The Recall Desk

Manufacturer

Smiths Medical ASD, Inc.

293 recalls in our database name Smiths Medical ASD, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
293
Critical
9
Severe
71
Most recent
2025-05-14

Of the 293 recalls from Smiths Medical ASD, Inc. we have scored against our rubric, 9 (3%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 71 (24%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

151–175 of 293

  • HighFDA (Devices)·Z-0095-2022·2021-10-20

    Blood Sampling System Recalled for Pressure Shifts and Incorrect Readings

    Smiths Medical is recalling LogiCal Closed Blood Sampling System sets due to reported pressure shifts and incorrect pressure readings. Approximately 10,620 units were distributed in Austria, France, Germany, Great Britain, and Saudi Arabia.

    Product
    smiths medical medex CBSS 5 ml, Antishunt proximaler Entnahmeport 60 cm, Model Number DPSHC0081
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0094-2022·2021-10-20

    Smiths Medical blood sampling system recalled for pressure measurement errors

    Smiths Medical is recalling 3,100 units of its CBSS blood sampling system due to pressure measurement failures. The devices may show incorrect pressure readings or experience pressure shifts during use.

    Product
    smiths medical medex CBSS 2-fach Druckmesset mit Option, Model Number DPSHC0076
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0093-2022·2021-10-20

    Smiths Medical HemoDraw Plus Blood Sampling Sets Recalled for Pressure Monitoring Errors

    Smiths Medical ASD Inc. is recalling 140 HemoDraw Plus Closed Blood Sampling Sets with LogiCal Pressure Monitoring System for pressure shifts and incorrect pressure readings. Affected units were distributed to Austria, France, Germany, Great Britain, and Saudi Arabia.

    Product
    smiths medical medex HemoDraw Plus Closed Blood Sampling Set with LogiCal Pressure Monitoring System, Model Numbers: a) MX961H182P1 b) MX961H212P1 c) MX962H182P1 d) MX962H212P1
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0102-2022·2021-10-20

    Smiths Medical blood sampling system recalled for pressure reading errors

    Smiths Medical has recalled its Medex closed blood sampling system due to pressure shifts and incorrect pressure readings. Approximately 13,620 units were distributed internationally.

    Product
    smiths medical medex CBSS-5ML, Single Set, (172/15cm), Model Number DPSHC0093
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0096-2022·2021-10-20

    Smiths Medical LogiCal Blood Sampling Sets Recalled for Pressure Reading Errors

    Smiths Medical ASD Inc. is recalling 870 units of LogiCal blood sampling sets distributed across Europe and Saudi Arabia due to reported pressure shifts and incorrect pressure readings.

    Product
    smiths medical medex CBSS 5 ml, dreifach proximaler Entnahmeport 60 cm, Model number DPSHC0082
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0103-2022·2021-10-20

    Smiths Medical Blood Sampling System Recalled for Pressure Malfunction and Incorrect Readings

    Smiths Medical LogiCal MEDEX closed blood sampling system sets are recalled due to reported pressure shifts and incorrect pressure readings. Approximately 3,620 units were distributed to Austria, France, Germany, Great Britain, and Saudi Arabia.

    Product
    smiths medical medex CBSS-5ML, Double set, (172+15cm), Model Number DPSHC0094
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0097-2022·2021-10-20

    Smiths Medical CBSS blood sampling sets recalled for pressure measurement errors

    Smiths Medical is recalling CBSS 5 ml blood sampling sets (Model DPSHC0083) due to reported pressure shifts and incorrect pressure readings. Approximately 7,080 units were distributed in Austria, France, Germany, Great Britain, and Saudi Arabia.

    Product
    smiths medical medex CBSS 5 ml, einfach proximaler Entnahmeport 60 cm, Model Number DPSHC0083
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0092-2022·2021-10-20

    Medex LogiCal Closed Blood Sampling System Recalled for Pressure Reading Errors

    Smiths Medical ASD Inc. is recalling medex LogiCal 5mL Closed Blood Sampling System sets due to reported pressure shifts and incorrect pressure readings that could affect patient safety.

    Product
    medex LogiCal 5mL Closed Blood Sampling System, Model Numbers: a) MX961E181P1 b) MX961E211P1 c) MX962E211P1 d) MX96AE181P1 e) MX96AE211P1
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2376-2021·2021-09-15

    NORMOFLO Irrigation Fluid Warmer Recalled for Risk of Aluminum Leaching

    Smiths Medical recalls NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129 (913 units) due to potential harmful aluminum leaching when used at lower flow rates with certain solutions and blood products.

    Product
    NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2377-2021·2021-09-15

    NORMOFLO Irrigation Warming Sets Recalled for Aluminum Leaching Risk

    Smiths Medical is recalling NORMOFLO Irrigation Warming sets (Models IR-40, IR-500, IR-600, IRI-600, IRI-600B, IR-700) due to potential aluminum leaching when used at lower flow rates with certain solutions and blood products. No illnesses have been reported.

    Product
    NORMOFLO Irrigation Warming administration set (disposable), Models IR-40, IR-500, IR-600, IRI-600, IRI-600B, IR-700
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2401-2021·2021-09-08

    Smiths Medical Tracheal Intubation Stylet Recall Due to Incorrect Device

    Smiths Medical ASD Inc. is recalling 1,590 units of Smiths Medical Portex Tracheal Intubation Stylets because incorrect devices were found in packages. The affected lot was distributed internationally.

    Product
    smiths medical portex Tracheal Intubation Stylet, REF 100/120/200, 4.0mm OD X 335mm, 10/box, sterile.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1993-2021·2021-07-07

    Percutaneous Dilation Tracheostomy Kit Recalled for Incorrect Size Labeling

    One lot of PORTEX ULTRperc Percutaneous Dilation Tracheostomy Kit (Lot 4072715) was incorrectly labeled as 7.0mm when it is 9.0mm. The 40 units were distributed in Pennsylvania, Michigan, Maryland, and Florida.

    Product
    PORTEX UNLTRperc Percutaneous Dilation Tracheostomy Kit, REF 100/596/090 - Product Usage: intended for use in a controlled setting such as an Intensive Care Unit or operating room with the assistance of trained personnel.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1798-2021·2021-06-16

    Jelco Insulin Syringe Graduation Markings Recalled for Skew Defect

    Smiths Medical recalls 1,432,200 Jelco insulin syringes with skewed graduation markings that could lead to incorrect dosing. Specific lot numbers are affected.

    Product
    JELCO HYPODERMIC NEEDLE-PRO FIXED NEEDLE INSULIN SYRINGE: a) 1.0mL 28G X 1/2" (0.33mm x 13mm), REF 4428-1 b) 1.0mL 29G X 1/2" (0.33mm x 13mm), REF 4429-1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1515-2021·2021-05-05

    Smiths Medical Recalls Palm Cups Due to Incorrect Shipping Box Labels

    Smiths Medical ASD Inc. is recalling 682 Palm Cups because shipping box labels may be incorrect. The devices are intended to mobilize bronchial secretions.

    Product
    Palm Cups - Product Usage: intended to be used to percuss the chest wall to mobilize the secretions within the bronchial tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1516-2021·2021-05-05

    Smiths Medical Recalls ACE MDI Spacers Due to Labeling Errors

    Smiths Medical ASD Inc. is recalling 250 units of ACE MDI Spacers with Small Masks because shipping box labels may be incorrect.

    Product
    ACE MDI Spacer with Small Mask - Product Usage: designed to assist with the delivery of aerosolized medications from metered dose inhaler canisters and with mechanically ventilated patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1481-2021·2021-04-28

    Smiths Medical Recalls Medex Pressure Injector Lines Due to Weld Defects

    Smiths Medical ASD Inc. is recalling specific lots of Medex pressure injector lines and related components due to insufficient or incomplete welds.

    Product
    Medex 10 IN Pressure Injector Line w/Rot (1200psi) NS. REF B1681R, component of extravascular blood-pressure Transducer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1474-2021·2021-04-28

    Smiths Medical Recalls Medex High Pressure Adaptors and LogiCal Kits

    Smiths Medical ASD Inc. is recalling specific lots of Medex High Pressure Adaptors and LogiCal Kits due to insufficient or incomplete welds.

    Product
    Gang Cath Lab Set, Model Number M20858R1.for the administration of IV fluids. Stopcocks and manifolds are used to control the direction of IV fluid flow.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1476-2021·2021-04-28

    Smiths Medical Recalls Manifold Rotators Due to Incomplete Welds

    Smiths Medical ASD Inc. is recalling specific lots of manifold rotators and related components because they may have insufficient or incomplete welds.

    Product
    Manifold rotator (Component): a. 250 2 GANG MANIFOLD ROTATOR, OFF HANDLE, Model Number MX1232MR b. 250 3 GANG MANIFOLD ROTATOR, OFF HANDLE, Model Number MX1233MR c. 550 2 GANG MANIFOLD ROTATOR, OPEN HANDLE, Model Number MX1322MR d. 550 3 GANG MANIFOLD ROTATOR, OFF HANDLE, Mod
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1473-2021·2021-04-28

    Smiths Medical Recalls LogiCal Left Heart Kits Due to Weld Defects

    Smiths Medical ASD Inc. is recalling specific lots of LogiCal Left Heart Kits and related components due to insufficient or incomplete welds.

    Product
    LogiCal Left Heart Kit, Model Number M20553. for blood pressure monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1479-2021·2021-04-28

    Smiths Medical Recalls High Pressure Rotators Due to Incomplete Welds

    Smiths Medical ASD Inc. is recalling specific lots of Medex High Pressure Rotators because they may have insufficient or incomplete welds.

    Product
    HIGH PRESSURE ROTATOR (Component) a. WITH MALE LUER LOCK, Model Number MX496HP b. WITH FEMALE LUER LOCK, Model Number MX497HP. component of extravascular blood-pressure Transducer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1472-2021·2021-04-28

    Smiths Medical Recalls Left Heart Kits Due to Incomplete Welds

    Smiths Medical ASD Inc. is recalling specific lots of Left Heart Kits and related components due to insufficient or incomplete welds.

    Product
    Left Heart Kit, Model Number M20268. for blood pressure monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1471-2021·2021-04-28

    Smiths Medical Recalls Medex High Pressure Adaptors and LogiCal Kits

    Smiths Medical ASD Inc. is recalling specific lots of Medex High Pressure Adaptors and LogiCal Kits due to insufficient or incomplete welds.

    Product
    Mark 910 LogiCal, Model Number DPS567201. for blood pressure monitoring and blood sampling.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1480-2021·2021-04-28

    Smiths Medical Recalls Tubing Components Due to Incomplete Welds

    Smiths Medical ASD Inc. is recalling specific lots of tubing components for blood-pressure transducers due to insufficient or incomplete welds.

    Product
    Tubing with male luer lock adapter (Component) a. 76 cm, REF 601280 b. 122 cm, REF 607281. component of extravascular blood-pressure Transducer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1477-2021·2021-04-28

    Smiths Medical Recalls Stopcock Rotators Due to Incomplete Welds

    Smiths Medical ASD Inc. is recalling specific stopcock rotator components used in cardiac kits due to insufficient or incomplete welds.

    Product
    Stopcock rotator (Component): a. 1050 STOPCOCK ROTATOR, OFF HANDLE, Model Number MX1431MR b. 1050 STOPCOCK LEFT ROTATOR, OFF HANDLE, Model Number MX1431MRL c. 700 PSI STPCK W/ ROTATOR, Model Number MX4331R. Stopcocks and manifolds used to control the direction of IV fluid flo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1470-2021·2021-04-28

    Smiths Medical Recalls LogiCal Monitoring Sets Due to Incomplete Welds

    Smiths Medical ASD Inc. is recalling specific lots of LogiCal Monitoring Sets and related components due to insufficient or incomplete welds.

    Product
    LogiCal Monitoring Set, Model Number DPS564898. for blood pressure monitoring and blood sampling.
    Category
    Medical Device
    Distribution
    Distributed nationwide