Stay Informed

Get email alerts when new recalls match your interests.

Recall data is updated hourly from official government sources. Very recent recalls may not yet appear. About our data sources

About

We make U.S. recall data searchable and accessible for consumers and businesses.

Site

FAQ
Browse by State
Statistics
Recall Classifications
About
Enterprise API

Legal

Privacy Policy
Terms of Service
Report Incorrect Info

Official Sources

FDA Recalls ↗
USDA FSIS ↗
CPSC Recalls ↗
NHTSA Recalls ↗

RSS Feed

Home
/
Brands
/
Smiths Medical PM, Inc.

Smiths Medical PM, Inc. Recalls

All product recalls associated with Smiths Medical PM, Inc..

Get alerts for this brand

Recall Summary

Total Recalls

559

Past Year

Class I (Serious)

Most Recent

Nov 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 441–460 of 559 recalls

Smiths Medical PM, Inc.: Advisor Vital Signs Monitor (model 9200), catalog number ...

Potential Safety related problem associated with the pace detect function on some Advisor monitors that have impedance respiration capabilities in that random pace markers may appear when the pace detect function is turned on and the primary lead is set to Lead II, III or any of the augmented leads, AVL, AVR or AVF on the Advisor monitor.

FDASep 1, 2005AZ, CA, KS +4 more• Smiths Medical PM, Inc.

Smiths Medical ASD, Inc.: Bivona brand TTS Adjustable Neck Flange Hyperflex Tracheo...

Instructions for use included in the package are for a different tracheostomy tube.

FDAJul 25, 2005Nationwide• Smiths Medical ASD, Inc.

Smith & Nephew, Inc., Endoscopy Div.: Smith & Nephew Drill, 2.7mm for BioRaptor Suture Anchor (...

Drill does not contain laser etched depth marks to assure proper depth of inserted device

1...21 222324 25...28

Page 23 of 28Next

FDA

Jul 1, 2005

NC, PR

• Smith & Nephew, Inc., Endoscopy Div.

Smiths Medical International Ltd Reachfields Boundry Road Hythe United Kingdom: Portex HEPA Bacterial /Viral Filter, Non-Latex Ref: 002890

Mislabeled: The package contains a Heat and Moisture (HME) filter instead of a HEPA filter stated on the product label

FDAJun 7, 2005CA, NJ, PA +1 more• Smiths Medical International Ltd Reachfields Boundry Road Hythe United Kingdom

Smiths Medical ASD, Inc.: Portex Per-Fit Percutaneous Dilational Tracheostomy Kit ,...

Guiding catheter may have thinner and weaker sidewalls than designed, and may break.

FDAMay 16, 2005Nationwide• Smiths Medical ASD, Inc.

Smiths Medical ASD, Inc.: Portex Hypodermic Needle-Pro Syringe & Needle 3mL/LL 25G ...

Mislabeled: Product may contain an incorrect needle size. Product labeled as a 25G x 1" may contain a 25G x 5/8"

FDAMay 5, 2005Nationwide• Smiths Medical ASD, Inc.

Smiths Medical ASD, Inc.: Bivona brand Pediatric TTS Tracheostomy Tube, 3.5 mm trac...

The obturator may be 3.0 mm in length instead of the labeled 3.5 mm.

FDAApr 26, 2005CT, GA, IL +5 more• Smiths Medical ASD, Inc.

Smiths Medical ASD, Inc.: Bivona brand Cuffless Extra Length Fixed Hyperflex Adult ...

The shaft was manufactured approximately 1 to 3 mm under the length specification, and may be 105 mm in length.

FDAApr 19, 2005CA, IN, NC• Smiths Medical ASD, Inc.

Smith & Nephew, Inc., Endoscopy Div.: Smith & Nephew Grasper, Cupped 3.4mm REF: 011014

Cupped Grasper Handle marked incorrectly as Duckbill Upbiter

FDAApr 6, 2005CA, MA, OH +1 more• Smith & Nephew, Inc., Endoscopy Div.

Smiths Medical PM, Inc.: Advisor Vital Signs Monitor (model 9200) with Capnography...

Altitude testing of the Advisor with Capnography module found the CO2 (End Tidal and Inspired) values are incorrect when the Advisor is configured to display in the relative units of percent (%) at elevations above 4,100 feet (at standard temperature pressure). The % CO values displayed will be lower than the actual CO2 value.

FDAMar 16, 2005CA, NY• Smiths Medical PM, Inc.

Smiths Medical ASD, Inc.: Bivona brand Neonatal TTS Tracheostomy Tubes, sterile, pr...

The word PED was printed on the neckflange instead of the word NEO.

FDAFeb 17, 2005GA, IL, IN +4 more• Smiths Medical ASD, Inc.

Smiths Medical PM, Inc.: Advisor Vital Signs Monitor model 9200, catalog number 92...

An issue with the pace detect function was discovered on a 9200 II monitor. Could result in a falsely high or low heart rate reading.

FDAJan 5, 2005Nationwide• Smiths Medical PM, Inc.

Smiths Medical ASD, Inc.: Equator Forced Air Convective Warming System, Reference N...

Warmer heater coil may come in contact with the filter housing, causing a small area of the plastic housing to melt

FDADec 15, 2004Nationwide• Smiths Medical ASD, Inc.

Smiths Medical MD, Inc.: Deltec branded Administration Sets for use with Deltec 30...

Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close completely and can allow fluid to leask past and may cause an inaccurate infusion rate..

FDADec 3, 2004Nationwide• Smiths Medical MD, Inc.

Smiths Medical MD, Inc.: Deltec branded PORT-A-CATH II Single-Lumen Low Profile Po...

The catheter became disconnected from the port while implanted in the patient.

FDANov 11, 2004FL, GA, IN +8 more• Smiths Medical MD, Inc.

Smiths Medical MD, Inc.: Deltec Cozmo 3 ml Insulin Cartridge with 0.7mm(22G) x 12...

Smiths Medical MD, Inc. (SMMD) has received several complaints relating to two lots of Cozmo Cartridges describing leakage of insulin into the cartridge chamber. Firm expanded recall 03/17/05 to include one more lot, based on in-house testing and review of customer complaints.

FDAOct 15, 2004Nationwide• Smiths Medical MD, Inc.

Smith & Nephew, Inc Endoscopy Division: Smith & Nephew TRIVEX System Pneumatic Footswitch, Part #...

Build-up of static charge in Pneumatic Footswitch tubing may cause control unit to reset to default settings in the operating room during surgery.

FDAOct 12, 2004Nationwide• Smith & Nephew, Inc Endoscopy Division

Smiths Medical MD, Inc.: Deltec Cozmo Insulin Pump

The vibratory alarm motor installed in a small number of Deltec Cozmo Insulin Pumps may function intermittently.

FDASep 18, 2004MD, OR• Smiths Medical MD, Inc.

Smiths Medical ASD, Inc.: Portex ULTRA-FLO 4 - Way Stopcock Catalog Number: T1209

Sterility of the device is compromised due to packaging defects

FDASep 9, 2004Nationwide• Smiths Medical ASD, Inc.

Smiths Medical ASD, Inc.: Portex Dual-Axis Swivel Adapter Catalog Number: 525151

Sterility of the device is compromised due to packaging defects

FDASep 9, 2004Nationwide• Smiths Medical ASD, Inc.