Browse Device Recalls

2,437 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,437 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 2,437 FDA device recalls in 2013.

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Date	Product	Reason	Class	Firm
Nov 19, 2013	Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery Syst...	Chest Drain tubing of of the ATS Blood recovery may leak or disconnect	Class II	Atrium Medical Corporation
Nov 19, 2013	Asante Conset Infusion Set with 60cm tubing & 9mm cannula packaged in 5-packs...	Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin ...	Class II	Asante Solutions, Inc.
Nov 18, 2013	Brainlab, Spine & Trauma 3D 2.0, Navigation Software. An intraoperative imag...	The "fluoro match registration" function of the Navigation Software Spine & Trauma 3D 2.0 allows ...	Class II	Brainlab AG
Nov 18, 2013	SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 4-7 HP M.B.T. Keel P...	DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Kne...	Class II	DePuy Orthopaedics, Inc.
Nov 18, 2013	SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED Size 2-3 HP M.B....	DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Kne...	Class II	DePuy Orthopaedics, Inc.
Nov 18, 2013	SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 1-1.5 HP M.B.T. Keel...	DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Kne...	Class II	DePuy Orthopaedics, Inc.
Nov 18, 2013	SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED Size 4-7 HP M.B.T. K...	DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Kne...	Class II	DePuy Orthopaedics, Inc.
Nov 18, 2013	SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 1-1.5 HP M.B.T. K...	DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Kne...	Class II	DePuy Orthopaedics, Inc.
Nov 18, 2013	SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 2-3 HP M.B...	DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Kne...	Class II	DePuy Orthopaedics, Inc.
Nov 18, 2013	CSF-Unitized Shunt, Contoured Regular, Low Pressure, Catalog No. 46022; CSF-...	Medtronic Neurosurgery is recalling the CSF-Unitized Shunts, Delta Shunt Assembly Kit, and the St...	Class II	Medtronic Neurosurgery
Nov 18, 2013	IMPAK ACRYLIC RESIN LIQUID FOR BOTH IMPAK & IMPAK-PF POWDERS 1 qt. size (946 ...	During the current inspection of CMP Industries, the FDA Investigator discovered that the firm ha...	Class II	CMP Industries, Llc
Nov 18, 2013	Medtronic Strata II Shunt Assembly Kit, Small, Catalog No. 27848. Strata ...	Medtronic Neurosurgery is recalling the CSF-Unitized Shunts, Delta Shunt Assembly Kit, and the St...	Class II	Medtronic Neurosurgery
Nov 18, 2013	FreeStyle Lite Blood Glucose Test Strips; For in vitro diagnostic testing. ...	Certain lots of FreeStyle and FreeStyle Lite Blood Glucose Test Strips produce erroneously low bl...	Class I	Abbott Diabetes Care, Inc.
Nov 18, 2013	Medtronic Delta Shunt Assembly Kit with Bioglide Small, Performance Level 1.0...	Medtronic Neurosurgery is recalling the CSF-Unitized Shunts, Delta Shunt Assembly Kit, and the St...	Class II	Medtronic Neurosurgery
Nov 18, 2013	SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 4-7 HP M.B.T...	DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Kne...	Class II	DePuy Orthopaedics, Inc.
Nov 18, 2013	SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 1-1.5 HP M.B...	DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Kne...	Class II	DePuy Orthopaedics, Inc.
Nov 18, 2013	SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED SIZE 1-1.5 HP M.B....	DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Kne...	Class II	DePuy Orthopaedics, Inc.
Nov 18, 2013	Plan Parameters workspace within Eclipse Treatment Planning System Version 1...	An anomaly has been traced to a software deficiency within the Plan Parameters workspace. When a ...	Class II	Varian Medical Systems, Inc.
Nov 18, 2013	FreeStyle Blood Glucose Test Strips; For in vitro diagnostic testing. 50 co...	Certain lots of FreeStyle and FreeStyle Lite Blood Glucose Test Strips produce erroneously low bl...	Class I	Abbott Diabetes Care, Inc.
Nov 18, 2013	SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 2-3 HP M.B.T. Keel P...	DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Kne...	Class II	DePuy Orthopaedics, Inc.
Nov 18, 2013	SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 2-3 HP M.B.T. Kee...	DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Kne...	Class II	DePuy Orthopaedics, Inc.
Nov 18, 2013	SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 4-7 HP M.B.T. Kee...	DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Kne...	Class II	DePuy Orthopaedics, Inc.
Nov 15, 2013	Mobile X-ray System, Model: MUX-100, MUX-100H Product Usage: The device i...	Shimadzu Corporation is recalling the Shimadzu Mobile X-ray Sytems (MUX-100 and MUX-100H) because...	Class II	Shimadzu Medical Systems
Nov 15, 2013	BrainLAB's VectorVision spine is intended for use as an intraoperative image-...	Brainlab has determined that pins of thee Instrument Star Unit ML (Calibration with ICM4) with sp...	Class II	Brainlab AG
Nov 15, 2013	Large Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, ...	Firm has become aware of the potential for detachment of the jaw insert for Large Needle Drivers ...	Class II	Intuitive Surgical, Inc.
Nov 15, 2013	HemosIL Low Abnormal Control 2 UNASSAYED Part Number: 0020003220	HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval	Class II	Instrumentation Laboratory Co.
Nov 15, 2013	GE Healthcare Innova IGS 630. Biplane Cardiovascular and Interventional Imagi...	GE Healthcare has recently become aware of a potential safety issue with respect to IGS 630 Imagi...	Class II	GE Healthcare, LLC
Nov 15, 2013	HemosIL Normal Control 1 UNASSAYED Part Number: 0020003120	HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval	Class II	Instrumentation Laboratory Co.
Nov 15, 2013	Mega Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, ...	Firm has become aware of the potential for detachment of the jaw insert for Large Needle Drivers ...	Class II	Intuitive Surgical, Inc.
Nov 15, 2013	Siemens SOMATOM Definition, Definition AS, Definition Flash, and Definition ...	During clinical operation, a malfunction may occur causing a system display freeze with SOMATOM D...	Class II	Siemens Medical Solutions USA, Inc
Nov 15, 2013	HemosIL High Abnormal Control 3 UNASSAYED Part Number: 0020003320	HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval	Class II	Instrumentation Laboratory Co.
Nov 14, 2013	Renasys EZ, a Canister Component of of Renasys EZ Negative Pressure Wound Th...	Modification of the bacterial overflow guard (filter) and related changes to product labeling.	Class II	Smith & Nephew Inc.
Nov 14, 2013	VerifyNow IIb/IIIa Test, 10-Test Kit, Catalog No. 85310, 10 tests/box; 690...	Accumetrics is recalling the VerifyNow IIb/IIIa 10-Test because it contains incorrect information...	Class II	Accumetrics Inc
Nov 14, 2013	Renasys EZ PLUS, a Canister Component of of Renasys EZ Negative Pressure Wou...	Modification of the bacterial overflow guard (filter) and related changes to product labeling.	Class II	Smith & Nephew Inc.
Nov 13, 2013	Integra Small Rickham -Style Reservoir Rx Only Sterile for Single Use Only ...	Integra became aware through an adverse complaint trend that Rickham Style Reservoirs with bent o...	Class II	Integra LifeSciences Corp.
Nov 13, 2013	RTC 25-C Inline Aerosol Tee Adapter. Intended to be used to adapt an aeros...	Some packages of the RTC 25-C may have been shipped to customers with incomplete Installation and...	Class II	Instrumentation Industries Inc
Nov 13, 2013	Intubation Flexible Fiberscope, Models: 11301AA1, 11301BN1, 11302BD1, 11302BD...	KARL STORZ Endoscopy America, Inc. is recalling the Flexible Broncho Fiberscope or a Flexible Int...	Class II	Karl Storz Endoscopy America Inc
Nov 13, 2013	Broncho Flexible Fiberscope, models: 11001BN1, 11002BD1, 11004BC1, and 11009B...	KARL STORZ Endoscopy America, Inc. is recalling the Flexible Broncho Fiberscope or a Flexible Int...	Class II	Karl Storz Endoscopy America Inc
Nov 13, 2013	Integra Large Rickham -Style Reservoir Rx Only Sterile for Single Use Only ...	Integra became aware through an adverse complaint trend that Rickham Style Reservoirs with bent o...	Class II	Integra LifeSciences Corp.
Nov 13, 2013	Trevo Pro 4 Stent Retriever, Model number 80021; U.S. Indications for use: ...	Product shipped to US customers had non U.S. Instruction for use with indication for Use that wer...	Class II	Concentric Medical Inc
Nov 12, 2013	Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety...	Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond...	Class II	Ansell Sandel Medical Industries LLC
Nov 12, 2013	Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Long Disposable S...	Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond...	Class II	Ansell Sandel Medical Industries LLC
Nov 12, 2013	Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety...	Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond...	Class II	Ansell Sandel Medical Industries LLC
Nov 12, 2013	Fresenius 2008 Series Hemodialysis Machines: Models: 2008H, 2008K, 2008K2, 2...	2008 Series Hemodialysis Machines complaints of saline bags inappropriately filling during recirc...	Class II	Fresenius Medical Care Holdings, Inc.
Nov 12, 2013	Sandel Healthcare Safety Devices Weighted Safety Scalpel 4# Disposable Safety...	Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond...	Class II	Ansell Sandel Medical Industries LLC
Nov 12, 2013	Medtronic Advanced Energy Aquamantys3 Pump Generator; Product Catalog Number:...	The internal protection circuitry on the electrosurgical output that prevents a patient from expo...	Class II	Medtronic Advanced Energy, LLC
Nov 12, 2013	Zimmer Trabecular Metal Total Ankle Talar Component Left Sizes 1-6 Total a...	As part of routine manufacturing process monitoring by Zimmer, it was discovered that the Tibial ...	Class II	Zimmer, Inc.
Nov 12, 2013	Zimmer Trabecular Metal Total Ankle Talar Component Right Sizes 1-6 Total ...	As part of routine manufacturing process monitoring by Zimmer, it was discovered that the Tibial ...	Class II	Zimmer, Inc.
Nov 12, 2013	Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety...	Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond...	Class II	Ansell Sandel Medical Industries LLC
Nov 12, 2013	Zimmer Trabecular Metal Total Ankle Tibial Base Component Sizes 1-6 Total...	As part of routine manufacturing process monitoring by Zimmer, it was discovered that the Tibial ...	Class II	Zimmer, 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.