Browse Device Recalls

179 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 179 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 179 FDA device recalls.

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DateProductReasonClassFirm
Jul 18, 2024 smiths medical portex, 15mm Double Swivel Connector: a) REF 100/255/150; ... Uncertainty in the seal integrity of the sterile packaging. Class II Smiths Medical ASD Inc.
Jul 18, 2024 smiths medical portex, Thermovent 1200, 15mm/22mm: a) REF 100/582/000; b) RE... Uncertainty in the seal integrity of the sterile packaging. Class II Smiths Medical ASD Inc.
Jul 18, 2024 smiths medical portex, Y' PIECE 15MM, REF 100/276/000 Uncertainty in the seal integrity of the sterile packaging. Class II Smiths Medical ASD Inc.
Jul 18, 2024 smiths medical portex, Nasopharyngeal Airway, Sizes as follows: a) AIRWAY ... Uncertainty in the seal integrity of the sterile packaging. Class II Smiths Medical ASD Inc.
Jul 18, 2024 smiths medical portex, 'ORATOR' SPEAKING VALVE FOR TRACHEOSTOMY TUBE, REF 100... Uncertainty in the seal integrity of the sterile packaging. Class II Smiths Medical ASD Inc.
Jul 16, 2024 CADD-Solis Li-ion Rechargeable Battery Packs, REF 21-2160-XX, which are also ... Damage to the battery pack may have caused a short to a capacitor within the battery pack. While... Class I Smiths Medical ASD Inc.
Jun 26, 2024 CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24JP Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medicat... Class II Smiths Medical ASD Inc.
Jun 26, 2024 CADD Medication Cassette Reservoir, 50mL, Product Code 21-7001-24 Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medicat... Class II Smiths Medical ASD Inc.
Jun 26, 2024 CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24 Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medicat... Class II Smiths Medical ASD Inc.
Jun 26, 2024 CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24 Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medicat... Class II Smiths Medical ASD Inc.
Jun 26, 2024 CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24 Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medicat... Class II Smiths Medical ASD Inc.
Jun 26, 2024 ENT RES 100 ML Non-Sterile W CLAMP, TUBING FLAG, & FEMALE LUER, Product Code... Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medicat... Class II Smiths Medical ASD Inc.
Jun 26, 2024 CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24 Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medicat... Class II Smiths Medical ASD Inc.
Jun 26, 2024 ENT RES, 100 ML, Non-Sterile W CLAMP & FEMALE LUER, Product Code 68-2231-28 Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medicat... Class II Smiths Medical ASD Inc.
Jun 26, 2024 CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24JP Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medicat... Class II Smiths Medical ASD Inc.
Jun 7, 2024 smiths medical portex BLUgriggs Percutaneous Dilation Procedural Trays with B... There is the potential for a disconnection of the pilot balloon from the tracheostomy inflation l... Class I Smiths Medical ASD Inc.
Jun 7, 2024 smiths medical portex BLUperc Percutaneous Diliation Procedural Trays with BL... There is the potential for a disconnection of the pilot balloon from the tracheostomy inflation l... Class I Smiths Medical ASD Inc.
Jun 7, 2024 smiths medical portex BLUselect, tracheostomy tube, labeled as follows: 1) ... There is the potential for a disconnection of the pilot balloon from the tracheostomy inflation l... Class I Smiths Medical ASD Inc.
May 31, 2024 Pneupac paraPAC plus 300 ventilator kit, REF P300NXX There is a potential for inadvertent tidal volume knob movement from the original setting when se... Class I Smiths Medical ASD Inc.
May 31, 2024 paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N Smiths Medical became aware of an issue related to a potential for the patient outlet connector t... Class I Smiths Medical ASD Inc.
May 31, 2024 paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N Smiths Medical became aware of an issue related to a potential for the patient outlet connector t... Class I Smiths Medical ASD Inc.
May 31, 2024 Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NXX There is a potential for inadvertent tidal volume knob movement from the original setting when se... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM UNCUFFED NEONA... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHE... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS PEDIATRIC TRA... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOM... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 6.0MM FLEXTEND PEDIA... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY ... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOS... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOM... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: TTS NEONATAL TRACHY ... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEO... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOS... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND NE... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) AIRE-CUF TRACHY T... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM AIRE-CUF NEONA... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOS... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOM... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5mm TTS CUFFED ... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS NEONATAL TRAC... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOS... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACH TU... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND PE... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEO... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 4.0MM FLEXTEND PE... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOS... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5 UNCUFFED NEON... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM PEDIATRIC UNCU... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT NECK , Product Cod... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOM... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD 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.