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.

251–275 of 293

HighFDA (Devices)·Z-1650-2014·2014-05-28
Smiths Medical Recalls Snuggle Warm Sterile Cardiac Warming Blankets
Smiths Medical ASD, Inc. is recalling 2,120 Snuggle Warm Sterile Cardiac Connective Warming Blankets because the hose could separate from the blanket.
Product
SW-2008 Snuggle Warm Sterile Cardiac Connective Warming Blanket; used with the Equator Convective Warmer, are intended for thermal regulation of a patient's temperture and are designed to prevent hypothermia and/ or reduce cold discomfort during and after surgical procedures.
Category
Medical Device
Distribution
9 states
HighFDA (Devices)·Z-1443-2014·2014-04-16
Smiths Medical HOTLINE Fluid Warming Set Recall for Injection Port Leaks
Smiths Medical is recalling HOTLINE Fluid Warming Sets because the injection port septum may leak or become dislodged, potentially causing blood or IV fluid leaks.
Product
Smiths Medical HOTLINE¿ Fluid Warming Set L-70. Product Usage: intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures under gravity conditions
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1444-2014·2014-04-16
Smiths Medical HOTLINE Fluid Warming Set Recall for Injection Port Leaks
Smiths Medical is recalling HOTLINE Fluid Warming Sets because the injection port septum may leak or become dislodged.
Product
Smiths Medical HOTLINE¿ Fluid Warming Set L-80. Product Usage: intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures under gravity conditions
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1182-2014·2014-03-19
Smiths Medical Recalls Arterial Blood Sampling Syringes Due to Plunger Tip Issue
Smiths Medical ASD, Inc. is recalling specific arterial blood sampling syringes due to a reported issue with the plunger tip. The devices are sterile, single-use in-vitro diagnostic tools used for drawing arterial blood.
Product
4043-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The
Category
Medical Device
Distribution
40 states
HighFDA (Devices)·Z-1187-2014·2014-03-19
Smiths Medical Recalls Arterial Blood Sampling Syringes Due to Plunger Tip Issue
Smiths Medical ASD, Inc. is recalling specific Arterial Blood Sampling Line Draw Syringes due to an issue with the plunger tip. The devices are sterile, single-use, and used for drawing arterial blood.
Product
4043E: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device (for sale in Europe only) Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood v
Category
Medical Device
Distribution
40 states
HighFDA (Devices)·Z-1185-2014·2014-03-19
Smiths Medical Recalls Arterial Blood Sampling Syringes Due to Plunger Tip Issue
Smiths Medical ASD, Inc. is recalling Portex Arterial Blood Sampling Line Draw Syringes due to an issue with the plunger tip.
Product
4042LH: 3 mL Line Draw, Luer lock syringe (heparin concentration: 7 I.U. per mL)with Filter-Pro¿ device Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The p
Category
Medical Device
Distribution
40 states
HighFDA (Devices)·Z-1186-2014·2014-03-19
Smiths Medical Recalls Arterial Blood Sampling Syringes Due to Plunger Tip Issue
Smiths Medical ASD, Inc. is recalling specific arterial blood sampling syringes due to an issue with the plunger tip. The devices are sterile, single-use diagnostic tools used for drawing arterial blood.
Product
4042E: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device (for sale in Europe only) Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood
Category
Medical Device
Distribution
40 states
HighFDA (Devices)·Z-1181-2014·2014-03-19
Smiths Medical Recalls Arterial Blood Sampling Syringes Due to Plunger Tip Issue
Smiths Medical ASD, Inc. is recalling specific arterial blood sampling syringes due to an issue with the plunger tip. The devices are used for in-vitro diagnostic blood sampling.
Product
4042-2: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The
Category
Medical Device
Distribution
40 states
HighFDA (Devices)·Z-1189-2014·2014-03-19
Smiths Medical Recalls Arterial Blood Sampling Syringes Due to Plunger Tip Issue
Smiths Medical ASD, Inc. is recalling Portex Arterial Blood Sampling Line Draw Syringes due to an issue with the plunger tip. The sterile, single-use devices are distributed worldwide.
Product
G1725: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device and 1 mL Line Draw Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device Arterial Blood Sampling Line Draw Syringes are sterile, single-use
Category
Medical Device
Distribution
40 states
HighFDA (Devices)·Z-1188-2014·2014-03-19
Smiths Medical Recalls Arterial Blood Sampling Syringes Due to Plunger Tip Issue
Smiths Medical ASD, Inc. is recalling specific arterial blood sampling syringes due to a reported issue with the plunger tip. The devices are sterile, single-use, in-vitro diagnostic tools used for drawing arterial blood.
Product
G1469J: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device (for sale in Japan only) Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood
Category
Medical Device
Distribution
40 states
ModerateFDA (Devices)·Z-1183-2014·2014-03-19
Smiths Medical Recalls Arterial Blood Sampling Syringes Due to Plunger Tip Issue
Smiths Medical ASD, Inc. is recalling Portex Arterial Blood Sampling Line Draw Syringes due to an issue with the plunger tip.
Product
4043G-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device and ice bag Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arter
Category
Medical Device
Distribution
40 states
ModerateFDA (Devices)·Z-1191-2014·2014-03-19
Smiths Medical Recalls Arterial Blood Sampling Syringes Due to Plunger Tip Issue
Smiths Medical ASD, Inc. is recalling Portex Arterial Blood Sampling Line Draw Syringes due to an issue with the plunger tip.
Product
G1777: Umbilical (2) 3 mL Line Draw, Luer lock syringes (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ devices and (2) Needle-Pro¿ Devices with 22G x 1¿needles Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices
Category
Medical Device
Distribution
40 states
ModerateFDA (Devices)·Z-1180-2014·2014-03-19
Smiths Medical Recalls Arterial Blood Sampling Syringes Due to Plunger Tip Issue
Smiths Medical ASD, Inc. is recalling specific lots of Portex Arterial Blood Sampling Line Draw Syringes due to an issue with the plunger tip.
Product
4040-2: Umbilical 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device, 22g x 1¿ needle, and Point-Lok¿ needle safety device Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices u
Category
Medical Device
Distribution
40 states
ModerateFDA (Devices)·Z-1192-2014·2014-03-19
Smiths Medical Recalls Arterial Blood Sampling Syringes Due to Plunger Tip Issue
Smiths Medical ASD, Inc. is recalling G2001 Arterial Blood Sampling Line Draw Syringes due to an issue with the plunger tip. The devices are sterile, single-use in-vitro diagnostic tools used for drawing arterial blood.
Product
G2001: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device, Needle-Pro¿ Device and 23G x 1 needle Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of art
Category
Medical Device
Distribution
40 states
ModerateFDA (Devices)·Z-1184-2014·2014-03-19
Smiths Medical Recalls Arterial Blood Sampling Line Draw Syringes
Smiths Medical ASD, Inc. is recalling Portex Arterial Blood Sampling Line Draw Syringes due to an issue with the plunger tip.
Product
4043W-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device, syringe tip cap and 6 mL Luer slip syringe Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawin
Category
Medical Device
Distribution
40 states
ModerateFDA (Devices)·Z-1190-2014·2014-03-19
Smiths Medical Recalls Arterial Blood Sampling Line Draw Syringes
Smiths Medical ASD, Inc. is recalling specific arterial blood sampling syringes due to a defect in the plunger tip.
Product
G1762: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device, syringe tip cap, and 5 mL Luer lock syringe Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing
Category
Medical Device
Distribution
40 states
HighFDA (Devices)·Z-0646-2014·2014-01-15
Smiths Medical Insulin Syringes Recalled for Visible Particulate on Needles
Smiths Medical is recalling 54,000 Hypodermic Needle-Pro insulin syringes due to visible orange or brown particulate on the needles.
Product
Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 0.5ml 29g x 1/2 in. Distributed by: Cardinal Health, Dublin, OH (Co-Brand) Reference: ED052905IN Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringes are sterile, latex free, non-pyrogenic, single us
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0645-2014·2014-01-15
Smiths Medical Insulin Syringes Recalled for Visible Particulate on Needles
Smiths Medical is recalling 108,000 Hypodermic Needle-Pro insulin syringes due to visible orange or brown particulate on the needles.
Product
Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 1.0ml 29g x 1/2 in Distributed by: Cardinal Health, Dublin, OH (Co-Brand) Reference: ED012905-IN Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringes are sterile, latex free, non-pyrogenic, single us
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0644-2014·2014-01-15
Smiths Medical Recalls Insulin Syringes With Visible Particulate on Needles
Smiths Medical is recalling 29-gauge insulin syringes due to visible orange or brown particulate on the needles. The recall covers 506,925 units distributed in the US, Canada, Italy, and Spain.
Product
Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 0.5ml 29g x 1/2 in Reference: 4429-5 Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringes are sterile, latex free, non-pyrogenic, single use devices intended for injection of U-100 insulin only. The sy
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0643-2014·2014-01-15
Smiths Medical Recalls Insulin Syringes With Visible Particulate on Needles
Smiths Medical ASD, Inc. is recalling 93,700 units of Hypodermic Needle-Pro Fixed Needle Insulin Syringes due to visible orange or brown particulate on the needles.
Product
Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 0.3ml 29g x 1/2 in Reference: 4429-3 Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringes are sterile, latex free, non-pyrogenic, single use devices intended for injection of U-100 insulin only. The sy
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0642-2014·2014-01-15
Smiths Medical Recalls Insulin Syringes Due to Visible Particulate on Needles
Smiths Medical is recalling specific lots of Hypodermic Needle-Pro Fixed Needle Insulin Syringes because visible orange or brown particulate was found on the needles.
Product
Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 1.0ml 29g x 1/2 in Reference: 4429-1 Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringes are sterile, latex free, non-pyrogenic, single use devices intended for injection of U-100 insulin only. The sy
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0540-2014·2013-12-25
Smiths Medical Recalls Medfusion 4000 Syringe Infusion Pumps for Electrical Shorting
Smiths Medical is recalling Medfusion 4000 Syringe Infusion Pumps because conductive fluids entering the AC power receptacle can cause electrical shorting, sparking, or flames.
Product
Medfusion¿ 4000 Syringe Infusion Pumps Medfusion¿ 4000 Syringe Infusion Pumps are designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates. These pumps are indicated for use by healthcare professionals in the delivery of IV
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0160-2014·2013-11-13
Smiths Medical Recalls Portex Spinal Trays with Visual Particulate in Ampules
Smiths Medical ASD, Inc. is recalling Portex Spinal Anaesthesia Trays because visual particulate was found in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection.
Product
Portex¿ Spinal Tray with Drugs 25g Whitacre; 15597-20 The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal, nerve block, lumbar pu
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0164-2014·2013-11-13
Smiths Medical Recalls Portex Spinal Trays with Particulate Contamination
Smiths Medical is recalling Portex Spinal Anaesthesia Trays because visual particulate was found in the included Lidocaine and Dextrose ampules.
Product
Portex¿ Saddleblock Tray with Drugs 25g Quincke; 4795-20 The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal, nerve block, lumb
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0158-2014·2013-11-13
Smiths Medical Recalls Portex Spinal Trays with Particulate Contamination
Smiths Medical ASD, Inc. is recalling Portex Spinal Trays because visual particulate was found in the included Lidocaine and Dextrose ampules.
Product
Portex¿ Spinal Tray with Drugs 25g Whitacre; 15545C-21 The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal, nerve block, lumbar p
Category
Medical Device
Distribution
Distributed nationwide