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 |
|---|---|---|---|---|
| Sep 3, 2026 | HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009800127. in vitro diagnostic | Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples. | Class I | Instrumentation Laboratory |
| Sep 3, 2026 | HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009802028. in vitro diagnostic (... | Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples. | Class I | Instrumentation Laboratory |
| Sep 3, 2026 | VentStar Resus Neo. Neonatal. 25 Units per Box. Part Number: MP00310 Dispo... | Potential cracks in the hose, which could lead to leakage or the hose falling off. | Class I | Draeger, Inc. |
| Aug 24, 2026 | Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5; ... | Tip may fracture or detach, leading to device fragments remaining within the patient or migrating... | Class I | Boston Scientific Corporation |
| Aug 19, 2026 | BD Alaris Pump Infusion Sets 10561554* 10885403232565 50885403232563 BD Alari... | Due to discrepancies in specific attributes in the performance data for infusion sets, which may ... | Class I | BD SWITZERLAND SARL |
| Aug 14, 2026 | Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories, Hand P... | Potential fire hazard involving the hand control pendant and associated wiring used with affected... | Class I | Medline Industries, LP |
| Aug 14, 2026 | Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories MDR1... | Potential fire hazard involving the hand control pendant and associated wiring used with affected... | Class I | Medline Industries, LP |
| Aug 12, 2026 | Impella Optical Controller, Automated Impella Controller, Impella Connect Pac... | The potential for purge cassette recognition issues due to the failure of the purge flag componen... | Class I | Abiomed, Inc. |
| Aug 12, 2026 | Impella Optical Controller with the below product descriptions and correspond... | The potential for purge cassette recognition issues due to the failure of the purge flag componen... | Class I | Abiomed, Inc. |
| Aug 12, 2026 | Automated Impella Controller (AIC) with the below product descriptions and co... | The potential for purge cassette recognition issues due to the failure of the purge flag componen... | Class I | Abiomed, Inc. |
| Aug 11, 2026 | INCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set. Stay-Flex ... | Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during... | Class I | CooperSurgical, Inc. |
| Aug 11, 2026 | INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set. Stay-... | Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during... | Class I | CooperSurgical, Inc. |
| Aug 11, 2026 | Medline Convenience Kits: 1) PORT ACCESS KIT UNIV OF ALA, Catalog Number: DY... | The kits contain certain lots of sterile applicators which may contain fungal contamination that ... | Class I | Medline Industries, LP |
| Aug 11, 2026 | Medline Convenience Kits: 1) ACC010308A, Catalog Number: ACC010308A; 2) AC... | The kits contain certain lots of sterile applicators which may contain fungal contamination that ... | Class I | Medline Industries, LP |
| Aug 11, 2026 | Medline Convenience Kits: 1) DYNDB3086D, Catalog Number: DYNDB3086D; 2) DYND... | The kits contain certain lots of sterile applicators which may contain fungal contamination that ... | Class I | Medline Industries, LP |
| Aug 11, 2026 | Medline Convenience Kits: 1) OPEN HEART ADULT, Catalog Number: CDS840396Y; ... | The kits contain certain lots of sterile applicators which may contain fungal contamination that ... | Class I | Medline Industries, LP |
| Aug 11, 2026 | Medline Convenience Kits: 1) DYNDH1193, Catalog Number: DYNDH1193; 2) DYND... | The kits contain certain lots of sterile applicators which may contain fungal contamination that ... | Class I | Medline Industries, LP |
| Aug 11, 2026 | Medline Convenience Kits: 1) KIT ANESTHESIA L&D A- LINE SET, Catalog Number:... | The kits contain certain lots of sterile applicators which may contain fungal contamination that ... | Class I | Medline Industries, LP |
| Aug 11, 2026 | Medline Convenience Kits: 1) DYKM1000B, Catalog Number: DYKM1000B; 2) DYKM... | The kits contain certain lots of sterile applicators which may contain fungal contamination that ... | Class I | Medline Industries, LP |
| Aug 10, 2026 | DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625150; DuoGlide Short... | this is a downstream recall of class I recall RES 98777 | Class I | Bard Access Systems, Inc. |
| Aug 10, 2026 | Haylard CONTINUOUS NERVE BLOCK TRAY; Model/Item Number (Kit): BMCN001-05; | Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampu... | Class I | AVID Medical, Inc. |
| Aug 10, 2026 | Power-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605150; Power-... | this is a downstream recall of class I recall RES 98777 | Class I | Bard Access Systems, Inc. |
| Aug 10, 2026 | Haylard BASIC BIOPSY TRAY; Model/Item Number (Kit): PM415; | Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampu... | Class I | AVID Medical, Inc. |
| Aug 10, 2026 | Haylard UNIV IMAGING BIOPSY TRUCUSTOM; Model/Item Number (Kit): VARV042-03; | Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampu... | Class I | AVID Medical, Inc. |
| Aug 10, 2026 | Haylard 18G SINGLE SHOT EPI TRAY; Model/Item Number (Kit): DPGE002-02; | Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampu... | Class I | AVID Medical, Inc. |
| Aug 6, 2026 | Bravo CF capsule delivery device, 5-pack, Product Number FGS-0635, Bravo ... | Capsule may fail to attach to the esophagus or detach from the delivery device. Risks include pat... | Class I | Given Imaging Ltd. |
| Jul 30, 2026 | BD Needle Kit for Powered Driver 15mm x 15Ga, REF: D015151NK, BD Needle Kit ... | After placement of intraosseous (IO) needle sets, used when intravenous access is difficult or im... | Class I | Bard Access Systems, Inc. |
| Jul 29, 2026 | StatStrip Glucose Hospital Meter System. Model No: 66739. Glucose test system. | A software synchronization/timing issue in the barcode scanning and patient data processing compo... | Class I | Nova Biomedical Corporation |
| Jul 29, 2026 | StatStrip Glucose and B- Ketone meter. Model No: 66429. Glucose test system. | A software synchronization/timing issue in the barcode scanning and patient data processing compo... | Class I | Nova Biomedical Corporation |
| Jul 29, 2026 | StatStrip Glucose Hospital Meter System. Model No: 63685. Glucose test system. | A software synchronization/timing issue in the barcode scanning and patient data processing compo... | Class I | Nova Biomedical Corporation |
| Jul 29, 2026 | StatStrip Glucose and B- Ketone meter. Model No: 63683. Glucose test system. | A software synchronization/timing issue in the barcode scanning and patient data processing compo... | Class I | Nova Biomedical Corporation |
| Jul 29, 2026 | StatStrip Glucose and B- Ketone meter. Model No: 63910. Glucose test system. | A software synchronization/timing issue in the barcode scanning and patient data processing compo... | Class I | Nova Biomedical Corporation |
| Jul 23, 2026 | Kit: Epidural/Pain TQC 20/Cs, REF: 82465 Containing Sodium Chloride Injection... | Kits containing Sodium Chloride ampules subject to another recall are recalled due to potentially... | Class I | Medical Action Industries, Inc. 306 |
| Jul 23, 2026 | Kit: Single Shot Epidural 20/Cs, REF: 59553; Kit: Single Shot Epidural 20/Cs... | Kits containing Sodium Chloride ampules subject to another recall are recalled due to potentially... | Class I | Medical Action Industries, Inc. 306 |
| Jul 22, 2026 | Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep ... | Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may be contaminated with... | Class I | AVID Medical, Inc. |
| Jul 15, 2026 | BMC/REACTHEALTH Luna G3 APAP REF LG 3600 | Retroactive reporting for 2024 rework conducted at the 3B/React Health warehouse | Class I | BMC Medical Co., Ltd. |
| Jul 14, 2026 | Halyard IV START KIT NON-STERILE REF: KRIV26-02 | Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which are ... | Class I | AVID Medical, Inc. |
| Jul 9, 2026 | Boston Scientific ENROUTE Transcarotid Neuroprotection System, Material Numb... | Potential for arterial sheath tip separation or partial tip separation during use. | Class I | Boston Scientific Corporation |
| Jul 9, 2026 | Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material... | Potential for arterial sheath tip separation or partial tip separation during use. | Class I | Boston Scientific Corporation |
| Jul 6, 2026 | Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride I... | Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance... | Class I | Spectra Medical Devices, Llc |
| Jun 30, 2026 | Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507;... | Baxter received customer reports of air bubbles in the drip chamber and tubing when a pressure cu... | Class I | Baxter Healthcare Corporation |
| 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 17, 2026 | INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500; INF... | Spinal cord stimulation system lead body may be exposed to stress at the anchor site. This may re... | Class I | Boston Scientific Neuromodulation Corporation |
| Jun 11, 2026 | ABIOMED Introducer Kit 23 Fr, 11 cm, Pump Set Code 1000441, containing Kit, 2... | 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 Smart Assist Set, JP, Pump Set Code 0048-0024-JP; containi... | 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 Intro Kit, 14Fr x 13 and 25 cm, PKGD, JP, Pump Set Code 0052-0023-JP;... | 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 5.5 Smart Assist Set, JP, Pump Set Codes 1000211, 1000212; co... | 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 0048-0044; 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 Impella RP Flex with SmartAssist Set, Pump Set Code 1000323, containi... | 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 5.5 SmartAssist S2 Set, JP, Pump Set Codes 1000459, 1000460; ... | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines... | Class I | Abiomed, 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.