Browse Device Recalls

1,503 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,503 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 1,503 FDA device recalls in FL.

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Date	Product	Reason	Class	Firm
Sep 14, 2016	BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 4MM(H) An endoss...	A limited number of product pouches may not have been sealed during packaging.	Class II	Biomet 3i, LLC
Sep 14, 2016	BIOMET 3i LOW PROFILE ABUTMENT (HEXED) PICK-UP IMPRESSION COPING An endosseo...	A limited number of product pouches may not have been sealed during packaging.	Class II	Biomet 3i, LLC
Sep 14, 2016	BIOMET 3i CERTAIN LOW PROFILE 30¿ ABUTMENT 4.1MM(D) X 5MM(H) An endosseous d...	A limited number of product pouches may not have been sealed during packaging.	Class II	Biomet 3i, LLC
Sep 14, 2016	BIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 3.4MM(D) X 4MM(H) An endosseous d...	A limited number of product pouches may not have been sealed during packaging.	Class II	Biomet 3i, LLC
Sep 14, 2016	BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 4MM(H) An endosseous den...	A limited number of product pouches may not have been sealed during packaging.	Class II	Biomet 3i, LLC
Sep 14, 2016	BIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 3.4MM(D) X 2MM(H) An endosseous d...	A limited number of product pouches may not have been sealed during packaging.	Class II	Biomet 3i, LLC
Sep 14, 2016	BIOMET 3i LOW PROFILE ABUTMENT NON-HEXED PREFORMANCE TEMPORARY CYLINDER An...	A limited number of product pouches may not have been sealed during packaging.	Class II	Biomet 3i, LLC
Sep 14, 2016	BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 4MM(H) An endoss...	A limited number of product pouches may not have been sealed during packaging.	Class II	Biomet 3i, LLC
Sep 14, 2016	BIOMET 3i CERTAIN LOW PROFILE 30¿ ABUTMENT 3.4MM(D) X 5MM(H) An endosseous d...	A limited number of product pouches may not have been sealed during packaging.	Class II	Biomet 3i, LLC
Sep 14, 2016	BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 2MM(H) An endosseous den...	A limited number of product pouches may not have been sealed during packaging.	Class II	Biomet 3i, LLC
Sep 14, 2016	BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 1MM(H) An endosseous den...	A limited number of product pouches may not have been sealed during packaging.	Class II	Biomet 3i, LLC
Sep 14, 2016	BIOMET 3i CERTAIN LOW PROFILE ABUTMENT 4.1MM(D) X 2MM(H) An endosseous denta...	A limited number of product pouches may not have been sealed during packaging.	Class II	Biomet 3i, LLC
Sep 14, 2016	BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 3MM(H) An endoss...	A limited number of product pouches may not have been sealed during packaging.	Class II	Biomet 3i, LLC
Sep 14, 2016	BIOMET 3i LOW PROFILE ABUTMENT (NON-HEXED) PICK-UP IMPRESSION COPING An en...	A limited number of product pouches may not have been sealed during packaging.	Class II	Biomet 3i, LLC
Sep 14, 2016	BIOMET 3i LOW PROFILE 17¿ ABUTMENT 4.1MM(D) X 2MM(H) An endosseous dental im...	A limited number of product pouches may not have been sealed during packaging.	Class II	Biomet 3i, LLC
Sep 14, 2016	BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 2MM(H) An endoss...	A limited number of product pouches may not have been sealed during packaging.	Class II	Biomet 3i, LLC
Sep 14, 2016	BIOMET 3i LOW PROFILE 30¿ ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental i...	A limited number of product pouches may not have been sealed during packaging.	Class II	Biomet 3i, LLC
Sep 14, 2016	BIOMET 3i CERTAIN LOW PROFILE ABUTMENT 4.1MM(D) X 1MM(H) An endosseous denta...	A limited number of product pouches may not have been sealed during packaging.	Class II	Biomet 3i, LLC
Sep 14, 2016	BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 2MM(H) An endoss...	A limited number of product pouches may not have been sealed during packaging.	Class II	Biomet 3i, LLC
Sep 14, 2016	BIOMET 3i LOW PROFILE ABUTMENT TITANIUM RETAINING SCREW An endosseous dental...	A limited number of product pouches may not have been sealed during packaging.	Class II	Biomet 3i, LLC
Sep 14, 2016	BIOMET 3i LOW PROFILE ABUTMENT 4.1MM(D) X 1MM(H) An endosseous dental implan...	A limited number of product pouches may not have been sealed during packaging.	Class II	Biomet 3i, LLC
Sep 14, 2016	BIOMET 3i LOW PROFILE ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental implan...	A limited number of product pouches may not have been sealed during packaging.	Class II	Biomet 3i, LLC
Sep 14, 2016	BIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 4.1MM(D) X 2MM(H) An endosseous d...	A limited number of product pouches may not have been sealed during packaging.	Class II	Biomet 3i, LLC
Sep 14, 2016	BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 3MM(H) An endosseous den...	A limited number of product pouches may not have been sealed during packaging.	Class II	Biomet 3i, LLC
Sep 14, 2016	BIOMET 3i LOW PROFILE 17¿ ABUTMENT 4.1MM(D) X 4MM(H) An endosseous dental im...	A limited number of product pouches may not have been sealed during packaging.	Class II	Biomet 3i, LLC
Aug 26, 2016	G1 Dissection Tool - 7mm FBALL L; For cutting and shaping bone including spin...	Product Code L- 7B-G1 was inadvertently released off of hold status and the affected products wer...	Class II	The Anspach Effort, Inc.
Aug 26, 2016	G1 Dissection Tool - 6MM CRS DBALL, 2mm Shaft EXP, M; For cutting and shaping...	The firm discovered on March 4, 2016 that several product codes were inadvertently left off of Ho...	Class II	The Anspach Effort, Inc.
Aug 26, 2016	G1 Dissection Tool - 3mm FLUTED BALL; For cutting and shaping bone including ...	The firm discovered on March 4, 2016 that several product codes were inadvertently left off of Ho...	Class II	The Anspach Effort, Inc.
Aug 26, 2016	G1 Dissection Tool - 3mm CRS DBALL, 2mm SHAFT EXP, M; For cutting and shaping...	The firm discovered on March 4, 2016 that several product codes were inadvertently left off of Ho...	Class II	The Anspach Effort, Inc.
Aug 17, 2016	HeartWare Ventricular Assist System (HVAD), US product: Model No.: 1103; and...	Foreign material found within the driveline connector of the HVAD Pump that could cause increased...	Class I	HeartWare, Inc
Aug 12, 2016	Arthrex Suture Washer	The device was assembled incorrectly. Suture and washer were not assembled; components were place...	Class III	Arthrex, Inc.
Aug 8, 2016	3I OSSEOTITE CERTAIN DENTAL IMPLANTS, 4x11.5 mm, Sterile, Rx only.	Product was incorrectly packaged.	Class II	Biomet 3i, LLC
Jul 21, 2016	INOVO Purefill Oxygen Compressor Model PF1100 Is an oxygen refill machine ...	Device can fail during operation.	Class II	Inovo, Inc
Jul 21, 2016	RENASYS Sterile Transparent Film and all the RENASYS Dressing kits that conta...	Sterility seal integrity failures on the Renasys Sterile Transparent Film	Class II	Smith & Nephew, Inc.
Jul 18, 2016	BVX-330NR Bovie Precise 360 Handpiece 33cm, needle Product is used for t...	The adhesive may be inadequately applied or the assembly may be manipulated after application of ...	Class II	Bovie Medical Corporation
Jul 18, 2016	BVX-450BR Bovie Precise 360 Handpiece 45cm, blade Product is used for the ...	The adhesive may be inadequately applied or the assembly may be manipulated after application of ...	Class II	Bovie Medical Corporation
Jul 18, 2016	BVX-330BR Bovie Precise 360 Handpiece 33cm, blade Product is used for th...	The adhesive may be inadequately applied or the assembly may be manipulated after application of ...	Class II	Bovie Medical Corporation
Jul 18, 2016	BVX-450NR Bovie Precise 360 Handpiece 45cm, needle Product is used for t...	The adhesive may be inadequately applied or the assembly may be manipulated after application of ...	Class II	Bovie Medical Corporation
Jun 29, 2016	TransMotion Medical, TMM5 Series Mobile Surgical Stretcher -Chair. Intende...	Non-conforming component caused arms of TMM4 Stretcher chair to no longer meet design specificati...	Class II	Winco Mfg., LLC
Jun 29, 2016	TransMotion Medical, TMM4 Series Multi-Purpose Treatment Chair. Intended u...	Non-conforming component caused arms of TMM4 Stretcher chair to no longer meet design specificati...	Class II	Winco Mfg., LLC
Jun 29, 2016	TransMotion Medical, TMM3 Series Video-Fluoroscopy Swallow Study Stretcher-Ch...	Non-conforming component caused arms of TMM4 Stretcher chair to no longer meet design specificati...	Class II	Winco Mfg., LLC
Jun 28, 2016	TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult...	Product gives incorrect low blood glucose levels.	Class II	Trividia Health
Jun 28, 2016	NIM EMG Endotracheal Tube, 6.0 mm I.D. x 8.8 mm O.D. (27 FR), Reinforced, St...	Wire in tubing can become exposed, posing potential harm to the intubated patient.	Class II	Medtronic Xomed, Inc.
Jun 28, 2016	TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult...	Product gives incorrect low blood glucose levels.	Class II	Trividia Health
Jun 28, 2016	TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult...	Product gives incorrect low blood glucose levels.	Class II	Trividia Health
Jun 28, 2016	TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult...	Product gives incorrect low blood glucose levels.	Class II	Trividia Health
Jun 24, 2016	Adaptor for Small Battery Drive and Small Battery Drive II. Product Usage:...	There was a potential for the Adaptor and Light Adaptor for Small Battery Drive and Small Battery...	Class I	The Anspach Effort, Inc.
Jun 24, 2016	Light Adaptor for Small Battery Drive and Small Battery Drive II.	There was a potential for the Adaptor and Light Adaptor for Small Battery Drive and Small Battery...	Class I	The Anspach Effort, Inc.
Jun 21, 2016	2 over 2 Elevating Monitor Suspension - Omega Medical Imaging, LLC Elevating...	Elevating Monitor Suspension separated from the lifting column bracket	Class II	Omega Medical Imaging, Inc.
Jun 15, 2016	Anspach G1 High Speed Electric Handpiece Air Cooled (eG1A) Use for cutting...	The graphics at the attachment interface indicating locked and unlocked position are reversed.	Class II	The Anspach Effort, 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.