Smiths Medical ASD Inc. recall records

138 reported ongoing

138 records in this archive. Latest source date Apr 10, 2025.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in cl...

The CADD Solis VIP Ambulatory Infusion Pump is indicated for the following uses: " For intravenous, intraarterial, subcutaneous, intraperitoneal, perineural, surgical site, epidural space, or subarachnoid space infusion.

Class IReported ongoing

Distribution: Worldwide

Official source for CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indica...
FDA device enforcement

smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS

When a paraPAC plus ventilator is switched to the operating mode of VENTILATE, the ventilator may intermittently provide continuous positive gas flow instead of the intended cycling like a human breath. This non-cycling and continuous positive gas flow when...

Class IReported ongoing

Distribution: Worldwide distribution: US (nationwide) and OUS countries of: Algeria, Armenia, Australia, Austria, Bangladesh, Bahrain, Bolivia, Plurinational state of, Brazil, Bulgaria, Canad...

Official source for smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS
FDA device enforcement

smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

When a paraPAC plus ventilator is switched to the operating mode of VENTILATE, the ventilator may intermittently provide continuous positive gas flow instead of the intended cycling like a human breath. This non-cycling and continuous positive gas flow when...

Class IReported ongoing

Distribution: Worldwide distribution: US (nationwide) and OUS countries of: Algeria, Armenia, Australia, Austria, Bangladesh, Bahrain, Bolivia, Plurinational state of, Brazil, Bulgaria, Canad...

Official source for smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA device enforcement

smiths medical Medfusion Model 4000 syringe pump

Medfusion Model 4000 syringe infusion pumps, with the following software versions, may have the following issues: 1. Delivery During Motor Not Running High Priority Alarm (v1.0.0, v1.1.0, v1.1.1, v1.1.2), 2. Re-administered Loading Dose (v1.0.0, v1.1.0, v1....

Class IReported ongoing

Distribution: US nationwide, Canada, Great Britain, Bermuda, Australia, Germany, Singapore, Saudi Arabia, Lebanon, and Malaysia

Official source for smiths medical Medfusion Model 4000 syringe pump
FDA device enforcement

Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500...

Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000716), Lot Numbers P0407365, P0486670, and P0561740 may contain a molding defect that could potentially lead to slippage of the spring within the ba...

Class IIReported ongoing

Distribution: Worldwide distribution.

Official source for Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-...
FDA device enforcement

Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0...

Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000716), Lot Numbers P0407365, P0486670, and P0561740 may contain a molding defect that could potentially lead to slippage of the spring within the ba...

Class IIReported ongoing

Distribution: Worldwide distribution.

Official source for Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50...
FDA device enforcement

Smiths Medical Model 3010 Syringe pumps: a. Protege Model 3010, b. Medfusion Model 3010A, c. Protege UK Model 3010E

Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000716), Lot Numbers P0407365, P0486670, and P0561740 may contain a molding defect that could potentially lead to slippage of the spring within the ba...

Class IIReported ongoing

Distribution: Worldwide distribution.

Official source for Smiths Medical Model 3010 Syringe pumps: a. Protege Model 3010, b. Medfusion Model 3010A, c. Prot...
FDA device enforcement

Smiths Medical Medfusion Guide Barrel Clamp, Item number G6000716

Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000716), Lot Numbers P0407365, P0486670, and P0561740 may contain a molding defect that could potentially lead to slippage of the spring within the ba...

Class IIReported ongoing

Distribution: Worldwide distribution.

Official source for Smiths Medical Medfusion Guide Barrel Clamp, Item number G6000716
FDA device enforcement

Medex LOGICAL CATH LAB KIT, List Number M20754

There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may poten...

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Canada, UAE.

Official source for Medex LOGICAL CATH LAB KIT, List Number M20754
FDA device enforcement

1050 STOPCOCK LEFT ROTATOR OFF HANDLE, List Number MX1431MRL

There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may poten...

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Canada, UAE.

Official source for 1050 STOPCOCK LEFT ROTATOR OFF HANDLE, List Number MX1431MRL
FDA device enforcement

6IN PRESSURE TUBING, List Number MX20617

There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may poten...

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Canada, UAE.

Official source for 6IN PRESSURE TUBING, List Number MX20617
FDA device enforcement

Medex 700PSI STOPCOCK W/ROTATOR, List Number MX4331R

There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may poten...

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Canada, UAE.

Official source for Medex 700PSI STOPCOCK W/ROTATOR, List Number MX4331R
FDA device enforcement

HIGH PRESSURE ROTATOR WITH MALE LUER LOCK, List Number MX496HP

There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may poten...

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Canada, UAE.

Official source for HIGH PRESSURE ROTATOR WITH MALE LUER LOCK, List Number MX496HP
FDA device enforcement

HIGH PRESSURE ROTATOR WITH FEMALE LUER LOCK, List Number MX497HP

There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may poten...

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Canada, UAE.

Official source for HIGH PRESSURE ROTATOR WITH FEMALE LUER LOCK, List Number MX497HP
FDA device enforcement

20IN (50.8CM) BRAIDED INJ LINE, ROTATING ADAPT, List Number MX682BR

There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may poten...

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Canada, UAE.

Official source for 20IN (50.8CM) BRAIDED INJ LINE, ROTATING ADAPT, List Number MX682BR
FDA device enforcement

Medex 20IN (50.8CM) INJ LINE ROTATING ADAPT, List Number MX682R

There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may poten...

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Canada, UAE.

Official source for Medex 20IN (50.8CM) INJ LINE ROTATING ADAPT, List Number MX682R
FDA device enforcement

48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi), List Number MX694R

There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may poten...

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Canada, UAE.

Official source for 48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi), List Number MX694R
FDA device enforcement

Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-1

The complaint involved the absence of a component called "ASM Filter-Pro ABG SYR CAP" from the packaging of Pro-Vent Arterial Blood Sampling (ABG) Kits. Specifically, this issue affected a total of 31,900 kits under the FGSKU# 4599P-1 and Lot# 4331283. Tube...

Class IIReported ongoing

Distribution: US

Official source for Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, ...
FDA device enforcement

Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile.

The unit box is labeled with an incorrect expiration date (the manufacturing date of 3/17/2021) but the individual packaging contains the correct expiration date (3/17/2026).

Class IIReported ongoing

Distribution: Distribution was made to AZ, CA, FL, HI, IL, IN, MA, MN, MO, MS, NC, NJ, OH, PA, SC, TX, VA, and WA. There was no government/military distribution. Foreign distribution was made...

Official source for Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile.

Reasons in these listed records

  • The CADD Solis VIP Ambulatory Infusion Pump is indicated for the following uses: " For intravenous, intraarterial, subcutaneous, intraperitoneal, perineural, surgical site, epidural space, or subarachnoid space infusion.
  • When a paraPAC plus ventilator is switched to the operating mode of VENTILATE, the ventilator may intermittently provide continuous positive gas flow instead of the intended cycling like a human breath. This non-cycling and continuous positive gas flow when in the cycling mode...
  • Medfusion syringe pumps, with software versions before v6.0.0, may have the following issues:1. Delivery During Motor Not Running High Priority Alarm, 2. Infusion Restarted with Incorrect Parameters, 3. Screen Lock, 4. Interruption of Bolus or Loading Dose Delivery, 5. Pump Di...
  • Medfusion Model 4000 syringe infusion pumps, with the following software versions, may have the following issues: 1. Delivery During Motor Not Running High Priority Alarm (v1.0.0, v1.1.0, v1.1.1, v1.1.2), 2. Re-administered Loading Dose (v1.0.0, v1.1.0, v1.1.1, v1.1.2), 3. Inc...

These examples come from this result page and are not a ranking of every recall reason.

Checking Smiths Medical ASD Inc.

Is there a recall on smiths medical asd inc. right now?

This archive contains 138 records, including 138 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

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Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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