Browse Device Recalls
3,629 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,629 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 3,629 FDA device recalls, Class I.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 13, 2012 | AUTOMIX High Speed Compounder System, product 2M8077; automated nutrition com... | After fluid ingress into the keypad of the AUTOMIX Compounder's (AUTOMIX) control module, the AUT... | Class I | Baxter Healthcare Corp. |
| Jul 13, 2012 | AUTOMIX 3+3 Compounder with Accusource Monitoring System, product 2M8287; aut... | After fluid ingress into the keypad of the AUTOMIX Compounder's (AUTOMIX) control module, the AUT... | Class I | Baxter Healthcare Corp. |
| Jul 13, 2012 | AUTOMIX Plus High Speed Compounder System, product 2M8075; automated nutritio... | After fluid ingress into the keypad of the AUTOMIX Compounder's (AUTOMIX) control module, the AUT... | Class I | Baxter Healthcare Corp. |
| Jul 13, 2012 | AUTOMIX 3+3 Compounder System, product 2M8286 (115V) and 2M8286K (230V), auto... | After fluid ingress into the keypad of the AUTOMIX Compounder's (AUTOMIX) control module, the AUT... | Class I | Baxter Healthcare Corp. |
| Jul 11, 2012 | Safe Spot Infant Resuscitator, SS3200 Series, Single Patient Use, Manufacture... | Possible volume leakage through the inlet valve during compressions of the resuscitator bag. | Class I | Ventlab Corporation |
| Jul 11, 2012 | AirFlow Resuscitator, Adult Resuscitator, AF1000 Series, Single use, Manufact... | Possible volume leakage through the inlet valve during compressions of the resuscitator bag. | Class I | Ventlab Corporation |
| Jul 11, 2012 | V*Care Resuscitator Infant Resuscitator, VN 3000 Series, Single use, Manufact... | Possible volume leakage through the inlet valve during compressions of the resuscitator bag. | Class I | Ventlab Corporation |
| Jul 11, 2012 | Safe Spot Infant Resuscitator, Pro-1900 Series, Single Patient Use, The ... | Possible volume leakage through the inlet valve during compressions of the resuscitator bag. | Class I | Ventlab Corporation |
| Jul 11, 2012 | Adult Resuscitator, Pro-5000 Series, Single Patient Use, The Disposable ... | Possible volume leakage through the inlet valve during compressions of the resuscitator bag. | Class I | Ventlab Corporation |
| Jul 11, 2012 | Ventlab Rescue Med Infant Resuscitator, Manufactured by: Ventlab Corporation,... | Possible volume leakage through the inlet valve during compressions of the resuscitator bag. | Class I | Ventlab Corporation |
| Jul 11, 2012 | AirFlow, Infant Resuscitator, AF3000 Series, Single use, Manufactured by: Ven... | Possible volume leakage through the inlet valve during compressions of the resuscitator bag. | Class I | Ventlab Corporation |
| Jul 11, 2012 | Breath Tech, Safe Spot Infant Resuscitator, BT2000 Series, Single use, Manufa... | Possible volume leakage through the inlet valve during compressions of the resuscitator bag. | Class I | Ventlab Corporation |
| Jul 11, 2012 | AirFlow, Small Adult Resuscitator, AF5000 Series, Single use, Manufactured by... | Possible volume leakage through the inlet valve during compressions of the resuscitator bag. | Class I | Ventlab Corporation |
| Jul 11, 2012 | Ventlab Premium Small Child Resuscitator, Manufactured by: Ventlab Corporatio... | Possible volume leakage through the inlet valve during compressions of the resuscitator bag. | Class I | Ventlab Corporation |
| Jul 11, 2012 | Stat-Check Resuscitator, Adult Manual Emergency Resuscitator with A.C.E. /Sta... | Possible volume leakage through the inlet valve during compressions of the resuscitator bag. | Class I | Ventlab Corporation |
| Jul 11, 2012 | Ventlab Premium Small Adult Resuscitator, Manufactured by: Ventlab Corporatio... | Possible volume leakage through the inlet valve during compressions of the resuscitator bag. | Class I | Ventlab Corporation |
| Jul 5, 2012 | Synthes(R) Hemostatic Bone Putty, Part numbers 08.901.001.97S, 08.901.001.98S... | There is the potential for Hemostatic Bone Putty to ignite if contacted with electrosurgical caut... | Class I | Synthes USA HQ, Inc. |
| Jun 29, 2012 | Alaris Pump Module model 8100. Subsequent product code: FPA The Pump mo... | The recall was initiated because Carefusion identified a potential risk associated with the Alari... | Class I | CareFusion 303, Inc. |
| Jun 26, 2012 | GE Giraffe and Panda T-Piece Resuscitation System labeled ***T-Piece Neonatal... | Disposable T-Piece circuits used with resuscitation systems are unable to achieve maximum Peak In... | Class I | GE Healthcare, LLC |
| Jun 19, 2012 | CareFusion EnVe Ventilator Designed for use on patients who require respir... | CareFusion identified that the EnVe Ventilator may not hold the set Positive End Expiratory Press... | Class I | CareFusion 203, Inc. |
| Jun 15, 2012 | Alaris Pump Module Model 8100 (formerly Medley Pump Module) Subsequent Pro... | The recall was initiated because Carefusion has identified a potential risk associated with the A... | Class I | CareFusion 303, Inc. |
| Jun 8, 2012 | Neptune 1 Silver Rover, Part 0700-003-000 Stryker Instruments Neptune Rover ... | Stryker has received two reports of serious injury as a result of tissue damage associated with t... | Class I | Stryker Instruments Div. of Stryker Corporation |
| Jun 8, 2012 | Neptune Rover Waste Management System, Neptune 2 Ultra Intended for use in t... | Stryker has received two reports of serious injury as a result of tissue damage associated with t... | Class I | Stryker Instruments Div. of Stryker Corporation |
| Jun 8, 2012 | Stryker Neptune Bronze Rover, Part 0700-007-000 Neptune Bronze Rover Waste M... | Stryker has received two reports of serious injury as a result of tissue damage associated with t... | Class I | Stryker Instruments Div. of Stryker Corporation |
| Jun 8, 2012 | Neptune 1 Gold Rover (120 Vand 230V ) Waste Management System Part Number 070... | Stryker has received two reports of serious injury as a result of tissue damage associated with t... | Class I | Stryker Instruments Div. of Stryker Corporation |
| May 29, 2012 | AirLife Isothermal Breathing Circuit Accessory - Infant Patient Y Connector; ... | The Y adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ... | Class I | Carefusion 2200 Inc |
| May 29, 2012 | AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Non-Heated;... | The Y adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ... | Class I | Carefusion 2200 Inc |
| May 29, 2012 | AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Heated; an ... | The Y adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ... | Class I | Carefusion 2200 Inc |
| May 25, 2012 | Alaris PC unit model 8015 Product Usage: The device is labeled for prescr... | The recall was initiated because the Alaris PC unit model 8015 has a component on the PC unit pow... | Class I | CareFusion 303, Inc. |
| May 22, 2012 | Alere Triage CardioProfiler Panel PN 97100CP Used for the quantitative det... | Certain lots of the affected products may have significantly decreased precision relative to the ... | Class I | Alere San Diego, Inc. |
| May 22, 2012 | Alere Triage Profiler SOB Panel PN 97300 Used for the determination of cre... | Certain lots of the affected products may have significantly decreased precision relative to the ... | Class I | Alere San Diego, Inc. |
| May 22, 2012 | Triage D-dimer PN 98100 Used as an aid in the assessment and evaluation of... | Certain lots of the affected products may have significantly decreased precision relative to the ... | Class I | Alere San Diego, Inc. |
| May 22, 2012 | Alere Triage Cardiac Panel PN 97000HS Used for the quantitative determinat... | Certain lots of the affected products may have significantly decreased precision relative to the ... | Class I | Alere San Diego, Inc. |
| May 22, 2012 | Alere Triage BNP PN 98000XR Intended to be used as an aid in the diagnosis... | Certain lots of the affected products may have significantly decreased precision relative to the ... | Class I | Alere San Diego, Inc. |
| May 9, 2012 | The product has the Catalogue/Part number 60010. Olympic Cool-Cap System i... | The Olympic Cool-Cap's Control Module has experienced a frozen screen during use. When this occur... | Class I | Natus Medical Incorporated |
| May 8, 2012 | ON-Q pump with ONDEMAND bolus button, ON-Q C-bloc with ONDEMAND; ON-Q C-bloc ... | It was determined that in a small quantity of ON-Q pumps with ONDEMAND, the bolus button may not ... | Class I | I-Flow Corporation |
| May 3, 2012 | Arrow Two-Lumen Central Venous Catheterization Set with Blue FlexTip(R) ARROW... | Lidstock of product does not contain chlorhexidine contraindication and contains wording "contain... | Class I | Arrow International Inc |
| May 1, 2012 | NIDEK Medical M5C5/ MARK5 NUVO/STD, 230 V~50/60 Hz - 420 W. Oxygen Concent... | Capacitor failure may result in a fire hazard and loss of supplemental oxygen. | Class I | Nidek Medical Products Inc |
| May 1, 2012 | NIDEK Medical MARK5 NUVO 8 /OCSI, 230 V~50/60Hz - 420 W. Oxygen Concentrator. | Capacitor failure may result in a fire hazard and loss of supplemental oxygen. | Class I | Nidek Medical Products Inc |
| May 1, 2012 | NIDEK Medical MARK5 NUVO 8 STD, 115 V~60Hz - 500W. Oxygen Concentrator. | Capacitor failure may result in a fire hazard and loss of supplemental oxygen. | Class I | Nidek Medical Products Inc |
| May 1, 2012 | NIDEK Medical NUVO LITE MODEL 925 OCSI, 3LPM 230V - 60Hz - 280W. Oxygen Co... | Capacitor failure may result in a fire hazard and loss of supplemental oxygen. | Class I | Nidek Medical Products Inc |
| May 1, 2012 | NIDEK Medical M5C5/ MARK5 NUVO/OCSI, 230 V~50/60 Hz -420 W. Oxygen Concent... | Capacitor failure may result in a fire hazard and loss of supplemental oxygen. | Class I | Nidek Medical Products Inc |
| May 1, 2012 | NIDEK Medical NUVO LITE MODEL 525 OCSI, 115V -60Hz - 330W. Oxygen Concentr... | Capacitor failure may result in a fire hazard and loss of supplemental oxygen. | Class I | Nidek Medical Products Inc |
| May 1, 2012 | NIDEK Medical MARK5 NUVO / M5C5, 115 V ~60Hz - 410 W. Oxygen Concentrator. | Capacitor failure may result in a fire hazard and loss of supplemental oxygen. | Class I | Nidek Medical Products Inc |
| May 1, 2012 | NIDEK Medical NUVO LITE MODEL 925 OCSI, 230V - 50Hz - 300W. Oxygen Concent... | Capacitor failure may result in a fire hazard and loss of supplemental oxygen. | Class I | Nidek Medical Products Inc |
| May 1, 2012 | NIDEK Medical NUVO LITE MODEL 520 STD, 115V - 60Hz - 330W. Oxygen Concentr... | Capacitor failure may result in a fire hazard and loss of supplemental oxygen. | Class I | Nidek Medical Products Inc |
| Apr 29, 2012 | Flow Meter, CM Assembly, Model #27025, Serial # 13686, 13690, 13712, 13793. ... | Accutron is recalling the Flowmeter (Analgesia Gas Machine) because when it flows Nitrous Gas wit... | Class I | Accutron Inc |
| Apr 29, 2012 | CM Flowmeter Pkg H, Model #36700, Serial # 13749 Product Usage: Consc... | Accutron is recalling the Flowmeter (Analgesia Gas Machine) because when it flows Nitrous Gas wit... | Class I | Accutron Inc |
| Apr 29, 2012 | Newport Portable Package, Model #50000, Serial # 13591, 13592, 13604, 13606... | Accutron is recalling the Flowmeter (Analgesia Gas Machine) because when it flows Nitrous Gas wit... | Class I | Accutron Inc |
| Apr 29, 2012 | Ultra PC% Cabinet Mount Package G, Model #36600, Serial # 13593, 13594, 135... | Accutron is recalling the Flowmeter (Analgesia Gas Machine) because when it flows Nitrous Gas wit... | Class I | Accutron 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.