Browse Device Recalls

806 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 806 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 806 FDA device recalls.

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DateProductReasonClassFirm
Mar 31, 2022 CooperSurgical H/S CATHETER SET FR 5 with Integated Stylet Model: 61-4005S ... Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment o... Class II CooperSurgical, Inc.
Mar 31, 2022 Cooper Surgical H/S ELLIPTOSPHERE CATH 5 FR Set-For administering contrast me... Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment o... Class II CooperSurgical, Inc.
Mar 31, 2022 Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr -For administering contrast media... Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment o... Class II CooperSurgical, Inc.
Jan 31, 2022 Dispensing Pins for Air Inlet Filter, Product Catalog No. 412005, DP2500 Dis... This lot may have an elevated risk of leakage from the Air-Inlet Filter of the device. Leakage of... Class II B. Braun Medical, Inc.
Jan 10, 2022 RNAstill Molecular Transport Medium Vial, Catalog number MTM-001, a component... The product does not have 510(k) clearance. Class I BASE 10 GENETICS INC
Dec 22, 2021 Trilogy Evo Repair Kit, RP-Trilogy Evo Muffler Assembly, Material Number 1135... Philips has identified a specific lot of non-conforming material manufactured by one of its suppl... Class I Philips Respironics, Inc.
Dec 22, 2021 Trilogy Evo, Material Numbers DS2110X11B (USA) and KR2110X15B (Korea) The ... Philips has identified a specific lot of non-conforming material manufactured by one of its suppl... Class I Philips Respironics, Inc.
Nov 2, 2021 The Steripath Gen2 Blood Collection System Model Number/Description 2700-... Due to an uptick of complaints associated with premature needle retraction of blood collection sy... Class II Magnolia Medical Technologies, Inc.
Aug 11, 2021 SmartPath to dStream for 1.5T-a Magnetic Resonance Medical Electrical Systems... When using manual mode, the tabletop may not completely move in or out and result in potential de... Class II Philips North America Llc
Aug 11, 2021 SmartPath to dStream for XR and 3.0T-a Magnetic Resonance Medical Electrical ... When using manual mode, the tabletop may not completely move in or out and result in potential de... Class II Philips North America Llc
Aug 2, 2021 Steripath Luer Transport Pack, Gen2, Luer, BD - Product Usage: This holder/ad... Product was shipped with the incorrect Transfer Adapter Instructions For Use (IFU). Class II Magnolia Medical Technologies, Inc.
Jul 21, 2021 DxA 5000 (DxA Automation System, DxA 5000 fit), "For in Vitro Diagnostic Use"... There is a potential that sample carriers (w or w/o samples) within automated sampling system ma... Class II Beckman Coulter Inc.
Jun 14, 2021 DreamStation ASV, DreamStation ST, AVAPS, SystemOne ASV4, C-Series ASV, C-Ser... The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the dev... Class I Philips Respironics, Inc.
Jun 14, 2021 A-Series BiPAP Hybrid A30 (not marketed in US), A-Series BiPAP V30 Auto Conti... The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the dev... Class I Philips Respironics, Inc.
Jun 14, 2021 SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, R... The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the dev... Class I Philips Respironics, Inc.
Jun 14, 2021 Philips Respironics E30 with Humidifier, Continuous Ventilator, Minimum Venti... The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the dev... Class I Philips Respironics, Inc.
Jun 14, 2021 A-Series BiPAP A 40, A-Series BiPAP A30 Continuous Ventilator, Non-life Suppo... The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the dev... Class I Philips Respironics, Inc.
Jun 14, 2021 Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators. The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the dev... Class I Philips Respironics, Inc.
May 27, 2021 ARTIS pheno- angiography systems developed for single and biplane diagnostic ... Software error VE10B -In case of a fault within the drivetrain of an axis and while performing a ... Class II Siemens Medical Solutions USA, Inc
May 1, 2021 Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - CT Vision ... Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Moni... Class II Philips North America Llc
May 1, 2021 Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - TruFligh... Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Moni... Class II Philips North America Llc
May 1, 2021 Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini ... Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Moni... Class II Philips North America Llc
May 1, 2021 Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini GX... Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Moni... Class II Philips North America Llc
May 1, 2021 Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF ... Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Moni... Class II Philips North America Llc
Mar 18, 2021 VERIGENE Processor SP - Product Usage: intended for processing and identifyin... Potential for a false-negative result for Vibrio parahaemolyticus, Salmonella, and/or Shigella sp... Class II Luminex Corporation
Mar 17, 2021 BD BBL Martin-Lewis Agar 20 Ea - Product Usage: use for the isolation of path... Products show heavy growth of C. albicans after 24 hours of incubation due to misformulation (exp... Class II Becton Dickinson & Co.
Mar 17, 2021 BD BBL Martin-Lewis Agar, 100 Ea - Product Usage: used for the isolation of ... Products show heavy growth of C. albicans after 24 hours of incubation due to misformulation (exp... Class II Becton Dickinson & Co.
Feb 25, 2021 BIOCARE Medical , IntelliPath FLX, Automated Staining Instrument, Ref: " Mod... Their is a potential that the automated staining instrument with software version 3.5.3.1 may mo... Class II Biocare Medical, LLC
Feb 9, 2021 Magellan Hypodermic Safety Needle, 25 G x 5/8" (0.508 mm x 1.6 cm). A single ... Safety shield not locking into the cannula. If the safety shield activation fails to lock a conta... Class II Cardinal Health 200, LLC
Feb 9, 2021 Magellan 3 mL Syringe with Hypodermic Safety Needle, 25 G x 5/8" (0.508 mm x ... Safety shield not locking into the cannula. If the safety shield activation fails to lock a conta... Class II Cardinal Health 200, LLC
Feb 9, 2021 McKesson PREVENT M NEEDLE (Magellan Technology) 25G X 5/8". A single lumen ... Safety shield not locking into the cannula. If the safety shield activation fails to lock a conta... Class II Cardinal Health 200, LLC
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

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.