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

12826–12850 of 27470

HighFDA (Devices)·Z-0204-2021·2020-10-28
ICU Medical Recalls NanoClave High Pressure Extension Sets Due to Seal Defect
ICU Medical is recalling specific lots of NanoClave high pressure extension sets because a manufacturing defect may prevent a proper seal.
Product
6.5" (17 cm) Appx 0.35 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/Remv MicroClave Clear, NanoClave, Purple Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709080390(17)250101(30)50(10)4572792. The high pressure extension set is a…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0169-2021·2020-10-28
Smith & Nephew Recalls Healicoil Suture Anchors Due to Packaging Seal Issues
Smith & Nephew is recalling Healicoil absorbable suture anchors because improper or incomplete packaging seals may breach the sterile barrier.
Product
HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BK-- Absorbable Suture anchor Product Number: 72203705
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0229-2021·2020-10-28
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
78 IN (198cm) APPX 10.0 ml, 20 Drop Set 3-Port NanoClave Manifold, BCV, MicroClave. 1 unit per pouch, 24 pouches per case.UDI:(01)10887709090634(17)241201(30)25(10)4537328. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0266-2021·2020-10-28
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 the spike from sealing properly.
Product
8 IN(20cm) APPX 0.46ml, MicroClave CLEAR, NanoClave T-CONN, FILTER. 1 unit per pouch, 50 pouches per case. UDI: (01)10840619066052(17)250201(30)50(10)4717491. Administration sets and their accessories are single use, pre-sterilized devices that provide access for the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0275-2021·2020-10-28
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, potentially affecting fluid administration.
Product
226 cm (89 IN) APPX 2.7ml, MicroClave Clear, 1.2v FILTER Nanoclave T-CONN. 1 unit per pouch, 50 pouches per case. UDI: (01)10840619061231(17)250201(30)50(10)4734990. Administration sets and their accessories are single use, pre-sterilized devices that provide access for the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0147-2021·2020-10-28
Smith & Nephew Recalls Raptormite Suture Anchors Due to Seal Defects
Smith & Nephew is recalling Raptormite suture anchors because improper packaging seals may breach the sterile barrier.
Product
RAPTORMITE 3.7MM AB W/ NEEDLES AND TWO-Absorbable Suture anchor Product Number: 72201805
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0143-2021·2020-10-28
Smith & Nephew Recalls Ultra Fast-Fix Absorbable Suture Anchors
Smith & Nephew is recalling Ultra Fast-Fix AB Assembly suture anchors due to improper or incomplete packaging seals that may breach the sterile barrier.
Product
ULTRA FAST-FIX AB ASSEMBLY - STRAIGHT-Absorbable Suture anchors Product Number: 72201493
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0132-2021·2020-10-28
Maquet Yuno Mobile Operating Table Recalled for Electric Shock Risk
Maquet is recalling Yuno Mobile Operating Tables because a plastic socket may pull out, exposing electronic parts and creating an electric shock hazard.
Product
Yuno Mobile Operating Table - Product Usage: Intended for support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment. Part 143301F0 (US) Part 143301B0 (OUS)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0198-2021·2020-10-28
ICU Medical Recalls Intravascular Administration Sets Due to Seal Defect
ICU Medical is recalling specific lots of intravascular administration sets because a manufacturing defect may prevent the NanoClave from sealing properly.
Product
107" (272 cm) Appx 9.1 ml, Smallbore Ext Set w/2 Check Valves, NanoClave T-Connector, Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI: (01)10887709085005(17)250101(30)50(10)4572911. The Intravascular Administration Set is a single use, sterile…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0247-2021·2020-10-28
ICU Medical Recalls NanoClave Intravascular 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
7 IN (18CM) APPX 0.26ml, SMALLBORE EXT SET, MicroClave, Clave T-Connector.1 unit per pouch, 50 pouches per case. UDI: (01)10887709018065(17)250101(30)50(10)4572133. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0223-2021·2020-10-28
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, potentially affecting fluid administration.
Product
26 IN(66cm) APPX 3.9 ml, SET, 3-Port NanoClave Manifold, Check Valve, 2 MicroClave;1 unit per pouch, 50 pouches per case. UDI:(01)10887709086224(17)250201(30)50(10)4718658. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0238-2021·2020-10-28
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
11" (28 cm) Appx 1.7 ml, Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, NanoClave 4-Way Stopcock, Rotating Luer. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709069524(17)250201(30)50(10)4711196. The Intravascular Administration Set is a single use…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0212-2021·2020-10-28
ICU Medical NanoClave Stopcock Recalled for Potential Manufacturing Defect
ICU Medical is recalling NanoClave Stopcocks due to a potential manufacturing defect on the internal surface that may inhibit a proper seal with the NanoClave spike.
Product
NanoClave Stopcock w/NanoClave; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709062112(17)250101(30)50(10)4572842. The ICU Medical Clave Stopcock is a device used to administer or withdraw fluids that flow from a container to a patient's vascular system…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0253-2021·2020-10-28
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
60 IN(152cm) APPX 0.85ml, SMALLBORE, CLAVE STOPCOCK, MicroCLAVE CLEAR. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709040264(17)250201(30)50(10)4714442. 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-0158-2021·2020-10-28
Smith & Nephew Recalls TWINFIX ULTRA Absorbable Suture Anchors
Smith & Nephew is recalling TWINFIX ULTRA absorbable suture anchors due to improper or incomplete packaging seals that may breach the sterile barrier.
Product
TWINFIX ULTRA PLLA/HA 6.5 W/3 UB- Absorbable Suture anchor Product Number: 72202610
Category
Medical Device
Distribution
Distributed nationwide
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

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12826–12850 of 27470