Browse Device Recalls

3,013 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,013 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 3,013 FDA device recalls in 2018.

Date	Product	Reason	Class	Firm
Dec 3, 2018	Pentax Medical C2 CryoBalloon Standard 90 degree Catheter, Model FG 1030, Ste...	Incorrect default dose and dose increments may be transmitted to the controller if the catheter R...	Class II	PENTAX of America Inc
Dec 3, 2018	Pentax Medical C2 CryoBalloon Pear Focal Catheter, Model FG 1024, Sterile, RX...	Incorrect default dose and dose increments may be transmitted to the controller if the catheter R...	Class II	PENTAX of America Inc
Dec 3, 2018	Fructosamine Calibrator, FR2993 This product is intended for in vitro use ...	The firm is conducting a Device Modification for Fructosamine Calibrator, Fructosamine Control 1 ...	Class II	Randox Laboratories Ltd.
Dec 3, 2018	Ingenia Elition S, Ingenia Elition X	During automatic tabletop movement, pressing and holding the Stop Table button may lead to an u...	Class II	Philips Medical Systems Nederlands
Dec 3, 2018	C2 CryoBalloon Controller, REF: FG-1017, with Controller Software v1.18.258 ...	The Controller does not detect overpressure in the balloon during the application of non-dosing p...	Class II	PENTAX of America Inc
Dec 3, 2018	Fructosamine Control 3, FR2996 This product is intended for in vitro use ...	The firm is conducting a Device Modification for Fructosamine Calibrator, Fructosamine Control 1 ...	Class II	Randox Laboratories Ltd.
Dec 3, 2018	Pentax Medical C2 CryoBalloon Standard Focal Catheter, Model FG 1028, Sterile...	Incorrect default dose and dose increments may be transmitted to the controller if the catheter R...	Class II	PENTAX of America Inc
Dec 3, 2018	iTotal CR Total Knee Replacement System, TCR-121-1111 (Catalog No.) / TCR-121...	The kits were prepared with incorrect patient ID labels and may contain incorrect components.	Class II	Conformis, Inc.
Dec 1, 2018	MED-RX POLYURETHANE FEEDING TUBE For Pediatric Use with Orange Radioplaque St...	The product may be packaged with a 5FR X 24 length Feeding tube instead of a 6.5 FR X 24 Feedin...	Class II	Canadian Hospital Specialties
Nov 30, 2018	System, Tomography Computed Emmission	GE Healthcare has identified that a small number of Nuclear Medicine systems are operating withou...	Class II	GE Healthcare, LLC
Nov 30, 2018	BVI Visitec Soft Tip Cannula, 0.8MM .50 x 33mm (25G x 1.3 in). The BVI Sof...	Certain lots are missing a protective sheath component over the silicone tip, which may result in...	Class II	Beaver Visitec
Nov 30, 2018	Siemens Biograph Horizon PET/CT System, Product Usage: The Siemens Biogr...	Improper design or specifications.	Class II	Siemens Medical Solutions USA, Inc.
Nov 30, 2018	AIA-PACK B12 (Vitamin B12) is designed for IN VITRO DIAGNOSTIC USE ONLY for t...	Potential for fluorescein interference to cause inaccurately elevated results for certain Tosoh A...	Class II	Tosoh Bioscience Inc
Nov 30, 2018	System, Tomography Computed Emmission	GE Healthcare has identified that a small number of Nuclear Medicine systems are operating withou...	Class II	GE Healthcare, LLC
Nov 30, 2018	ST AIA-PACK FT3 (FT3: Free Triiodothyronine) is designed for IN VITRO DIAGNOS...		Class II	Tosoh Bioscience Inc
Nov 30, 2018	ST AIA-PACK Testosterone (TES) is designed for IN VITRO DIAGNOSTIC USE ONLY f...		Class II	Tosoh Bioscience Inc
Nov 30, 2018	ST AIA-PACK Homocysteine (HCY) is designed for IN VITRO DIAGNOSTIC USE ONLY f...		Class II	Tosoh Bioscience Inc
Nov 30, 2018	Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2	Philips has discovered through customer complaints and internal testing an intermittent electroni...	Class II	Philips Medical Systems Nederlands
Nov 30, 2018	AIA-PACK Folate (FOL) is designed for IN VITRO DIAGNOSTIC USE ONLY for the qu...		Class II	Tosoh Bioscience Inc
Nov 30, 2018	ST AIA-PACK ACTH (ACTH: Adrenocorticotropic Hormone) is designed for IN VITRO...		Class II	Tosoh Bioscience Inc
Nov 29, 2018	Sensis Vibe System, Model Number 11007642, with software version VD10B.	A software error may result in a system crash. The system must be restarted before the clinical ...	Class II	Siemens Medical Solutions USA, Inc
Nov 29, 2018	Vitros Myoglobin Calibrators, Product Code 6801043 For use in the calibration...	A stability issue in the calibrators may cause calibration failures or atypical Quality Control r...	Class II	Ortho Clinical Diagnostics Inc
Nov 29, 2018	OMNI K1 Broach Handle, Product Code HS-10054	There is a potential for the inner pin of the handle to become loose and fall out.	Class II	OMNIlife science Inc.
Nov 28, 2018	Maximum Variable Pitch Compression Tray Base, Reference Number 231201002 P...	There is a potential for silicone shedding during cleaning and sterilization.	Class II	Zimmer Biomet, Inc.
Nov 28, 2018	IntellaTip MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irri...	Supplier had changed its resin sub-suppliers three (3) times without notifying BSC. These change...	Class III	Boston Scientific Corporation
Nov 28, 2018	Blazer Open-Irrigated Ablation Batch Catheter Product Usage: Open Irrig...	Supplier had changed its resin sub-suppliers three (3) times without notifying BSC. These change...	Class III	Boston Scientific Corporation
Nov 28, 2018	Maximum Variable Pitch Compression Screw Caddy, Reference Number 231201003 ...	There is a potential for silicone shedding during cleaning and sterilization.	Class II	Zimmer Biomet, Inc.
Nov 28, 2018	Tritanium Posterior Lumbar (PL) cage intervertebral body fusion implant. Int...	The surgical technique is being updated to caution against misuse due to reports of cage fracture...	Class II	Howmedica Osteonics Corp.
Nov 28, 2018	ImplantDirect InterActive Precision IO Scan Adapter, Part #6534-09PT, Platfor...	The peek part was loose on the titanium base of the device which could result in it falling into ...	Class II	Implant Direct Sybron Manufacturing, LLC
Nov 28, 2018	ImplantDirect InterActive Precision IO Scan Adapter, Part #6530-09PT, Platfor...	The peek part was loose on the titanium base of the device which could result in it falling into ...	Class II	Implant Direct Sybron Manufacturing, LLC
Nov 28, 2018	IntellaNav MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irri...	Supplier had changed its resin sub-suppliers three (3) times without notifying BSC. These change...	Class III	Boston Scientific Corporation
Nov 27, 2018	RESERVOIR "Y" ADAPTER, (a) BT920 (b) BT926 Suction and Anticoagulation ...	Medtronic discovered that certain Y-connectors included in the suction lines have exhibited teari...	Class II	Medtronic Perfusion Systems
Nov 27, 2018	Endoform Dermal Template 4x5, SKU 529313 Product Usage: Endoform Dermal T...	Potential for pouch seal failure	Class II	AROA BIOSURGERY
Nov 27, 2018	Endoform Dermal Template 2x2, SKU 529311 Product Usage: Endoform Dermal T...	Potential for pouch seal failure	Class II	AROA BIOSURGERY
Nov 27, 2018	ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Samp...	Reports of pressure tubing separation between the sampling port and the high pressure tubing on c...	Class II	ICU Medical, Inc.
Nov 27, 2018	Laparotomy Sponge, XR No Loop, Single-Use, Sterile, 18'' x 18'' pre-washed wi...	Potential compromise of product sterility due to breach of sterile barrier.	Class II	Medical Action Industries Inc
Nov 27, 2018	Endoform Dermal Template 2x2, SKU 529312 Product Usage: Endoform Dermal T...	Potential for pouch seal failure	Class II	AROA BIOSURGERY
Nov 27, 2018	ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Samp...	Reports of pressure tubing separation between the sampling port and the high pressure tubing on c...	Class II	ICU Medical, Inc.
Nov 27, 2018	SUCTION / ANTICOAGULATION ASSEMBLY (a) BTC93 (b) BTC98 Suction and Antic...	Medtronic discovered that certain Y-connectors included in the suction lines have exhibited teari...	Class II	Medtronic Perfusion Systems
Nov 27, 2018	ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Samp...	Reports of pressure tubing separation between the sampling port and the high pressure tubing on c...	Class II	ICU Medical, Inc.
Nov 26, 2018	ProtectIV¿ Plus Safety IV Catheter, sterile. Packaged in a pouch and than in...	Certain lots of the Model 306701 ProtectIV¿ Plus Safety IV Catheter may exhibit damage on the saf...	Class II	Smiths Medical ASD Inc.
Nov 26, 2018	Reliance LITe Nerve Hook Bayoneted, 90, Blunt Tip, REF # 48066103 The blu...	Instead of having a spherical diameter, the probe was observed to have 2 radii and a flat surface...	Class II	Howmedica Osteonics Corp.
Nov 23, 2018	HeartStart MRx, Rechargeable Li-Ion (lithium ion battery), REF: M3538A, which...	Affected lithium-ion batteries may contain a defective component (Thermal Cut-off or TCO). Should...	Class II	Philips North America LLC
Nov 21, 2018	Alinity i Ferritin Reagent Kit, List Number 07P6530 The Alinity i Ferriti...	Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in so...	Class II	Abbott Ireland Diagnostics Division
Nov 21, 2018	Alinity i 25-OH Vitamin D Reagent Kit, List Number 08P4532	Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in so...	Class II	Abbott Ireland Diagnostics Division
Nov 21, 2018	Alinity i TSH Reagent Kit, List Number 07P4830	Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in so...	Class II	Abbott Ireland Diagnostics Division
Nov 21, 2018	Alinity i Free T4 Reagent Kit, List Number 07P7030	Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in so...	Class II	Abbott Ireland Diagnostics Division
Nov 21, 2018	Alinity i Estradiol Reagent Kit, List Number 07P5020	Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in so...	Class II	Abbott Ireland Diagnostics Division
Nov 21, 2018	da Vinci X Surgical System	Due to a manufacturing variation in the arm that can result in a persistent recoverable fault err...	Class II	Intuitive Surgical, Inc.
Nov 21, 2018	Bag size #4 Custom Convenience Kits Usage: Surgical convenience kits ...	Potential that product has not reached complete sterilization,	Class II	American Contract Systems, 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.