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Smiths Medical ASD Inc.

Smiths Medical ASD Inc. Recalls

All product recalls associated with Smiths Medical ASD Inc..

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Recall Summary

Total Recalls

257

Past Year

Class I (Serious)

Most Recent

Apr 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 121–140 of 257 recalls

Smiths Medical ASD Inc.: Portex Lumbar Puncture Tray. Anesthesia Conduction Kit. 4...

Cases of Portex Lumbar Puncture Tray Child, SKU #4826PL-20 had been mislabeled with invalid information. The product was correct, but the inner trays were labeled as 4824PL-20 instead of 4826PL-20.

FDAFeb 28, 2020Nationwide• Smiths Medical ASD Inc.

Smiths Medical ASD, Inc.: Portex ProVent Arterial Blood Sampling Kit with Dry Lithi...

Lots of Smiths Medical Portex Pro-Vent and LineDraw Arterial Blood Sampling syringes may have broken luers.

FDAJan 7, 2020AL, AZ, AR +31 more• Smiths Medical ASD, Inc.

Smiths Medical ASD, Inc.: Portex LineDraw Arterial Blood Sampling Syringe with Dry ...

Portex Pro-Vent and LineDraw Arterial Blood Sampling syringes may have broken luers.

FDAJan 7, 2020

1...5 678 9...13

Page 7 of 13Next

AL, AZ, AR +31 more

• Smiths Medical ASD, Inc.

Smiths Medical ASD Inc.: Medfusion Syringe Pump, Model 4000. The Model 4000 pump ...

There is an anomaly in Medfusion 4000 Syringe Pump Firmware version 1.7.0 that could potentially result in loss of primary audible and visual battery alarm functionality, and interruption of therapy.

FDAOct 28, 2019CO, MD, NY• Smiths Medical ASD Inc.

Smiths Medical ASD Inc.: GRIPPER Needles sold individually. Labeled as the follow...

Potential for certain GRIPPER Needles to contain an occluded or blocked needle.

FDAJul 8, 2019Nationwide• Smiths Medical ASD Inc.

Smiths Medical ASD Inc.: GRIPPER Needles sold as part of PORT-A-CATH II SINGLE LUM...

Potential for certain GRIPPER Needles to contain an occluded or blocked needle.

FDAJul 8, 2019Nationwide• Smiths Medical ASD Inc.

Smiths Medical ASD, Inc.: Portex Anaerobic Pulsator Arterial Blood Sampling Kit, wi...

The outer box label is marked with the correct expiration date of 08/2016. The inner Tyvek Unit Label is marked with 08-2017 which exceeds the actual expiration date by one year.

Class IIILow

FDADec 17, 2014FL, IN• Smiths Medical ASD, Inc.

Smiths Medical ASD, Inc.: Hypodermic Needle Pro¿ Edge" Safety Device 20G x1; Reorde...

Needle is not captured in the needle safety sheath in specific lots.

Class IIModerate

FDANov 21, 2014Nationwide• Smiths Medical ASD, Inc.

Smiths Medical ASD, Inc.: Hypodermic Needle Pro¿ Edge" Safety Device with Syringe 2...

Needle is not captured in the needle safety sheath in specific lots.

Class IIModerate

FDANov 21, 2014Nationwide• Smiths Medical ASD, Inc.

Smiths Medical ASD, Inc.: Hypodermic Needle Pro¿ Edge" Safety Device with Syringe 2...

Needle is not captured in the needle safety sheath in specific lots.

Class IIModerate

FDANov 21, 2014Nationwide• Smiths Medical ASD, Inc.

Smiths Medical ASD, Inc.: CADD-Solis Medication Safety Software, Administrator CD, ...

Smiths Medical has identified an issue with a single batch (Lot Number 2752712) of CADD"-Solis Medication Safety Software Administrator 3.1 CDs. CADD"-Solis Medication Safety Software Administrator 3.1 CDs were sent with the CADD"-Solis Medication Safety Software Point of Care 3.1 software loaded on them.

Class IIModerate

FDASep 29, 2014Nationwide• Smiths Medical ASD, Inc.

Smiths Medical ASD, Inc.: CADD-LEGACY 1 Model 6400, Ambulatory Infusion Pump, REF...

The CADD-Legacy 1 Model 6400 Ambulatory Infusion Pump (Serial Number 370969) was shipped without documentation that the required accuracy testing had been performed during the manufacturing process. If the subject infusion pump did not go through the accuracy testing, and if it does not meet accuracy specifications, there is a potential for over or under-delivery.

FDADec 23, 2009MI• Smiths Medical ASD, Inc.

Smiths Medical ASD, Inc.: Smiths Medical Medfusion model 3010a syringe Infusion pum...

Smiths Medical has become aware of an increased trend in reports of Motor Not Running (MNR) and Motor Rate Error (MRE) alarm message events with certain Medfusion Syringe Infusion Pumps, Models 3010A and 3500 (Pump). MNR/ MRE are high priority alarm messages which can occur for a variety of reasons as part of the usual self-test functionality of the Pump. The Pump is designed so that when its so

FDANov 16, 2009AL, AK, AZ +44 more• Smiths Medical ASD, Inc.

Smiths Medical ASD, Inc.: Smiths Medical Medfusion model 3500 syringe Infusion pump...

FDANov 16, 2009AL, AK, AZ +44 more• Smiths Medical ASD, Inc.

Smiths Medical ASD, Inc.: Portex Continuous Epidural Tray, Reference 4037-20 An an...

Portex Continuous Epidural Tray was distributed with a 20G closed end, three eyed, nylon catheter without a stylet instead of the 20 G open end Teflon catheter with stylet specified on the label.

FDAJul 15, 2009Nationwide• Smiths Medical ASD, Inc.

Smiths Medical Asd Inc: Medex MX821L 72 inch (182.9cm) Administration Sets, Stand...

Misbranded/mispackaged device was distributed. Product labeled to contain 72 inch Standard Drip ( IV) Administration Sets, actually contained 60 inch (IV) administration sets with a' Y' site.

FDAMar 24, 2008IL, MN, NJ +2 more• Smiths Medical Asd Inc

Smiths Medical ASD, Inc.: Smiths Medical Oxy-PEEP High Flow O2 with PEEP; Positive ...

Incorrect Oxygen Level: Device may not provide expected oxygen concentration or the expected flow rate due to incorrectly molded part. Patient will not receive proper amounts of air/oxygen when in need.

FDAMar 4, 2008CA, FL, IN +8 more• Smiths Medical ASD, Inc.

Smiths Medical ASD, Inc.: Smiths Medical FLO2 Emergency Non-rebreather High Flow O2...

FDAMar 4, 2008CA, FL, IN +8 more• Smiths Medical ASD, Inc.

Smiths Medical Asd Inc: Smiths Medical, Add-On Kids Kit , Blood Sampling System,...

Misbranded; The product codes are labeled incorrectly with a green promotional label for "New split septum sampling site. Only use needle-free access devices .......", however this product code contains a sampling site which is accessed with a shrouded needle, NOT with a needle-free access device

FDANov 21, 2007Nationwide• Smiths Medical Asd Inc

Smiths Medical ASD, Inc.: Portex Perfit Percutaneous Tracheostomy Tube Replacement ...

Mislabeled. The product is labeled as a size 9.0 mm tracheostomy tube, but the package contains a 7.0 mm tracheostomy tube.

FDASep 18, 2007Nationwide• Smiths Medical ASD, Inc.