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Smiths Medical ASD Inc.
Smiths Medical ASD Inc.: 293 FDA recall reports
Every medical device recall the FDA has published for Smiths Medical ASD Inc.. The fault, and how the agency graded it.
293Reports
84Class I
143Ongoing
2025-05-14Most recent
84 Class I on this pageClass I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Class I
CADD-Solis HPCA Ambulatory Infusion Pump; Model/Number: 21-2111-0402-09-KYO 21-2111-0402-09-KYO CADD SOLIS P
Z-1667-2025 · Class I · reported 2025-05-14 · Ongoing
- Why it was recalled
- Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.
- Product
- CADD-Solis HPCA Ambulatory Infusion Pump; Model/Number: 21-2111-0402-09-KYO 21-2111-0402-09-KYO CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP 21-2111-0300-09_LOAN CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR CMSA 21-2111-0300-09_CMSA CADD Solis PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR FUKUOKA 21-2111-0300-09_FUK CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR KYOTO 21-2111-0300-09_KYO CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR OKAYAMA 21-2111-0300-09_OKA CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR OOMIYA 21-2111-0300-09_OMI CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR OSAKA 21-2111-0300-09_OSA CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR SAPPORO 21-2111-0300-09_SAP CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR TOKYO 21-2111-0300-09_TOK CADD_SOLIS_MODEL 2110_ENGLISH_1/EA 21-2111-0200-50JP CADD-Solis VIP CADD-SOLIS V4.2 LOAN FUK 21-2111-0402-09-FUK CADD-SOLIS V4.2 LOAN NAG 21-2111-0402-09-NAG CADD-SOLIS V4.2 LOAN OKA 21-2111-0402-09-OKA CADD-SOLIS V4.2 LOAN OSA 21-2111-0402-09-OSA CADD-SOLIS V4.2 LOAN SAI 21-2111-0402-09-SAI CADD-SOLIS V4.2 LOAN SAP 21-2111-0402-09-SAP...
- Where it went
- Worldwide - US nationwide distribution.
- How much
- 185,975 US; 127,701 OUS Total
Class I
CADD-Solis VIP Ambulatory Infusion Pump; Model/Number: 21-2120-0100-02 21-2120-0100-03 21-2120-0100-06
Z-1668-2025 · Class I · reported 2025-05-14 · Ongoing
- Why it was recalled
- Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.
- Product
- CADD-Solis VIP Ambulatory Infusion Pump; Model/Number: 21-2120-0100-02 21-2120-0100-03 21-2120-0100-06 21-2120-0100-232 21-2120-0100-233 21-2120-0100-50 21-2120-0100-51 21-2120-0100-95 21-2120-0102-02 21-2120-0102-03 21-2120-0102-06 21-2120-0102-07 21-2120-0102-08 21-2120-0102-12 21-2120-0102-13 21-2120-0102-14 21-2120-0102-15 21-2120-0102-17 21-2120-0102-237 21-2120-0102-238 21-2120-0102-247 21-2120-0102-249 21-2120-0102-51 21-2120-0102-78 21-2120-0102-92 21-2120-0102-97 21-2120-0102-98 21-2120-0103-01 21-2120-0103-02 21-2120-0103-03 21-2120-0103-06 21-2120-0103-07 21-2120-0103-08 21-2120-0103-12 21-2120-0103-14 21-2120-0103-15 21-2120-0103-17 21-2120-0103-249 21-2120-0103-51 21-2120-0103-78 21-2120-0104-01 21-2120-0104-231 21-2120-0105-00 21-2120-0105-01 21-2120-0105-02L 21-2120-0105-03L 21-2120-0105-06L 21-2120-0105-07L 21-2120-0105-08 21-2120-0105-08L 21-2120-0105-12L 21-2120-0105-13L 21-2120-0105-14L 21-2120-0105-15L 21-2120-0105-17L 21-2120-0105-50 21-2120-0105-50L 21-2125-0104-01 21-2125-0105-03L 21-2125-0105-07L 21-2125-0105-08L 21-2125-0105-50L 21-2127-0104-01 21-2127-0105-01 21-2127-0105-02L ...
- Where it went
- Worldwide - US nationwide distribution.
- How much
- 185,975 US; 127,701 OUS Total
Class I
CADD Solis VIP Ambulatory Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, MANUAL
Z-1682-2025 · Class I · reported 2025-05-14 · Ongoing
- Why it was recalled
- There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.
- Product
- CADD Solis VIP Ambulatory Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, MANUAL MODE, 1/EA, Model Number: 21-2127-0105-01; 2) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, PHARMGUARD ENABLED, 1/EA, Model Number: 21-2120-0105-01; 3) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH 1/EA, Model Number: 21-2120-0103-01; 4) PUMP, CADD-SOLIS VIP, MDL 2120, ENGLISH 1/EA, Model Number: 21-2120-0102-51; 5) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, PHARMGUARD ENABLED 1/EA, Model Number: 21-2120-0104-01; 6) PUMP KIT, CADD-SOLIS VIP, MDL 2120, CE GLOBAL ENGLISH 1/EA, Model Number: 21-2120-0103-51; 7) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, MANUAL MODE 1/EA, Model Number: 21-2127-0104-01; 8) PUMP KIT, CADD-SOLIS VIP, MDL 2120, TRIAL/LOANER, NA ENGLISH, PHARMGUARD, 1/EA, Model Number: 21-2120-0105-00; 9) PUMP, CADD-SOLIS VIP, MDL 2120, TRIAL/LOANER CE GLOBAL ENGLISH 1/EA, Model Number: 21-2120-0103-78; 10) PUMP, CADD-SOLIS VIP, MDL 2120, ENGLISH, TRIAL/LOANER 1/EA, Model Number: 21-2120-0102-78; 11) PUMP, CADD-SOLIS VIP, MDL 2120, NFHU, NA ENGLISH, PHARMGUARD ENABLED 1/EA, Model Number:...
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- 313,676 items
Class I
CADD-Solis Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, CE ENGLISH 1/EA, Model Numbe
Z-1681-2025 · Class I · reported 2025-05-14 · Ongoing
- Why it was recalled
- There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.
- Product
- CADD-Solis Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, CE ENGLISH 1/EA, Model Number: 21-2111-0402-51; 2) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, YELLOW, CE ENGLISH 1/EA, Model Number: 21-2112-0402-51; 3) PUMP KIT, CADD-SOLIS, YELLOW, MODEL 2110 1/EA, Model Number: 21-2112-0100-51; 4) PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW KEYPAD, MODEL 2110, NA ENGLISH 1/EA, Model Number: 21-2112-0300-01; 5) PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, NA ENGLISH 1/EA, Model Number: 21-2111-0300-01; 6) PUMP KIT, CADD-SOLIS, MDL 2110, V4.1, CE ENGLISH 1/EA, Model Number: 21-2111-0401-51; 7) PUMP KIT, CADD-SOLIS, MODEL 2110, CE ENGLISH 1/EA, Model Number: 21-2111-0100-51; 8) PUMP KIT, CADD-SOLIS, MDL 2110, V4.1, YELLOW, CE ENGLISH 1/EA, Model Number: 21-2112-0401-51; 9) PUMP KIT, CADD-SOLIS, MDL 2100, CE ENGLISH 1/EA, Model Number: 21-2101-51; 10) PUMP KIT, CADD-SOLIS, MDL 2110, V4.0, CE ENGLISH 1/EA, Model Number: 21-2111-0400-51; 11) PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, OUS ENGLISH 1/EA, Model Number: 21-2111-0300-50; 12) PUMP, TRIAL/LOANER, CADD- SOLIS, MODEL 2100 1/EA, Model Number:...
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- 313,676 total units
Class I
CADD Solis HSPCA Pump ***Updated 5/27/26*** Scope updated to apply specifically to customers using the wirele
Z-1662-2025 · Class I · reported 2025-05-14 · Ongoing
- Why it was recalled
- Pumps may experience Wireless Connection Modules intermittent connection alarms, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.
- Product
- CADD Solis HSPCA Pump ***Updated 5/27/26*** Scope updated to apply specifically to customers using the wireless system. Affected products associated with the change in scope: PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, ENGLISH, 1/EA 21-2111-0403-51 PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, TRIAL, LOANER, ENGLISH, 1/EA 21-2111-0403-78 PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, YELLOW, ENGLISH, 1/EA 21-2112-0403-51 PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, YELLOW, FRENCH, 1/EA 21-2112-0403-02 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, NA ENGLISH 1/EA ¿ 21-2111-0300-01 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, OUS ENGLISH 1/EA ¿ 21-2111-0300-50 PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW KEYPAD, MODEL 2110, NA ENGLISH 1/EA ¿ 21-2112-0300-01 PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW, MODEL 2110, FRENCH 1/EA ¿ 21-2112-0300-02 PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW, MODEL 2110, OUS ENGLISH 1/EA 21-2112-0300-50 PUMP KIT, CADD-SOLIS, MDL 2100, CE ENGLISH 1/EA ¿ 21-2101-51 PUMP KIT, CADD-SOLIS, MDL 2110, TRIAL/LOANER, V4.1, CE ENGLISH 1/EA 21-2111-0401-78 PUMP KIT, CADD-SOLIS, MDL 2110, TRIAL/LOANER, V4.2, CE ENGLISH 1/EA ¿ 21-2111-0402-78 PUMP KIT, CADD-SOLIS, MDL 2110, v4.0, ENGLISH 1/EA...
- Where it went
- Worldwide - US Nationwide distribution.
- How much
- US: 83,833 items ; OUS: 71,843 items
Class I
smiths medical ProPort Plastic Venous Access System, Implantable Venous Access Systems, 82-24
Z-1286-2025 · Class I · reported 2025-03-26 · Ongoing
- Why it was recalled
- The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
- Product
- smiths medical ProPort Plastic Venous Access System, Implantable Venous Access Systems, 82-24
- Where it went
- Worldwide distribution.
- How much
- 0 units
Class I
smiths medical ProPort Low Profile Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr)
Z-1287-2025 · Class I · reported 2025-03-26 · Ongoing
- Why it was recalled
- The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
- Product
- smiths medical ProPort Low Profile Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm., 6Fr Introducer, REF 21-4183-24
- Where it went
- Worldwide distribution.
- How much
- 8515 units
Class I
smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm
Z-1285-2025 · Class I · reported 2025-03-26 · Ongoing
- Why it was recalled
- The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
- Product
- smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introducer, REF 21-4173-24
- Where it went
- Worldwide distribution.
- How much
- 12 units
Class I
smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm
Z-1284-2025 · Class I · reported 2025-03-26 · Ongoing
- Why it was recalled
- The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
- Product
- smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., REF 21-4172-24
- Where it went
- Worldwide distribution.
- How much
- 1 unit
Class I
smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm
Z-1282-2025 · Class I · reported 2025-03-26 · Ongoing
- Why it was recalled
- The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
- Product
- smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.6Fr Introducer, REF 21-4165-24
- Where it went
- Worldwide distribution.
- How much
- 1695 units
Class I
smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9 Fr
Z-1278-2025 · Class I · reported 2025-03-26 · Ongoing
- Why it was recalled
- The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
- Product
- smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9 Fr Introducer, REF 21-4151-24
- Where it went
- Worldwide distribution.
- How much
- 643 units
CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100
Z-1404-2025 · Class II · reported 2025-03-26 · Ongoing
- Why it was recalled
- Airway adapter does not meet specification and may break off when attaching a valve or tube. Device failure may result in inaccurate readings, a break in airway circuit, and loss of ventilation. A break in the airway circuit could result in inability to ventilate, hypoxia, cardiopulmonary collapse, or death.
- Product
- CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100
- Where it went
- US Nationwide distribution. International distribution pending.
- How much
- 175,994 US; 45,223 OUS
Class I
smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.87,,O.D. (8.4Fr) s 1.0mm I.D., REF 2
Z-1277-2025 · Class I · reported 2025-03-26 · Ongoing
- Why it was recalled
- The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
- Product
- smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.87,,O.D. (8.4Fr) s 1.0mm I.D., REF 21-4150-24
- Where it went
- Worldwide distribution.
- How much
- 3 units
Class I
smiths medical ProPort Low Profile Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm
Z-1288-2025 · Class I · reported 2025-03-26 · Ongoing
- Why it was recalled
- The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
- Product
- smiths medical ProPort Low Profile Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9Fr Introducer, REF 21-4187-24
- Where it went
- Worldwide distribution.
- How much
- 2236 units
CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214
Z-1405-2025 · Class II · reported 2025-03-26 · Ongoing
- Why it was recalled
- Airway adapter does not meet specification and may break off when attaching a valve or tube. Device failure may result in inaccurate readings, a break in airway circuit, and loss of ventilation. A break in the airway circuit could result in inability to ventilate, hypoxia, cardiopulmonary collapse, or death.
- Product
- CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214
- Where it went
- US Nationwide distribution. International distribution pending.
- How much
- 175,994 US; 45,223 OUS
Class I
smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. (5.8 Fr) x 1.0
Z-1279-2025 · Class I · reported 2025-03-26 · Ongoing
- Why it was recalled
- The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
- Product
- smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. (5.8 Fr) x 1.0mm I.D., REF 21-4152-24
- Where it went
- Worldwide distribution.
- How much
- 2311 units
Class I
smiths medical ProPort Plastic Venous Access System, PolyFlow Catheter, 2.6 (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr I
Z-1283-2025 · Class I · reported 2025-03-26 · Ongoing
- Why it was recalled
- The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
- Product
- smiths medical ProPort Plastic Venous Access System, PolyFlow Catheter, 2.6 (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introducer, REF 21-4171-24
- Where it went
- Worldwide distribution.
- How much
- 1961 units
Class I
smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6m
Z-1281-2025 · Class I · reported 2025-03-26 · Ongoing
- Why it was recalled
- The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
- Product
- smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., REF 21-4155-24
- Where it went
- Worldwide distribution.
- How much
- 3263 units
Class I
smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0m
Z-1280-2025 · Class I · reported 2025-03-26 · Ongoing
- Why it was recalled
- The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
- Product
- smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm I.D., 6Fr Introducer, REF 21-4153-24
- Where it went
- Worldwide distribution.
- How much
- 9506 units
Class I
Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 1
Z-1289-2025 · Class I · reported 2025-03-19 · Ongoing
- Why it was recalled
- Affected devices have a smaller diameter than expected and may potentially result in inadequate ventilation to the patient. Patient may experience hypoxia, underdose, or cardiopulmonary collapse.
- Product
- Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035
- Where it went
- Worldwide - US Nationwide distribution.
smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-68 and REF 14-504-68JP
Z-0528-2025 · Class II · reported 2024-12-04 · Ongoing
- Why it was recalled
- Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between the end cap and the tube. This could lead to staining of the device or allowing the fluid to remain in the device. In addition, the Hypochlorite Solution (200ppm) and the 4% Acetic Acid disinfectants recommended in the IFU may be inadequate according to the disinfection standards for this type of device.
- Product
- smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-68 and REF 14-504-68JP
- Where it went
- Worldwide distribution.
- How much
- 10,223 units
smiths medical PORTEX Tracheal Tube Exchange Guide, 10Ch x 70cm, REF 14-504-76
Z-0529-2025 · Class II · reported 2024-12-04 · Ongoing
- Why it was recalled
- Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between the end cap and the tube. This could lead to staining of the device or allowing the fluid to remain in the device. In addition, the Hypochlorite Solution (200ppm) and the 4% Acetic Acid disinfectants recommended in the IFU may be inadequate according to the disinfection standards for this type of device.
- Product
- smiths medical PORTEX Tracheal Tube Exchange Guide, 10Ch x 70cm, REF 14-504-76
- Where it went
- Worldwide distribution.
- How much
- 12282 units
smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP
Z-0527-2025 · Class II · reported 2024-12-04 · Ongoing
- Why it was recalled
- Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between the end cap and the tube. This could lead to staining of the device or allowing the fluid to remain in the device. In addition, the Hypochlorite Solution (200ppm) and the 4% Acetic Acid disinfectants recommended in the IFU may be inadequate according to the disinfection standards for this type of device.
- Product
- smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP
- Where it went
- Worldwide distribution.
- How much
- 142327 units
smiths medical CADD-Solis Li-ion Rechargeable Battery Packs AC adapter, Model Number REF 21-0270-25, for use w
Z-0466-2025 · Class II · reported 2024-11-27 · Ongoing
- Why it was recalled
- The adapter input plug can become damaged or broken. If the input plug is damaged, the metal contacts to the body of the AC adapter may be exposed or one or more of the AC mains prongs may separate from the input plug.
- Product
- smiths medical CADD-Solis Li-ion Rechargeable Battery Packs AC adapter, Model Number REF 21-0270-25, for use with the CADD-Solis infusion pumps
- Where it went
- Worldwide distribution.
- How much
- 156,400 AC adapters
Class I
CADD-Solis Li-ion Rechargeable Battery Packs, REF 21-2160-XX, which are also sold as a component of the follow
Z-0222-2025 · Class I · reported 2024-11-06 · Ongoing
- Why it was recalled
- Damage to the battery pack may have caused a short to a capacitor within the battery pack. While the battery encasement is designed to be flame retardant, a short to the capacitor could lead to melting of the battery pack case. If this issue occurs, the battery pack charging circuit may become inoperable.
- Product
- CADD-Solis Li-ion Rechargeable Battery Packs, REF 21-2160-XX, which are also sold as a component of the following CADD Solis Ambulatory Infusion Systems: 21-2101-0100-50, 21-2101-0200-02, 21-2101-0200-03, 21-2101-0200-06, 21-2101-0200-07, 21-2101-0200-12, 21-2101-0200-14, 21-2101-0200-17, 21-2101-0200-238, 21-2101-249, 21-2101-51, 21-2102-0200-02, 21-2102-249, 21-2102-51, 21-2111-0100-00, 21-2111-0100-50, 21-2111-0100-51, 21-2111-0200-02, 21-2111-0200-03, 21-2111-0200-06, 21-2111-0200-07, 21-2111-0200-08, 21-2111-0200-12, 21-2111-0200-14, 21-2111-0200-17, 21-2111-0200-232, 21-2111-0200-50, 21-2111-0300-00, 21-2111-0300-01, 21-2111-0300-02, 21-2111-0300-03, 21-2111-0300-06, 21-2111-0300-07, 21-2111-0300-08, 21-2111-0300-09, 21-2111-0300-12, 21-2111-0300-14, 21-2111-0300-17, 21-2111-0300-231, 21-2111-0300-232, 21-2111-0300-50, 21-2111-0400-01, 21-2111-0400-51, 21-2111-0401-02L, 21-2111-0401-03L, 21-2111-0401-06L, 21-2111-0401-07, 21-2111-0401-07L, 21-2111-0401-08L, 21-2111-0401-12L, 21-2111-0401-14L, 21-2111-0401-17L, 21-2111-0401-249, 21-2111-0401-51, 21-2111-0401-51L, 21-2111-0401-78, 21-2111-0402-02, 21-2111-0402-02L, 21-2111-0402-03L, 21-2111-0402-06L, 21-2111-0402-07L,...
- Where it went
- Worldwide Distribution
- How much
- 138039 units
medex Arterial Kit 1/EA, Product Code REF MX7827
Z-0187-2025 · Class II · reported 2024-10-30 · Ongoing
- Why it was recalled
- Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
- Product
- medex Arterial Kit 1/EA, Product Code REF MX7827
- Where it went
- Worldwide distribution.
- How much
- 2232 units
smiths medical SurgiVet Advisor Tech Accessories, Product Code REF V2714
Z-0205-2025 · Class II · reported 2024-10-30 · Ongoing
- Why it was recalled
- Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
- Product
- smiths medical SurgiVet Advisor Tech Accessories, Product Code REF V2714
- Where it went
- Worldwide distribution.
- How much
- N/A
medex TranStar DPT w/Stopcock & 3cc Flush 10/EA, Product Code REF MX950SCFT
Z-0193-2025 · Class II · reported 2024-10-30 · Ongoing
- Why it was recalled
- Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
- Product
- medex TranStar DPT w/Stopcock & 3cc Flush 10/EA, Product Code REF MX950SCFT
- Where it went
- Worldwide distribution.
- How much
- 10 units
CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24JP
Z-0015-2025 · Class II · reported 2024-10-30 · Ongoing
- Why it was recalled
- Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.
- Product
- CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24JP
- Where it went
- Worldwide distribution.
- How much
- 109563 units
smiths medical portex, 'ORATOR' SPEAKING VALVE FOR TRACHEOSTOMY TUBE, REF 100/550/000
Z-0146-2025 · Class II · reported 2024-10-30 · Ongoing
- Why it was recalled
- Uncertainty in the seal integrity of the sterile packaging.
- Product
- smiths medical portex, 'ORATOR' SPEAKING VALVE FOR TRACHEOSTOMY TUBE, REF 100/550/000
- Where it went
- Worldwide distribution.
- How much
- 27,971 units
Showing the 30 most recent of 293. The rest are searchable at the FDA enforcement report database.
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
← All device recalls