Browse Device Recalls

3,133 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,133 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 3,133 FDA device recalls.

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Date	Product	Reason	Class	Firm
Sep 10, 2025	TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curve D), RE...	Abbott has become aware of a limited number of tip detachment events during catheter removal from...	Class I	Abbott
Sep 10, 2025	TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), ...	Abbott has become aware of a limited number of tip detachment events during catheter removal from...	Class I	Abbott
Sep 10, 2025	TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), ...	Abbott has become aware of a limited number of tip detachment events during catheter removal from...	Class I	Abbott
Sep 9, 2025	BioPro Femoral Head (Ceramic heads 28-30) Product ID/Description 19023 HE...	Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of...	Class II	BioPro, Inc.
Sep 9, 2025	BioPro Endo Head (Metal uni-polar, 38-55) Product Number/Description 10...	Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of...	Class II	BioPro, Inc.
Sep 9, 2025	BioPro Femoral Head Product ID/Description 14089 HEAD FEMORAL 28 SH LT ...	Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of...	Class II	BioPro, Inc.
Sep 9, 2025	BioPro Endo Head (Ceramic) Product ID/Description 13006 ENDO MODULAR CERA...	Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of...	Class II	BioPro, Inc.
Sep 9, 2025	BioPro Femoral Head (Metal 22, 28, 32, 36, 40) cobalt chromium and ceramic he...	Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of...	Class II	BioPro, Inc.
Sep 9, 2025	BioPro Bipolar Head Product ID/Description 18130 BIPOLAR HEAD 38MM 18131...	Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of...	Class II	BioPro, Inc.
Sep 6, 2025	Cyclopen Microinterventional Cyclodialysis System. Model Number: CP-300. P...	Potential for compromised integrity of the sterile packaging.	Class II	Iantrek Inc.
Sep 6, 2025	C-Rex UNO Microinterventional Goniotomy Instrument. Model Number: CRX-120. ...	Potential for compromised integrity of the sterile packaging.	Class II	Iantrek Inc.
Sep 2, 2025	Tribio Implant 7.5mm x 40mm REF M80 SB008 UDI code: (01) 00816125023653(10) ...	Due to incorrect product label (Incorrect product name identified on outer packaging).	Class II	Berkeley Advanced Biomaterials, LLC
Aug 29, 2025	NES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy Catheter. Model Numbe...	Potential for breaches in the sterile barrier packaging, compromising sterility assurance.	Class II	Northeast Scientific Inc.
Aug 29, 2025	NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter. Model/Catalo...	Potential for breaches in the sterile barrier packaging, compromising sterility assurance.	Class II	Northeast Scientific Inc.
Aug 29, 2025	NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter. Model Number...	Potential for breaches in the sterile barrier packaging, compromising sterility assurance.	Class II	Northeast Scientific Inc.
Aug 29, 2025	NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter. Model Numbe...	Potential for breaches in the sterile barrier packaging, compromising sterility assurance.	Class II	Northeast Scientific Inc.
Aug 29, 2025	NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter. Model Numbe...	Potential for breaches in the sterile barrier packaging, compromising sterility assurance.	Class II	Northeast Scientific Inc.
Aug 29, 2025	NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter. Model Number...	Potential for breaches in the sterile barrier packaging, compromising sterility assurance.	Class II	Northeast Scientific Inc.
Aug 29, 2025	NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter. Model Numbe...	Potential for breaches in the sterile barrier packaging, compromising sterility assurance.	Class II	Northeast Scientific Inc.
Aug 29, 2025	NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter. Model Number...	Potential for breaches in the sterile barrier packaging, compromising sterility assurance.	Class II	Northeast Scientific Inc.
Aug 7, 2025	FloPatch FP120, REF: FP120-FOT01-005	Flowmeter patch as a human readable expiry date on the outer shipping packaging that reads 2025-0...	Class III	Flosonics Medical (R/A 1929803 ONTARIO CORP.)
Aug 5, 2025	Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Adhesive Sheet Mod...	Packaging failures were identified which could lead to a breach in the sterile barrier.	Class II	Integra LifeSciences Corp. (NeuroSciences)
Aug 5, 2025	Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Surgical Adhesive Sheet ...	Packaging failures were identified which could lead to a breach in the sterile barrier.	Class II	Integra LifeSciences Corp. (NeuroSciences)
Aug 5, 2025	Brand Name: MediHoney ¿ Product Name: MediHoney ¿ Tube Model/Catalog Number...	Packaging failures were identified which could lead to a breach in the sterile barrier.	Class II	Integra LifeSciences Corp. (NeuroSciences)
Aug 5, 2025	Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Model/Catalog Numb...	Packaging failures were identified which could lead to a breach in the sterile barrier.	Class II	Integra LifeSciences Corp. (NeuroSciences)
Aug 5, 2025	Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Sheet Dressing with Lept...	Packaging failures were identified which could lead to a breach in the sterile barrier.	Class II	Integra LifeSciences Corp. (NeuroSciences)
Aug 5, 2025	Brand Name: MediHoney¿ Product Name: MediHoney¿ Adhesive Hydrogel Sheet Dres...	Packaging failures were identified which could lead to a breach in the sterile barrier.	Class II	Integra LifeSciences Corp. (NeuroSciences)
Aug 5, 2025	Brand Name: CVS Honey Pad Product Name: CVS Honey Pad Model/Catalog Number:...	Packaging failures were identified which could lead to a breach in the sterile barrier.	Class II	Integra LifeSciences Corp. (NeuroSciences)
Aug 5, 2025	Brand Name: MediHoney ¿ Product Name: MediHoney¿ Paste Model/Catalog Number...	Packaging failures were identified which could lead to a breach in the sterile barrier.	Class II	Integra LifeSciences Corp. (NeuroSciences)
Jul 30, 2025	IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT1...	Dental implants were imported under temperature and storage conditions that do not comply with th...	Class II	S.I.N. Implant System Ltda
Jul 18, 2025	Brand Name: DJO SURGICAL Product Name: FA S Altivate Reverse Glenoid Tray M...	Their is a potential that the reamer may kick or bind up during or immediately prior to use.	Class II	Encore Medical, LP
Jul 1, 2025	Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy ...	Due to two issues: 1. Product contamination (biological foreign matter) that could compromise st...	Class II	Carefree Surgical Specialties
Jul 1, 2025	Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy ...	Due to two issues: 1. Product contamination (biological foreign matter) that could compromise st...	Class II	Carefree Surgical Specialties
Jul 1, 2025	Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy ...	Due to two issues: 1. Product contamination (biological foreign matter) that could compromise st...	Class II	Carefree Surgical Specialties
Jul 1, 2025	Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy ...	Due to two issues: 1. Product contamination (biological foreign matter) that could compromise st...	Class II	Carefree Surgical Specialties
Jun 12, 2025	Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobi...	Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued di...	Class II	Encore Medical, LP
Jun 12, 2025	Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobi...	Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued di...	Class II	Encore Medical, LP
Jun 12, 2025	Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, la...	Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by ...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Jun 12, 2025	Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, la...	Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by ...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Jun 12, 2025	Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, la...	Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by ...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Jun 12, 2025	Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, la...	Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by ...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Jun 3, 2025	BD Heyman Follower Coude Tip for following sizes: 12Fr - REF:021312 14Fr...	Cather packaging may contain the incorrect French size.	Class II	C.R. Bard Inc
Jun 3, 2025	BD Heyman Follower Straight Tip for following sizes: 10Fr - REF:21110, 1...	Cather packaging may contain the incorrect French size.	Class II	C.R. Bard Inc
Jun 3, 2025	REF: 123400,Bard Urologist's Tray, For the Obstructed Urethra	Cather packaging may contain the incorrect French size.	Class II	C.R. Bard Inc
Jun 2, 2025	Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KN...	Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use ...	Class II	Encore Medical, LP
Jun 2, 2025	Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KN...	Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use ...	Class II	Encore Medical, LP
May 23, 2025	Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-5...	Investigation has identified that the age of the nylon packaging material has caused a loss of in...	Class II	CORIN MEDICAL, LTD.
May 19, 2025	Brand Name: Hummingbird Product Name: Stimulated EMG Kit with Hummingbird - ...	Product packaging contains the wrong part number and kit contents.	Class II	Neurovision Medical Products Inc
May 15, 2025	Medline UMBILICAL TRAY W/3.5&5FR CATH, REF UVT1250	There is a possible packaging defect impacting the outer Tyvec pouch that protects the sterile pr...	Class II	MEDLINE INDUSTRIES, LP - Northfield
May 2, 2025	Catalog No. 8888160556; Umbilical Vessel Catheter 5 French dual lumen	Packaging defect may compromise sterility of the product. Use of a non-sterile product on the pat...	Class II	Cardinal Health 200, LLC

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.