reset Geometry button is press... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 26, 2026 | Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Sof... | Under certain conditions, the table may move unexpectedly when the Reset Geometry button is press... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 26, 2026 | Azurion 3 M15 System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)7... | Under certain conditions, the table may move unexpectedly when the Reset Geometry button is press... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 26, 2026 | Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version ... | Under certain conditions, the table may move unexpectedly when the Reset Geometry button is press... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 26, 2026 | Azurion 7 B12 System Model Numbers:(1) 722067, (2) 722225, (3) 722235; Soft... | Under certain conditions, the table may move unexpectedly when the Reset Geometry button is press... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 26, 2026 | Azurion 7 M20 System Model Numbers: (1)722079, (2)722224, (3)722234, (4)7222... | Under certain conditions, the table may move unexpectedly when the Reset Geometry button is press... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 26, 2026 | Azurion 7 M12 System Model Numbers: (1)722078, (2)722223, (3)722233; Softwa... | Under certain conditions, the table may move unexpectedly when the Reset Geometry button is press... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 23, 2026 | Pelvic Reconstruction System (PRS) with the below descriptions and correspond... | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI... | Class II | I.T.S. GmbH |
| Jan 23, 2026 | Volar Radius Plate with Angular Stability with the following description: Rad... | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI... | Class II | I.T.S. GmbH |
| Jan 23, 2026 | Pilonplate with Angular Stability, with the below descriptions and correspond... | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI... | Class II | I.T.S. GmbH |
| Jan 23, 2026 | FR.O.H. Calcaneus Repair System with the following description: Anterolateral... | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI... | Class II | I.T.S. GmbH |
| Jan 23, 2026 | I.T.S. DUL (Distal Ulna Locking) System and UOL (Ulna Osteotomy Locking) Syst... | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI... | Class II | I.T.S. GmbH |
| Jan 23, 2026 | Brand Name: Humeral Head Plate with Angular Stability, with the following des... | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI... | Class II | I.T.S. GmbH |
| Jan 23, 2026 | Claviculaplate with Angular Stability, with the below descriptions and associ... | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI... | Class II | I.T.S. GmbH |
| Jan 23, 2026 | I.T.S. Fibula Plate PROlock with Angular Stability with the below description... | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI... | Class II | I.T.S. GmbH |
| Jan 23, 2026 | I.T.S. LRS (Locking Reconstruction System) with the below descriptions and co... | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI... | Class II | I.T.S. GmbH |
| Jan 23, 2026 | Brand Name: I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) with t... | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI... | Class II | I.T.S. GmbH |
| Jan 23, 2026 | I.T.S. Straight Plate with Angular Stability with the below descriptions and ... | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI... | Class II | I.T.S. GmbH |
| Jan 23, 2026 | Distal Humeral Plates with Angular Stability with the below descriptions and ... | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI... | Class II | I.T.S. GmbH |
| Jan 23, 2026 | HLS - Hand Locking Plates System with the below descriptions and correspondin... | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI... | Class II | I.T.S. GmbH |
| Jan 23, 2026 | I.T.S. Screw System with the below descriptions and corresponding article num... | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI... | Class II | I.T.S. GmbH |
| Jan 23, 2026 | Olecranonplate with Angular Stability with the below descriptions and corresp... | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI... | Class II | I.T.S. GmbH |
| Jan 23, 2026 | FLS - Foot Locking Plates System and HOL - Hallux Osteotomy Locking Plate wit... | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI... | Class II | I.T.S. GmbH |
| Jan 23, 2026 | HCS - Headless Compression Screw System, Headless Compression Screw, Cannulat... | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI... | Class II | I.T.S. GmbH |
| Jan 23, 2026 | CS100 IABP. Software Version CS100 IABP Q.01. | The firm has identified that the battery runtime and cycle specifications contained in the device... | Class II | Datascope Corp. |
| Jan 23, 2026 | CS300 IABP. Software Version CS300 IABP C.01. | The firm has identified that the battery runtime and cycle specifications contained in the device... | Class II | Datascope Corp. |
| Jan 21, 2026 | Adapt Pump, Model/Catalog Number: 61600200-Adapt Pump, component of Adapt sup... | Agiliti identified an issue where the Adapt Pump (61600200-Adapt Pump) supplied with all Adapt Li... | Class II | Agiliti Health - Ellis |
| Jan 21, 2026 | MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm... | Due to a need to update the product labeling (Instructions for Use IFU) as a result of the magnet... | Class II | Stryker Corporation |
| Jan 21, 2026 | PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog ... | Due to pediatric defibrillator electrode delamination | Class II | Physio-Control, Inc. |
| Jan 21, 2026 | EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5 | Toric Implantable Collamer for correction/reduction of myopia in phakic eyes with astigmatism wer... | Class II | Staar Surgical AG |
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.