Smiths Medical ASD Inc.

Complete recall history across all FDA and CPSC categories — 169 total recalls

Smiths Medical ASD Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (169)

FDA medical device enforcement actions by Smiths Medical ASD Inc.. Showing most recent 50.

Date Product Reason Class
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
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
Jul 18, 2024 smiths medical portex, Y' PIECE 15MM, REF 100/276/000 Uncertainty in the seal integrity of the sterile packaging. Class II
Jul 18, 2024 smiths medical portex, Nasopharyngeal Airway, Sizes as follows: a) AIRWAY ... Uncertainty in the seal integrity of the sterile packaging. Class II
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
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 ... Class I
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... Class II
Jun 26, 2024 CADD Medication Cassette Reservoir, 50mL, Product Code 21-7001-24 Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint... Class II
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... Class II
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... Class II
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... Class II
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... Class II
Jun 26, 2024 CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24 Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint... Class II
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... Class II
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... Class II
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 trac... Class I
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 trac... Class I
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 trac... Class I
May 31, 2024 Pneupac paraPAC plus 300 ventilator kit, REF P300NXX There is a potential for inadvertent tidal volume knob movement from the orig... Class I
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 patien... Class I
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 patien... Class I
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 orig... Class I
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 ... Class I
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 ... Class I
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 ... Class I
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 ... Class I
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 ... Class I
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 ... Class I
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 ... Class I
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 ... Class I
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 ... Class I
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 ... Class I
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 ... Class I
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 ... Class I
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 ... Class I
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 ... Class I
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 ... Class I
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 ... Class I
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 ... Class I
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 ... Class I
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 ... Class I
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 ... Class I
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 ... Class I
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 ... Class I
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 ... Class I
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 ... Class I
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 ... Class I
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 ... Class I
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 ... Class I
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 ... Class I

View all 169 device recalls →

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

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