Browse Device Recalls
791 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 791 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 791 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| 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. |
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.