Medical devices, 2024
Shortlist up to four to read them side by side.
3,394 medical device recalls FDA’s Enforcement Report published in 2024, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 5, 2026.
3,394of 3,394 medical device recallsshown with your filters
The list
- Medical device recall smith&nephew LEGION OXINIUM POSTERIOR STABILIZED NONPOROUS FEMORAL COMPONENT, SIZE 5N, RIGHT, NARROW Complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 5N RIGHT implant instead of a GENESIS II POSTERIOR STABILIZED FEMORAL SIZE 5… Class IIFDA’s classNov 6, 2024in FDA’s Enforcement Report7 statesnamed in where it went PublishedNov 6, 2024ClassClass IIStatusOngoingWhereAlabama, California, Delaware, Georgia, Mississippi, North Carolina and Tennessee
- Medical device recall Brand Name: Vial2Bag Advanced¿ Product Name: Vial2Bag Advanced¿ 20mm Admixture Device Due to packaging damage from heat exposure during shipping/transportation that may result in a breach in the sterile barrier. Class IIFDA’s classNov 6, 2024in FDA’s Enforcement Report33 statesnamed in where it went PublishedNov 6, 2024ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Washington and Wisconsin
- Medical device recall CADD Medication Cassette Reservoir, 100mL Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall CADD Medication Cassette Reservoir, 100mL, FS Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall CADD Medication Cassette Reservoir, 100mL, FS, YELLOW Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall CADD Medication Cassette Reservoir, 50mL, FS Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall CADD Medication Cassette Reservoir, 50mL Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall CADD Medication Cassette Reservoir, 100mL, FS Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall CADD Medication Cassette Reservoir, 50mL, FS Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall ENT RES 100 ML Non-Sterile W CLAMP, TUBING FLAG, & FEMALE LUER Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall ENT RES, 100 ML, Non-Sterile W CLAMP & FEMALE LUER Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Welch Allyn Life2000 Ventilation System The Life2000 ventilator may fail to initiate the Low Gas Pressure alarm if the pressure gas source (Life2000 compressor, oxygen cylinder or wall source) is not… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall Aespire 7100, 7100 (Variant), and Aespire 7100 S/5 Protiva configurations Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall Aespire 100. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory… Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall Aespire 7900 Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall Aespire View Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall Avance. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory… Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall Amingo. OUS only. Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall Avance CS2 and Avance CS2 Pro Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall Aisys. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory… Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall Aisys CS2. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory… Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall Aisys CS2 with Et Control Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall Auxiliary Common Gas Outlet (ACGO) conversion/install kits Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall (1) Centurion Sterile CirClamp, Reorder #200CR Product has been identified as having holes in the packaging. Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Soltive Premium SuperPulsed Laser - Intended for incision, excision, resection, ablation, coagulation,… The term Bladder Stone was incorrectly translated in both Spanish and Portuguese to Kidney Stone(Clculo renal) on the systems Graphical User Interface (GUI), a… Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Soltive Pro SuperPulsed Laser Systems-Intended for incision, excision, resection, ablation, coagulation,… The term Bladder Stone was incorrectly translated in both Spanish and Portuguese to Kidney Stone(Clculo renal) on the systems Graphical User Interface (GUI), a… Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall bk3000, model #2300-11; bk3500, model #2300-41; bk5000, model #2300-61; and bkActive 2300, model #2300-66,… The internal power connections at the power inlet of the ultrasound devices can come loose resulting in the potential for excessive heat which could lead to a… Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SynchroMed II Infusion Pump Potential for error and inability to interrogate pump due to data corruption in the pump memory. Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNationwide, and Mississippi named
- Medical device recall Quantimetrix Urine Chemistry Control Set Dipper Urinalysis Dipstick Testing Levels 1 & 2 6 X 15 mL-IVD… The Quantimetrix Dipper Urinalysis Dipstick control was shipped without the validated summer packaging and may have been exposed to temperatures above 25¿C. Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNationwide, and District of Columbia named
- Medical device recall Trinias unity, Digital Angiography System with Catheterization Table If digital angiography system is used with a specific catheterization table and the operator directs simultaneous movement of the table and the C-arm using… Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNationwide, and Illinois, Kentucky, Massachusetts, Ohio, South Carolina and Tennessee named
- Medical device recall STERILIZABLE INTERNAL DEFIBRILLATION PADDLES Due to customer complaints and out of box failures, the firm is conducting a voluntary recall as a result of product failures (cracks and over-molding… Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall smiths medical portex, Nasopharyngeal Airway, Sizes as follows: a) AIRWAY NASOPHARYNGEAL 6.0MM Uncertainty in the seal integrity of the sterile packaging. Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall smiths medical portex, 15mm Double Swivel Connector: a) Uncertainty in the seal integrity of the sterile packaging. Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall smiths medical portex, Y’ PIECE 15MM Uncertainty in the seal integrity of the sterile packaging. Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall smiths medical portex, ‘ORATOR’ SPEAKING VALVE FOR TRACHEOSTOMY TUBE Uncertainty in the seal integrity of the sterile packaging. Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall smiths medical portex, Thermovent 1200, 15mm/22mm: a) Uncertainty in the seal integrity of the sterile packaging. Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Centurion PEDIATRIC/ADULT TRACHEOSTOMY T It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile… Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Centurion EP LAB INSTRUMENT KIT It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile… Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Centurion brand, medical procedure convenience kits, labeled as: a) FLOOR - UMBILICAL CUT DOWN TRA, b)… It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile… Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Centurion OB TRAY It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile… Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline CV ANESTHESIA - ROOM SET UP It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile… Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline brand medical procedure convenience kit, labeled as: a) PAIN PROCEDURE PACK It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile… Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline brand, medical procedure convenience kits, labeled as: a) SET UP PACK It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile… Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline brand, medical procedure convenience kits, labeled as: a) RADIOLOGY LP TRAY It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile… Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline brand, medical procedure convenience kits, labeled as: a) CUH OPEN HEART A B C - CDS It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile… Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline brand medical procedure convenience kits, labeled as: a) KIT LINE INSERTION It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile… Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline brand medical procedure convenience kits, labeled as: a) CONE BIOPSY PACK It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile… Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline DENTAL PACK It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile… Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNationwide
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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