Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

35451–35475 of 40449

ModerateFDA (Devices)·Z-2031-2014·2014-07-16
Hospira Recalls GemStar Infusion Pumps Due to Beeper Connection Failure
Hospira is recalling 36,881 GemStar infusion pumps because the beeper subassembly connection may fail, rendering the device inoperable.
Product
GemStar infusion pump, List numbers 13000 and 13100, GemStar Infusion Pump (pain management) List number 13150. Used for intravenous, arterial, subcutaneous, short-term epidural infusion and parenteral administration of general I.V. fluids, medications, nutritional…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2012-2014·2014-07-16
Teleflex Medical Recalls Aquapak 640 SW Respiratory Gas Humidifier Adaptors
Teleflex Medical is recalling Aquapak 640 SW respiratory gas humidifier adaptors because creased packaging seals may affect integrity.
Product
Aquapak 640 SW, 650 mL w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1992-2014·2014-07-16
Amerigel Wound Dressing Recalled for Manufacturing Process Concerns
Kova Laboratories is recalling Amerigel Wound Dressing 1 oz. tubes because they may not have been manufactured pursuant to a validated process protocol and CGMP.
Product
Amerigel Wound Dressing 1 oz. tube
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-2016-2014·2014-07-16
Teleflex Medical Recalls Humidifier Adaptor 040 Due to Packaging Seal Issues
Teleflex Medical is recalling Humidifier Adaptor 040 units because creased packaging seals may affect integrity. The recall covers 7,758,650 units distributed worldwide.
Product
Humidifier Adaptor 040, Teleflex Medical, respiratory gas humidifier adaptor.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2003-2014·2014-07-16
Teleflex Medical Recalls Aquapak 340 SW Respiratory Gas Humidifier Adaptors
Teleflex Medical is recalling Aquapak 340 SW respiratory gas humidifier adaptors because creased packaging seals may affect integrity. The recall covers units distributed in the US and 12 other countries.
Product
Aquapak 340 SW, 340, mL w/040 Adaptor, International, Teleflex Medical, respiratory gas humidifier adaptor .
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2019-2014·2014-07-16
Terumo Advanced Perfusion System 1 Recall for Manual Clarity Issues
Terumo is recalling 1,713 Advanced Perfusion System 1 units because the operator manual lacks clarity and accuracy in specific instructions.
Product
Terumo¿ Advanced Perfusion System 1 220/240V AC, Advanced Perfusion System Platform (APS)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2024-2014·2014-07-16
Aesculap Recalls Non-Sterile Sutures With Conflicting Sterile Labeling
Aesculap is recalling 11 units of non-sterile Dafilon sutures because an additional label incorrectly states the product is sterile.
Product
Dafilon Suture Black 10/0 (0.2) 15 cm DRM4 NS, non-sterile, non-absorbable polyamide Surgical Suture, additional label affixed on the box states the product is sterile, packaged in a cassette holding 12 sutures
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-2011-2014·2014-07-16
Teleflex Aquapak SW/EAU Sterile Respiratory Gas Humidifier Adaptor Packaging Recall
Teleflex Medical is recalling Aquapak SW/EAU Sterile respiratory gas humidifier adaptors because creased packaging seals may affect integrity.
Product
Aquapak SW/EAU Sterile, 650 mL w/Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2037-2014·2014-07-16
Philips Gemini TF PET/CT Systems Recalled for E-Stop Malfunction
Philips is recalling 33 Gemini TF PET/CT systems because a software error can prevent the emergency stop from closing, rendering the equipment inoperable for clinical use.
Product
GEMINI TF PET/CT16: 882470, GEMINI TF PET/CT 64: 882471, GEMINI TF Big Bore: 882476. A diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2005-2014·2014-07-16
Teleflex Medical Recalls Aquapak 101 SW Respiratory Gas Humidifier Adaptors
Teleflex Medical is recalling Aquapak 101 SW respiratory gas humidifier adaptors because creased packaging seals may affect integrity.
Product
Aquapak 101 SW, 190, mL w/040 Adaptor, Japan, Teleflex Medical, respiratory gas humidifier adaptor
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2014-2014·2014-07-16
Teleflex Medical Recalls Aquapak 640 SW Respiratory Gas Humidifier Adaptors
Teleflex Medical is recalling Aquapak 640 SW respiratory gas humidifier adaptors because creased packaging seals may affect integrity. The recall covers units distributed in the US and 12 other countries.
Product
Aquapak 640 SW, 650 mL w/040 Adaptor, Japan, Teleflex Medical, respiratory gas humidifier adaptor.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1993-2014·2014-07-16
Kova Laboratories Recalls Amerigel Wound Dressing Due to Manufacturing Concerns
Kova Laboratories is recalling 3 drums of Amerigel Wound Dressing because the product may not have been manufactured according to validated protocols and CGMP.
Product
Amerigel Wound Dressing 55 gallons/drum
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-2017-2014·2014-07-16
Teleflex Medical Recalls Humidifier Adaptors Due to Packaging Seal Issues
Teleflex Medical is recalling 7.7 million Humidifier Adaptors because creased packaging seals may affect integrity. The products were distributed in the US and 12 other countries.
Product
Humidifier Adaptor, 040 Shelf Pak, French, Teleflex Medical, respiratory gas humidifier adaptor.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2009-2014·2014-07-16
Teleflex Medical Recalls Aquapak 340 SW Respiratory Gas Humidifier Adaptors
Teleflex Medical is recalling Aquapak 340 SW respiratory gas humidifier adaptors because creased packaging seals may affect integrity.
Product
Aquapak 340 SW, 340, mL w/040 Adaptor, Japan, Teleflex Medical, respiratory gas humidifier adaptor.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2007-2014·2014-07-16
Teleflex Medical Recalls Aquapak SW/EAU Respiratory Gas Humidifier Adaptors
Teleflex Medical is recalling Aquapak SW/EAU respiratory gas humidifier adaptors because creased packaging seals may affect integrity.
Product
Aquapak SW/EAU, Sterile, 340 mL, w/Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2013-2014·2014-07-16
Teleflex Medical Recalls Aquapak 640 SW Respiratory Gas Humidifier Adaptors
Teleflex Medical is recalling Aquapak 640 SW respiratory gas humidifier adaptors because creased packaging seals may affect integrity. The recall covers units distributed in the US and 11 other countries.
Product
Aquapak 640 SW, 650 mL w/040 Adaptor, French, Teleflex Medical, respiratory gas humidifier adaptor.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2036-2014·2014-07-16
Steris Recalls Reliance 1227 Washer Due to Door Handle Pin Deformation
Steris is recalling 37 Reliance 1227 Cart and Utensil Washer/Disinfector units because the door handle pin may deform or break, potentially rendering the door inoperable.
Product
Reliance 1227 Cart and Utensil Washer/Disinfector Product Usage: Usage: The Reliance 1227 Cart and Utensil Washer/Disinfector is intended for use in the cleaning and low-level disinfection of bedpans and urinals, basins, carts, beds, theater shoes and other miscellaneous…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2018-2014·2014-07-16
Terumo Advanced Perfusion System 1 Recall for Manual Clarity Issues
Terumo is recalling 1,713 Advanced Perfusion System 1 units because the operator manual lacks clarity and accuracy.
Product
Terumo¿ Advanced Perfusion System 1 100/120V AC, Advanced Perfusion System Platform (APS)
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2015-2014·2014-07-16
Teleflex Medical Recalls Respiratory Gas Humidifier Adaptors Due to Packaging Seal Issues
Teleflex Medical is recalling 7,758,650 respiratory gas humidifier adaptors because creased packaging seals may affect integrity. The recall covers units distributed in the US and 11 other countries.
Product
Adaptor, 040 Hum, International, Teleflex Medical, respiratory gas humidifier adaptor.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2004-2014·2014-07-16
Teleflex Medical Recalls Aquapak Respiratory Gas Humidifier Adaptors for Packaging Defects
Teleflex Medical is recalling Aquapak 640 SW and 650 mL respiratory gas humidifier adaptors because creased packaging seals may affect integrity.
Product
Aquapak 640 SW, 650, mL w/040 Adaptor, International, Teleflex Medical, respiratory gas humidifier adaptor .
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2006-2014·2014-07-16
Teleflex Medical Recalls Aquapak 340 SW Respiratory Gas Humidifier Adaptors
Teleflex Medical is recalling Aquapak 340 SW respiratory gas humidifier adaptors because creased packaging seals may affect integrity. The recall covers units distributed in the US and 12 other countries.
Product
Aquapak 340 SW, 340, mL w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1923-2014·2014-07-09
Medtronic Duet External Drainage System Tubing Disconnection Recall
Medtronic Neurosurgery is recalling Duet External Drainage and Monitoring Systems because the patient line tubing may become disconnected from the stopcock.
Product
Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, Catalog No. 46916. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of similar physical character from the ventricles or the lumbar…
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-1920-2014·2014-07-09
Medtronic Duet External Drainage System Tubing Disconnection Recall
Medtronic Neurosurgery is recalling Duet External Drainage and Monitoring Systems because the patient line tubing may disconnect from the stopcock.
Product
Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Catalog No. 46913. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of similar physical character from the ventricles or the lumbar subarachnoid…
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-1978-2014·2014-07-09
Stryker Triathlon Patella Inserter Recalled for Instrument Fracture Risk
Stryker Howmedica Osteonics is recalling 22 units of the Triathlon Tritanium Patella Inserter because the instrument may fracture during implantation.
Product
Stryker Orthopaedics Triathlon Tritanium Patella Inserter, . NON-STERILE Product Usage: The Triathlon Tritanium Patella Inserter is part of the Tritanium Knee System Instrument Set. It is used to implant the Tritanium Patella after the patellar bone has been prepared using…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1985-2014·2014-07-09
Siemens Mobilett XP X-ray System Recalled for Fire Hazard
Siemens is recalling 10 Mobilett XP Digital Mobile X-ray Systems due to a potential fire hazard from Lithium-Ion batteries installed between October 2010 and April 2011.
Product
Siemens Mobilett XP Digital Mobile X-ray System Product Usage: The Mobilett XP and Mobilett XP Hybrid are radiographic systems designed for use in wards, intensive care, and premature birth-wards, pediatric and emergency departments, operating theatres as well as the…
Category
Medical Device
Distribution
Distributed nationwide

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35451–35475 of 40449