Browse Device Recalls
3,664 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,664 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 3,664 FDA device recalls, Class I.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 11, 2026 | ABIOMED Impella CP Introducer Kit 14 Fr, 25 cm, Pump Set Code 0052-0039, cont... | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines... | Class I | Abiomed, Inc. |
| Jun 11, 2026 | ABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Produc... | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines... | Class I | Abiomed, Inc. |
| Jun 11, 2026 | ABIOMED Insertion Kit, Pkgd, JP, Pump Set Code 0052-0011-JP; containing Intro... | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines... | Class I | Abiomed, Inc. |
| Jun 11, 2026 | ABIOMED Impella CP Introducer Kit 14 Fr, 13 and 25 cm, Pump Set Code 1000550,... | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines... | Class I | Abiomed, Inc. |
| Jun 11, 2026 | ABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038, cont... | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines... | Class I | Abiomed, Inc. |
| Jun 11, 2026 | ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella In... | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines... | Class I | Abiomed, Inc. |
| Jun 10, 2026 | Abiomed REF: 0052-3006, 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 | Abiomed REF: 0052-3021, 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 | 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 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 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 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 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 |
| Jun 1, 2026 | T-Lok Bone Marrow Tray, REF: BMT1104STL; BMET1104TL; BMT1104CATL | Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall reca... | Class I | Argon Medical Devices, Inc |
| Jun 1, 2026 | One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular | Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall reca... | Class I | Argon Medical Devices, Inc |
| Jun 1, 2026 | Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF... | Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall reca... | Class I | Argon Medical Devices, Inc |
| Jun 1, 2026 | Arterial Line Kit 20ga x 6, REF: 400115A | Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall reca... | Class I | Argon Medical Devices, Inc |
| Jun 1, 2026 | General Biospy Tray, REF: GUTS1000 | Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall reca... | Class I | Argon Medical Devices, Inc |
| May 29, 2026 | Breathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with... | Ventilator coaxial breathing circuit may have, expiratory valve sets with membranes sticking to v... | Class I | Hamilton Medical AG |
| May 22, 2026 | Medtronic Harmony Delivery Catheter System | Devices containing inner shaft assemblies from specific manufacturing lots may have an increased ... | Class I | Medtronic Heart Valves Division |
| May 22, 2026 | Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected... | Potential for thrombus formation during prolonged use of the introducer. | Class I | Abiomed, Inc. |
| May 22, 2026 | Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set ... | Potential for thrombus formation during prolonged use of the introducer. | Class I | Abiomed, Inc. |
| May 22, 2026 | Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set ... | Potential for thrombus formation during prolonged use of the introducer. | Class I | Abiomed, Inc. |
| May 22, 2026 | Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected... | Potential for thrombus formation during prolonged use of the introducer. | Class I | Abiomed, Inc. |
| May 21, 2026 | Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Cata... | There have been reports of air and medication leakage from the nebulizer cup during therapy of Vo... | Class I | Baxter Healthcare Corporation |
| May 21, 2026 | Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catal... | There have been reports of air and medication leakage from the nebulizer cup during therapy of Vo... | Class I | Baxter Healthcare Corporation |
| May 21, 2026 | A M S, ALIGNED MEDICAL SOLUTIONS, Preop Kit-NS, Pack Number AMS18227, surgica... | Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the d... | Class I | Windstone Medical Packaging, Inc. |
| May 21, 2026 | A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgi... | Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the d... | Class I | Windstone Medical Packaging, Inc. |
| May 21, 2026 | Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit), Model/... | There have been reports of air and medication leakage from the nebulizer cup during therapy of Vo... | Class I | Baxter Healthcare Corporation |
| May 21, 2026 | A M S, ALIGNED MEDICAL SOLUTIONS, Thyroid FNA Pack-RX, Pack Number AMS17729, ... | Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the d... | Class I | Windstone Medical Packaging, Inc. |
| May 21, 2026 | A M S, ALIGNED MEDICAL SOLUTIONS, Dr. Lewin Pack, Pack Number AMS7200D, surgi... | Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the d... | Class I | Windstone Medical Packaging, Inc. |
| May 21, 2026 | Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Ca... | There have been reports of air and medication leakage from the nebulizer cup during therapy of Vo... | Class I | Baxter Healthcare Corporation |
| May 20, 2026 | Omnipod (Eros) Pod. Includes the below Model/REF Numbers: 1. POD-ZXP425 (... | External soft cannula damage during manufacturing that results in insulin leaking around the Pod ... | Class I | Insulet Corporation |
| May 20, 2026 | Omnipod DASH Pod. Includes the below Model/REF Numbers: 1. POD-BLE-I1-525... | External soft cannula damage during manufacturing that results in insulin leaking around the Pod ... | Class I | Insulet Corporation |
| May 20, 2026 | Omnipod 5 Pods. Includes the below Model/REF Numbers: 1. POD-OMNI-I1-6720... | External soft cannula damage during manufacturing that results in insulin leaking around the Pod ... | Class I | Insulet Corporation |
| May 18, 2026 | Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, ... | Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms ... | Class I | Abiomed, Inc. |
| May 15, 2026 | Reprocessed Electrophysiology Catheters and Ultrasound Catheters Item no. ... | Expansion of RES 98277. Specific lots of reprocessed catheters may contain small particles of res... | Class I | Medline Industries, LP |
| May 14, 2026 | Automated Impella Controller (AIC), for use with left heart support blood pum... | Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction wi... | Class I | Abiomed, Inc. |
| May 13, 2026 | Pack Angiography NCMC 3/Cs BANNER, REF: NCAG62I, containing Medline Namic Ang... | Cardiovascular procedure kits contain manifolds, the subject of another recall, that may have par... | Class I | Medical Action Industries, Inc. 306 |
| May 8, 2026 | Panda Freestanding Warmer, Infant Radiant Warmer Product Identifiers: 2063568... | Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system ca... | Class I | Datex-Ohmeda Inc |
| May 8, 2026 | Giraffe Warmer with Integrated Resuscitation System (iRes), Panda Warmer with... | Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system ca... | Class I | Datex-Ohmeda Inc |
| May 8, 2026 | Giraffe Stand-alone Infant Resuscitation System; Powered emergency ventilator... | Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system ca... | Class I | Datex-Ohmeda Inc |
| May 7, 2026 | Atlan A350. Model Number: 8211500. anesthesia workstation | The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use o... | Class I | Draeger, Inc. |
| May 7, 2026 | Atlan A350XL. Model Number: 8621600. anesthesia workstation | The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use o... | Class I | Draeger, Inc. |
| May 6, 2026 | Medline Convenience Kits: 1) OPEN HEART CDS, Model Number: CDS840144Q; 2)... | The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Inj... | Class I | Medline Industries, LP |
| May 6, 2026 | Medline Convenience Kits: 1) DRAWER 6 CENTRAL LINE INSERTIO, Model Number: ... | The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Inj... | Class I | Medline Industries, LP |
| May 6, 2026 | Medline Convenience Kits: 1) DRAWER 6A ADULT CENTRAL LINE, Model Number: AC... | The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Inj... | Class I | Medline Industries, LP |
| May 6, 2026 | Medline Convenience Kits: 1) DYNJ905503F, Model Number: CV ANESTHESIA - ROO... | The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Inj... | Class I | 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.