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

16201–16225 of 40287

HighFDA (Devices)·Z-0237-2021·2020-10-28
ICU Medical Recalls NanoClave Intravascular Administration Sets Due to Seal Defect
ICU Medical is recalling specific lots of NanoClave intravascular administration sets because a manufacturing defect may prevent a proper seal with the spike.
Product
20 IN(51cm) APPX 2.5ml, Ext w/6-Port NanoClave Manifold, Check Valve.1 unit per pouch, 50 pouches per case. UDI:(01)10887709069203(17)250201(30)50(10)4742130; (01)10887709069203(17)250401(30)50(10)4803158; (01)10887709069203(17)250101(30)50(10)4558617…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0200-2021·2020-10-28
ICU Medical Recalls Intravascular Administration Sets Due to Manufacturing Defect
ICU Medical is recalling specific lots of intravascular administration sets because a manufacturing defect may prevent the NanoClave spike from sealing properly.
Product
12 IN(30cm) APPX 2.1ml, SMALLBORE HEXAFUSE SET, 6 MicroClave Clear, NanoClave 6 Check Valves;1 unit per pouch, 50 pouches per case. UDI: (01)10887709070100(17)250101(30)50(10)4572779; (01)10887709070100(17)250101(30)50(10)4548202. The Intravascular Administration Set is a…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0208-2021·2020-10-28
ICU Medical Recalls Smallbore Extension Sets Due to Seal Defect
ICU Medical is recalling specific lots of smallbore extension sets because a manufacturing defect may prevent the NanoClave spike from sealing properly.
Product
12" (30 cm) Appx 0.67 ml, Smallbore Ext Set w/NanoClave, 0.2 Micron Filter, Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709049496(17)250101(30)50(10)4603265; (01)10887709087526(17)250201(30)50(10)4724859…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0111-2021·2020-10-28
Vascular Solutions Recalls Langston Dual Lumen Catheters Due to Lumen Separation
Vascular Solutions, Inc. is recalling 89,121 Langston Dual Lumen Catheters because the inner lumen may separate from the hub during pressure injection.
Product
Langston Dual Lumen Catheter.
Category
Medical Device
Distribution
52 states
HighFDA (Devices)·Z-0232-2021·2020-10-28
ICU Medical Recalls NanoClave Intravascular Administration Sets Due to Seal Defect
ICU Medical is recalling specific lots of NanoClave intravascular administration sets because a manufacturing defect may prevent a proper seal with the spike.
Product
58 IN (147cm) APPX 8.0 ml, 3 Port NanoClave Manifold NanoClave Stopcock, MicroClave Clear.1 unit per pouch, 25 pouches per case. UDI:(01)10887709095298(17)250101(30)25(10)4573460; (01)10887709095298(17)250101(30)25(10)4589956; (01)10887709095298(17)250201(30)25(10)4711185.…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0271-2021·2020-10-28
ICU Medical Recalls DISTALE Bifuse Extension Sets Due to Seal Defect
ICU Medical is recalling specific lots of DISTALE Bifuse Extension Sets because a manufacturing defect may prevent a proper seal with the NanoClave spike.
Product
DISTALE - 203 cm (80") Bifuse Ext Set w/6 Gang 1o2 Manifold, 8 MicroClave Clear (Green Rings), Back Check Valve, 3-Port NanoClave Manifold, Check Valve, Rotating Luer, Filter Cap. 1 unit per pouch, 20 pouches per case. UDI:(01)10840619093201(17)241201(30)20(10)4537216…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0178-2021·2020-10-28
Bien-Air Surgery OSSEOSTAP Footcontrol Recalled for Magnet Defect
Bien-Air Surgery is recalling OSSEOSTAP foot pedals because an internal magnet may detach, causing the motor to start unattended and become unstoppable.
Product
Bien-Air Surgery REF 1600686-001 SN ******* OSSEOSTAP Footcontrol - Product Usage: an active medical device that convert electrical energy into mechanical rotation to a but during Ear, Nose and Throat (ENT) surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0262-2021·2020-10-28
ICU Medical Recalls CLAVE Neutron Connectors Due to Manufacturing Defect
ICU Medical is recalling specific lots of CLAVE Neutron intravascular catheter connectors due to a manufacturing defect that may inhibit a proper seal.
Product
8 IN (20CM) APPX 1.3ml, EXT SET w/3-Port NanoClave Manifold, Check Valve.1 unit per pouch, 50 pouches per case. UDI:(01)10887709085814(17)250101(30)50(10)4605676. CLAVE Neutron is a normally closed, bidirectional connector intended for use as an accessory to an…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0215-2021·2020-10-28
ICU Medical Recalls NanoClave Intravascular Administration Sets Due to Seal Defect
ICU Medical is recalling specific lots of NanoClave intravascular administration sets due to a manufacturing defect that may prevent a proper seal.
Product
29 IN (74 cm) APPX 3.9 ml, EXT SET w/ NanoClave 4-Way Stopcock; 1 unit per pouch, 50 pouches per case. UDI:(01)10840619082533(17)250101(30)50(10)4605138. ¿ The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0260-2021·2020-10-28
ICU Medical Recalls 124 Inch Burette Sets Due to Manufacturing Defect
ICU Medical is recalling specific lots of 124-inch burette sets because a manufacturing defect may prevent the NanoClave from sealing properly.
Product
124" (315 cm) 60 Drop 150 mL Burette Set (w/Clave, Shut-Off), Remv 2 Gang Clave Stopcocks, 2 Clave, Rotating Luer, 2 Ext. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709034959(17)250201(30)25(10)4719728. The Intravascular Administration Set is a single use, sterile…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0184-2021·2020-10-28
ICU Medical Recalls Smallbore Extension Sets Due to Seal Defect
ICU Medical is recalling specific lots of 6-inch smallbore extension sets because a manufacturing defect may prevent the NanoClave from sealing properly.
Product
6" (15 cm) Appx 0.24 ml, Smallbore Ext Set w/MicroClave Clear, Clamp, NanoClave T-Connector, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case; UDI: (01)10887709051031(17)250101(30)50(10)4605103;(01)10887709051031(17)250201(30)50(10)4733543 The Intravascular…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0243-2021·2020-10-28
ICU Medical Recalls NanoClave Intravascular Administration Sets Due to Seal Defect
ICU Medical is recalling specific lots of NanoClave intravascular administration sets because a manufacturing defect may prevent a proper seal with the spike.
Product
78" (198 cm) APPX 1.7ml, EXT SET, MicroClave Clear, 6-PORT NanoClave MANIFOLD, FILTER .1 unit per pouch, 50 pouches per case. UDI:(01)10887709121703(17)250201(30)50(10)4723226. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0134-2021·2020-10-28
Siemens Alkaline Phosphatase Reagent Cartridge Recall for Low Outlier Results
Siemens Healthcare Diagnostics is recalling Alkaline Phosphatase (ALPI) Flex reagent cartridges due to low outlier test results. The recall covers 5,970 US units and 1,446 international units.
Product
Siemens Dimension Vista Akaline Phosphatase (ALPI) Flex reagent cartridge - In vitro diagnostic test for the quantitative measurement of alkaline phosphatase in human serum and plasma Catalog Number: K2115, SMN# 10642444
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0196-2021·2020-10-28
ICU Medical Recalls Smallbore Trifuse Extension Sets Due to Seal Defect
ICU Medical is recalling specific lots of Smallbore Trifuse Extension Sets because a manufacturing defect may prevent the NanoClave spike from sealing properly.
Product
7.5" (19 cm) Appx 0.59 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear (Yellow, Green, Purple Rings), NanoClave T-Connector, 4 Clamps, Rotating Luer. UDI:(01)10887709067049(17)250101(30)50(10)4590847; (01)10887709067049(17)250101(30)50(10)4572752…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0137-2021·2020-10-28
Smith & Nephew Recalls TWINFIX Suture Anchors Due to Seal Issues
Smith & Nephew is recalling TWINFIX 5.0mm AB Suture Anchors because improper or incomplete packaging seals may breach the sterile barrier.
Product
TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO- Absorbable Suture anchors Product Number: 7210710
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0219-2021·2020-10-28
ICU Medical Recalls Intravascular Administration Sets Due to Potential Seal Defect
ICU Medical is recalling specific lots of intravascular administration sets because a manufacturing defect may prevent a proper seal with the NanoClave spike.
Product
113" (287 cm) Appx 14.7 ml, 10 Drop Admin Set w/MicroClave" Clear, Remv 4-Way NanoClave" Stopcock, Remv 2-Gang 4-Way NanoClave" Stopcocks, Spin Luer w/ Filter Cap, 2 Ext.1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709120171(17)250201(30)50(10)4734446. The…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0264-2021·2020-10-28
ICU Medical Recalls NanoClave Administration Sets Due to Seal Defect
ICU Medical is recalling specific lots of NanoClave administration sets due to a manufacturing defect that may prevent a proper seal.
Product
11 IN(28cm)APPX 0.7ml,SMALLBORE, 2 NanoClave, Filter. 1 unit per pouch, 50 pouches per case. UDI: ¿(01)10840619059801(17)250201(30)50(10)4718517; (01)10840619059801(17)241201(30)50(10)4514500; (01)10840619059801(17)250201(30)50(10)4727354. Administration sets and their…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0280-2021·2020-10-28
ICU Medical Recalls SURPLUG Nano Connectors Due to Manufacturing Defect
ICU Medical is recalling SURPLUG Nano Connectors because a manufacturing defect on the internal surface of the NanoClave may inhibit a proper seal with the spike.
Product
SURPLUG Nano Connector.1 unit per pouch, 100 multivac pouches per case. UDI:(01)54987892069913(17)221201(30)100(10)4476418. Administration sets and their accessories are single use, pre-sterilized devices that provide access for the administration of fluids from a container…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0205-2021·2020-10-28
ICU Medical Recalls Smallbore Intravascular Administration Sets Due to Seal Defect
ICU Medical is recalling specific lots of smallbore intravascular administration sets because a manufacturing defect may prevent the NanoClave spike from sealing properly.
Product
9.5" (24 cm) Appx 0.56 ml, Smallbore Ext Set w/NanoClave, 0.2 Micron Filter, Clamp, Luer Lock; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709080703(17)250101(30)50(10)4603290. The Intravascular Administration Set is a single use, sterile, non-pyrogenic…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0248-2021·2020-10-28
ICU Medical Recalls ChemoClave Sets Due to Potential Seal Defect
ICU Medical is recalling ChemoClave needle-free transfer sets because a manufacturing defect may prevent a proper seal, potentially allowing contaminants to enter the system.
Product
6.5 IN (17 cm) APPX 0.78 ml, Ext Set w/Clave Clear, Clave 4-Way Stopcock, Spiros Red Cap;1 unit per pouch, 50 pouches per case. UDI:(01)10887709098878(17)241201(30)50(10)4493149. The ChemoClave is a needle-free Closed System Transfer Device (CSTD) that mechanically…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0273-2021·2020-10-28
ICU Medical Recalls NanoClave Administration Sets Due to Seal Defect
ICU Medical is recalling specific lots of NanoClave administration sets because a manufacturing defect may prevent a proper seal.
Product
PROXIMALE, 28 cm (11 IN) APPX 1.0ml, EXT Set, 6-PORT NanoClave MANIFOLD, NanoClave. 1 unit per pouch, 50 pouches per case. UDI:(01)10840619093195(17)250101(30)50(10)4600271; (01)10840619093195(17)241201(30)50(10)4537220. Administration sets and their accessories are single…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0228-2021·2020-10-28
ICU Medical Recalls Intravascular Administration Sets Due to Manufacturing Defect
ICU Medical is recalling specific lots of intravascular administration sets because a manufacturing defect on the NanoClave component may prevent a proper seal.
Product
112 IN (284cm) APPX 14.8ml, 15 Drop Set 3 MicroClave, Remv 3-Port NanoClave Manifold, BCV.1 unit per pouch, 25 pouches per case. UDI:(01)10887709089904(17)250101(30)25(10)4713954. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0146-2021·2020-10-28
Smith & Nephew Recalls Bioraptor Suture Anchors Due to Packaging Seal Issues
Smith & Nephew is recalling Bioraptor 2.9mm Suture Anchors because improper or incomplete packaging seals may breach the sterile barrier.
Product
BIORAPTOR 2.9MM SUTURE ANCHOR-Absorbable Suture anchor Product Number: 72201702
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0195-2021·2020-10-28
ICU Medical Recalls NanoClave Intravascular Administration Sets Due to Seal Defect
ICU Medical is recalling specific lots of NanoClave intravascular administration sets because a manufacturing defect may prevent a proper seal.
Product
109" (277 cm) Appx 8.6 ml, Transfer Set w/Check Valve, NanoClave T-Connector, Anti-Siphon Valve, 4 Clamps, Smallbore Trifuse Ext Set w/2 MicroClave Clear, 0.2 Micron Filter, Rotating Luer. 1 unit per pouch, 50 multivac pouches per…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0268-2021·2020-10-28
ICU Medical Recalls Smallbore Quadfuse Extension Sets Due to Seal Defect
ICU Medical is recalling specific lots of Smallbore Quadfuse Extension Sets because a manufacturing defect may prevent the NanoClave spike from sealing properly.
Product
15 cm (6 IN) Appx 1.1 ml, Smallbore Quadfuse Ext Set w/4 NanoClave 3 BCV RLL.1 unit per pouch, 50 pouches per case. UDI:(01)10840619076174(17)250201(30)50(10)4735112; (01)10840619076174(17)241201(30)50(10)4493240. Administration sets and their accessories are single use…
Category
Medical Device
Distribution
Distributed nationwide

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16201–16225 of 40287