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 25, 2020	Equinoxe Platform Fracture Stem, 6.5mm, Right - Product Usage: The Equinoxe P...	The device may be incorrectly laser marked as a right stem, when it should have been laser marked...	Class II	Exactech, Inc.
Sep 25, 2020	Equinoxe Platform Fracture Stem, 6.5mm, Left - Product Usage: The Equinoxe Pl...	The device may be incorrectly laser marked as a right stem, when it should have been laser marked...	Class II	Exactech, Inc.
Sep 17, 2020	A Li-Gator Single Use Laparoscopic Clip Applier, 10 mm X 29 cm - Product Usag...	Device malfunction causing the applier to jam, and clip loading failures.	Class II	Genicon, Inc.
Sep 14, 2020	MR Coils The MR Coil is intended to be used in conjunction with a Magnetic...	The labels have been mistakenly printed with an IPX1 rating symbol. IPX ratings relate to protect...	Class III	Invivo Corporation
Sep 4, 2020	B. Braun Introcan IV Safety Catheters, sterile - Product Usage: It is a singl...	Recalled products do not have FDA approval for sale in the United States.	Class II	Braxton Medical Corporation
Aug 31, 2020	CERTAIN BELLATEK TIN ABUTMENT 5.0MM Reference Number: IEDAN5	Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing...	Class II	Biomet 3i, LLC
Aug 31, 2020	CERTAIN BELLATEK TITANIUM ABUTMENT 6.0MM Reference Number: IEDAT6	Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing...	Class II	Biomet 3i, LLC
Aug 31, 2020	BellaTek Encode Defin3DPMSERitive Abutments-3D Printed Model Reference Numbe...	Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing...	Class II	Biomet 3i, LLC
Aug 31, 2020	CERTAIN BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: IEDAT4	Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing...	Class II	Biomet 3i, LLC
Aug 31, 2020	CERTAIN BELLATEK TIN ABUTMENT 4.1MM Reference Number: IEDAN4	Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing...	Class II	Biomet 3i, LLC
Aug 31, 2020	CERTAIN BELLATEK TITANIUM ABUTMENT 5.0MM Reference Number: IEDAT5	Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing...	Class II	Biomet 3i, LLC
Aug 31, 2020	BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: EDAT4	Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing...	Class II	Biomet 3i, LLC
Aug 25, 2020	Aquas PowerFlow Tube Set - Product Usage: The device delivers sterile irrigat...	The product design incorporating a motor driven impeller pump powered by one 9V alkaline battery ...	Class II	Genicon, Inc.
Aug 24, 2020	Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 18 mm.	Exactech is recalling the Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit, because it...	Class II	Exactech, Inc.
Aug 24, 2020	Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm.	Exactech is recalling the Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit, because it...	Class II	Exactech, Inc.
Aug 10, 2020	The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm.	The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm, were found to have a l...	Class II	Exactech, Inc.
Jul 27, 2020	JINYINSHAN, KN95 PROTECTIVE MASK P1, 20 pieces	Test results revealed that the KN95 masks failed to filter greater than 95% of particulates.	Class II	Office Depot Inc
Jul 21, 2020	Ezycare Face Mask, Disposable Non Medical Face Masks - Product Usage: markete...	Disposable face masks labeled as non-medical were distributed to customers expecting medical use ...	Class II	BEYOND WHITE SPA LLC D.B.A. EZYWIPE OF AMERCIA
Jul 15, 2020	StimQ Peripheral Nerve Stimulator System (PNS) Model STQ4-SPR-BO US - Product...	The product contains a non-functional component not referenced in product labeling.	Class II	Stimwave Technologies Inc
Jul 15, 2020	StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-TRL-BO US and...	The product contains a non-functional component not referenced in product labeling.	Class II	Stimwave Technologies Inc
Jul 15, 2020	StimQ Peripheral Nerve Stimulator System (PNS) Model 1. STQ4-RCV-A0 US and 2....	The product contains a non-functional component not referenced in product labeling.	Class II	Stimwave Technologies Inc
Jul 15, 2020	StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-RCV-AO US and...	The product contains a non-functional component not referenced in product labeling.	Class II	Stimwave Technologies Inc
Jul 15, 2020	StimQ Peripheral Nerve Stimulator System (PNS) Model FR4A-TRL-AO US - Product...	The product contains a non-functional component not referenced in product labeling.	Class II	Stimwave Technologies Inc
Jul 15, 2020	StimQ Peripheral Nerve Stimulator System (PNS) Models FR4A-SPR-BO US - Produc...	The product contains a non-functional component not referenced in product labeling.	Class II	Stimwave Technologies Inc
Jul 9, 2020	Mako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:008484860...	Characterization issue associated with the product. This issue may cause a discrepancy during bo...	Class II	Mako Surgical Corporation
Jul 8, 2020	M-Close Kit, REF 27-101; a disposable, ligature passing, suturing apparatus a...	The plastic housing on the device may fracture	Class II	New Wave Endo-Surgical, Corp.
Jun 24, 2020	Sterile Low Profile Screw, Titanium, 6.7 x 65mm Part Number: AR-8967-2865S -...	Screws provided in packaging are 5mm shorter than intended	Class II	Arthrex, Inc.
Jun 18, 2020	Anjon Bremer Molded Crown. bone fixation fastener for spinal use. REF number...	High rate of galling of one threaded component.	Class II	Anjon Holdings
Jun 12, 2020	Software 1898072 IPC upgrade v 2.7.3.0 - Product Usage: The IPC system is ind...	During internal testing execution of the next generation of Integrated Power Console (IPC) protot...	Class II	Medtronic Xomed, Inc.
Jun 9, 2020	enVista one-piece hydrophobic acrylic toric intraocular lens, Bausch and Lomb...	The toric axis marks were misaligned (from the expected position in relation to the haptics) on a...	Class II	Bausch & Lomb Surgical, Inc.
May 14, 2020	Biomet 6.5 Cannulated Screw Tap - Bone fixation screw, Item Number: 110008...	Distributed to the field without having completed design history files or design transfer activities	Class II	Biomet
May 14, 2020	A.L.P.S.¿ PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE LEFT 14 HOLE 227MM, Item...	Distributed to the field without having completed design history files or design transfer activities	Class II	Biomet
May 14, 2020	A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE RIGHT 7 HOLE 140MM, Item...	Distributed to the field without having completed design history files or design transfer activities	Class II	Biomet
May 14, 2020	A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE RIGHT 14 HOLE 227MM, Item...	Distributed to the field without having completed design history files or design transfer activities	Class II	Biomet
May 14, 2020	A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE LEFT 14 HOLE 234MM, Item...	Distributed to the field without having completed design history files or design transfer activities	Class II	Biomet
May 14, 2020	A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM DRILL BLOCK GUIDE SLEEVE 2.7MM, Ite...	Distributed to the field without having completed design history files or design transfer activities	Class II	Biomet
May 14, 2020	DRW-0742-01: Gen 2 Anterior Chairside Splint LLUR (lower left-upper right) - ...	The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled.	Class II	Neocis Inc.
May 14, 2020	A.L.P.S.¿ PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 14...	Distributed to the field without having completed design history files or design transfer activities	Class II	Biomet
May 14, 2020	A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE RIGHT 11 HOLE 197MM, Ite...	Distributed to the field without having completed design history files or design transfer activities	Class II	Biomet
May 14, 2020	A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM DRILL BLOCK SET SCREW, Item Number:...	Distributed to the field without having completed design history files or design transfer activities	Class II	Biomet
May 14, 2020	A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE LEFT 11 HOLE 197MM, Item...	Distributed to the field without having completed design history files or design transfer activities	Class II	Biomet
May 14, 2020	A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE RIGHT 11 HOLE 190MM, Item...	Distributed to the field without having completed design history files or design transfer activities	Class II	Biomet
May 14, 2020	DRW-0739-01: Gen 2 Posterior Chairside Splint LLUR (lower left-upper right) -...	The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled.	Class II	Neocis Inc.
May 14, 2020	A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 234...	Distributed to the field without having completed design history files or design transfer activities	Class II	Biomet
May 14, 2020	Biomet 8.0 Cannulated Screw Tap-Bone fixation screw Item Number: 110008467 -...	Distributed to the field without having completed design history files or design transfer activities	Class II	Biomet
May 14, 2020	A.L.P.S. T15 LOW PROFILE CORTICAL SCREW 3.5mm x 28mm, Item Number: 110017628...	Distributed to the field without having completed design history files or design transfer activities	Class II	Biomet
May 14, 2020	A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE LEFT 7 HOLE 140MM, Item ...	Distributed to the field without having completed design history files or design transfer activities	Class II	Biomet
May 14, 2020	A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM 3.2MM CALIBRATED DRILL BIT, Item Nu...	Distributed to the field without having completed design history files or design transfer activities	Class II	Biomet
May 14, 2020	A.L.P.S.¿ PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE LEFT 11 HOLE 190MM, Item...	Distributed to the field without having completed design history files or design transfer activities	Class II	Biomet
May 14, 2020	A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE RIGHT 14 HOLE 234MM, Ite...	Distributed to the field without having completed design history files or design transfer activities	Class II	Biomet

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.