Browse Device Recalls

774 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 774 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 774 FDA device recalls.

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Date	Product	Reason	Class	Firm
Jan 22, 2021	ACIST Kodama Intravascular Ultrasound Catheter The Kodama Intravascular U...	Test results from the manufacturing line found a piece of damaged o-ring in an unexpected section...	Class I	Acist Medical Systems
Jan 15, 2021	ConMed 50L abdominal insufflator, Catalog Number 72-00258-0 / GS2000 - Produc...	An internal tubing component in the flow path was made with incorrect material which was not test...	Class II	Northgate Technologies, Inc.
Jan 15, 2021	Steris CO2MPACT Endoscopic Insufflator system, Catalog Number 72-00310-0 / 71...	An internal tubing component in the flow path was made with incorrect material which was not test...	Class II	Northgate Technologies, Inc.
Nov 23, 2020	uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871...	When a user creates a measurement tool annotation in the uPath Enterprise software version 1.1, t...	Class II	Roche Molecular Systems, Inc.
Oct 30, 2020	Verigene Enteric Pathogens Nucleic Acid Test (EP) Model Number: 20-006-023	Potential for a false-negative result.	Class II	Luminex Corporation
Oct 30, 2020	Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) Model Number:...	Potential for a false-negative result.	Class II	Luminex Corporation
Oct 23, 2020	Box Label: ION Fully Articulating Catheter, REF 490105, VER 08 - Product Usag...	The distal tip ring of the fully articulating catheter may become dislodged during the procedure.	Class II	Intuitive Surgical, Inc.
Oct 8, 2020	MEDICREA LIGAPASS TENSION PULLEY HANDLE XS- intended to provide thoracic and...	Tightening the LIGAPASS Band with this instrument, the tensioner's pliers can crush the band caus...	Class II	Medicrea International
Sep 21, 2020	DePuy Synthes SYNMESH 10MM DIA 18MM HEIGHT (TI) Product Number: 495.344 - Pr...	Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG...	Class III	Synthes (USA) Products LLC
Sep 21, 2020	STANDARD RING 22MM X 28MM (TI) Product Number: 495-406 - Product Usage: is a...	Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG...	Class III	Synthes (USA) Products LLC
Sep 21, 2020	END RING 22MM X 28MM LATERAL OR ANTERIOR/0 DEG (TI) Product Number: 495-396 ...	Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG...	Class III	Synthes (USA) Products LLC
Sep 21, 2020	END RING 17MM X 22MM LATERAL OR ANTERIOR/0 DEG (TI) Product Number: 495.392 ...	Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG...	Class III	Synthes (USA) Products LLC
Sep 21, 2020	END RING 12MM DIA/0 DEG (TI) Product Number: 495.385 - Product Usage: is a v...	Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG...	Class III	Synthes (USA) Products LLC
Sep 21, 2020	SYNMESH 17MM X 22MM 88MM HEIGHT (TI) Product Number: 495-374 - Product Usag...	Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG...	Class III	Synthes (USA) Products LLC
Sep 21, 2020	END RING 10MM DIA/0 DEG (TI) Product Number: 495.384 - Product Usage: is a v...	Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG...	Class III	Synthes (USA) Products LLC
Sep 21, 2020	SYNMESH 15MM DIA 88MM HEIGHT (TI) Product Number: 495.366 - Product Usage: ...	Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG...	Class III	Synthes (USA) Products LLC
Sep 21, 2020	SYNMESH 12MM DIA 88MM HEIGHT (TI) Product Number: 495.357 - Product Usage: ...	Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG...	Class III	Synthes (USA) Products LLC
Sep 21, 2020	3.0MM LOCKING SCREW LOW PROFILE (TI) Product Number: 495-491 - Product Usag...	Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG...	Class III	Synthes (USA) Products LLC
Sep 21, 2020	END RING 15MM DIA/0 DEG (TI) Product Number: 495.386 - Product Usage: is a v...	Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG...	Class III	Synthes (USA) Products LLC
Sep 21, 2020	STANDARD RING 17MM X 22MM (TI) Product Number: 495-405 - Product Usage: is a ...	Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG...	Class III	Synthes (USA) Products LLC
Sep 21, 2020	Revolution Apex, Revolution CT with Apex Edition, Model 5995000-5 - Product U...	There is a potential for a smudge artifact that could be suspect for pathology in some images due...	Class II	GE Healthcare, LLC
Sep 21, 2020	SYNMESH¿ 22MM X 28MM 88MM HEIGHT (TI) Product Number: 495.379 - Product Usa...	Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG...	Class III	Synthes (USA) Products LLC
Sep 21, 2020	END RING 22MM X 28MM LATERAL OR ANTERIOR/5 DEG (TI) Product Number: 495-398 ...	Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG...	Class III	Synthes (USA) Products LLC
Sep 21, 2020	END RING 17MM X 22MM LATERAL OR ANTERIOR/5 DEG (TI) Product Number: 495.394 ...	Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG...	Class III	Synthes (USA) Products LLC
Aug 31, 2020	Spinning Spiros, Closed Male Luer, REF: 060-CH2000S; SURPLUG ChemoAccess Clos...	Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea...	Class II	ICU Medical, Inc.
Aug 31, 2020	3mL Syringe w/Spinning Spiros, Red Cap, REF: CH2003; 5mL Syringe w/Spinning S...	Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea...	Class II	ICU Medical, Inc.
Aug 31, 2020	31" (78 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chambe...	Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea...	Class II	ICU Medical, Inc.
Aug 31, 2020	Spinning Spiros Closed Male Luer, Red Cap, REF: IB-CH2000SC; 5" (13 cm) Appx ...	Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea...	Class II	ICU Medical, Inc.
Aug 31, 2020	30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, S...	Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea...	Class II	ICU Medical, Inc.
Aug 31, 2020	76 cm (30") Appx 3.3 ml, Admin Set, 2 Spiros w/Red Cap, 20 Drop In-Line Drip ...	Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea...	Class II	ICU Medical, Inc.
Aug 31, 2020	Appx 1.7 ml Bag Spike w/Integrated Clave, 2 Drop-In Spiros, REF: CH3260	Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea...	Class II	ICU Medical, Inc.
Aug 31, 2020	5 IN (13 cm) Appx 1.5 ml, Bag Spike Adapter, Spiros, REF: 20123-01; 75" (191 ...	Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea...	Class II	ICU Medical, Inc.
Aug 31, 2020	30" (76 cm) Appx 5.5 mL 20 Drop Admin Set w/Integrated Clave Drip Chamber, 1...	Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea...	Class II	ICU Medical, Inc.
Aug 31, 2020	Spiros CLOSED MALE LUER w/RED CAP, 25 UNITS, REF: 011-CH2000SC-25; 76 cm (30"...	Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea...	Class II	ICU Medical, Inc.
Aug 31, 2020	42 IN (107 cm) Appx 5.0 ml, 20 Drop Admin Set, Spiros, REF: 20131-01; 31" (79...	Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea...	Class II	ICU Medical, Inc.
Aug 31, 2020	26 IN(66 cm) APPX 3.4ml, 10 DROP BLOOD SET, 170 MICRON FILTER, Spiros, REF: Z...	Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea...	Class II	ICU Medical, Inc.
Aug 31, 2020	30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w/Integrated ChemoLock Drip Chambe...	Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea...	Class II	ICU Medical, Inc.
Aug 24, 2020	Opticross 35 15 MHz Peripheral Imaging Catheter 8F (2.74 mm) X 105 cm Expirat...	Opticross 35 Peripheral Imaging Catheter is being recalled because the incremental telescoping le...	Class II	Boston Scientific Corporation
Aug 13, 2020	Critical Care Decontamination System (CCDS) Compatible N95 respirators - Pr...	Masks processed at one site were not maintained at levels of condensation during a portion of the...	Class II	Battelle Memorial Institute
Aug 6, 2020	The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretiv...	COVID-19 Interpretive Software issues that may cause: 1) the risk of invalid or inconclusive tes...	Class II	Life Technologies Corporation
Aug 6, 2020	The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretiv...	COVID-19 Interpretive Software issues that may cause: 1) the risk of invalid or inconclusive tes...	Class II	Life Technologies Corporation
Jul 24, 2020	Barricaid Annual Closure Device (ACD) BAR-A8-8MM - Product Usage: The Barrica...	The catalog ( REF ) number on the peelable inner labels (patient sticker) that is on the inner co...	Class II	Intrinsic Therapeutics, Inc.
Jul 6, 2020	7" (18 cm) Appx 0.32 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/Rem...	Identification of a potential manufacturing defect on the internal surface of the NanoClave wit...	Class II	ICU Medical, Inc.
Jul 6, 2020	9.5" (24 cm) Appx 0.45 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/M...	Identification of a potential manufacturing defect on the internal surface of the NanoClave wit...	Class II	ICU Medical, Inc.
Jul 6, 2020	7" (18 cm) Appx 0.31 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv...	Identification of a potential manufacturing defect on the internal surface of the NanoClave wit...	Class II	ICU Medical, Inc.
Jul 6, 2020	6.5" (17 cm) Appx 0.30 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Re...	Identification of a potential manufacturing defect on the internal surface of the NanoClave wit...	Class II	ICU Medical, Inc.
Jul 6, 2020	6.5" (17 cm) Appx 0.35 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/R...	Identification of a potential manufacturing defect on the internal surface of the NanoClave wit...	Class II	ICU Medical, Inc.
Apr 22, 2020	ARTIS Pheno - Interventional Fluoroscopic X-Ray System Model: 10849000 - Pro...	If the C-arm leaves its intended travel path due to a fault within the drivetrain, movements may ...	Class II	Siemens Medical Solutions USA, Inc
Apr 17, 2020	Extremities Item Number: 1)113954 Hybrid Glenoid Glenoid Base, 4 MM 2) XL...	Potential presence of elevated endotoxin levels that exceed the specification limit	Class II	Biomet, Inc.
Apr 3, 2020	Philips Azurion 7 M20 -XperGuide Software hosted in Interventional Workspot 1...	When a user acquires XperCT scan on an Azurion 2.0 system, enters the XperGuide guidance step and...	Class II	Philips North America, 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.