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

12751–12775 of 27470

HighFDA (Devices)·Z-0259-2021·2020-10-28
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
5.5" (14 cm) Appx 0.39 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, NanoClave T-Connector, 3 Clamps, Rotating Luer.1 unit per pouch, 50 multivac pouches per case. UDI: (01)10887709032153(17)241101(30)50(10)4475297; (01)10887709032153(17)250201(30)50(10)4711598. The…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0153-2021·2020-10-28
Smith & Nephew Recalls OSTEORAPTOR Absorbable Suture Anchors Due to Seal Defects
Smith & Nephew is recalling OSTEORAPTOR absorbable suture anchors because improper or incomplete packaging seals may breach the sterile barrier.
Product
OSTEORAPTOR 2.9 W. 2 UB WHITE / BLACK -Absorbable Suture anchor Product Number: 72201996
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0267-2021·2020-10-28
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 NanoClave from sealing properly.
Product
135 cm (53") Ext Set w/Remv 5 Gang Stopcock, Baseplate w/7 NanoClave, 4-Way Stopcock, Rotating Luer, 1 Ext..1 unit per pouch, 25 pouches per case. UDI:(01)10840619060616(17)250201(30)25(10)4711366. Administration sets and their accessories are single use, pre-sterilized…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0276-2021·2020-10-28
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 from sealing properly.
Product
8" (20 cm) Appx 0.33 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave Clamp, Rotating Luer.1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709062946(17)250101(30)50(10)4603254; (01)10887709062946(17)250201(30)50(10)4630684…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0139-2021·2020-10-28
Smith & Nephew Recalls TWINFIX Absorbable Suture Anchors Due to Seal Issues
Smith & Nephew is recalling TWINFIX 6.5mm absorbable suture anchors because improper packaging seals may breach the sterile barrier.
Product
TWINFIX 6.5MM AB PRELOADED ULTRABRAID- Absorbable Suture anchors Product Number: 7210712
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0156-2021·2020-10-28
Smith & Nephew Recalls TWINFIX ULTRA Suture Anchors Due to Seal Defects
Smith & Nephew is recalling TWINFIX ULTRA PLLA/HA 5.5 W/3 UB Absorbable Suture Anchors because improper or incomplete packaging seals may breach the sterile barrier.
Product
TWINFIX ULTRA PLLA/HA 5.5 W/3 UB-Absorbable Suture anchor Product Number: 72202603
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0187-2021·2020-10-28
ICU Medical Recalls Smallbore Extension Sets Due to Manufacturing Defect
ICU Medical is recalling specific lots of 7-inch smallbore extension sets because a manufacturing defect on the NanoClave surface may inhibit a proper seal.
Product
7" (18cm) Appx 0.31 ml, Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave T-Connector, Clamp, Rotating Luer. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709051055(17)250101(30)50(10)4590834; (01)10887709051055(17)250101(30)50(10)4557481…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0231-2021·2020-10-28
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
10 IN (25cm) APPX 1.5ml, Ext w/3-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709080796(17)241201(30)50(10)4536743…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0201-2021·2020-10-28
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
7" (18 cm) Appx 0.32 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/Remv MicroClave Clear, NanoClave, Purple Clamp, Luer Lock; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709071527(17)250101(30)50(10)4603281. The high pressure extension set is a device…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0211-2021·2020-10-28
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
5.5" (14 cm) Appx 0.50 ml, Smallbore Trifuse Ext Set w/3 MicroClave" Clear, NanoClave" T-Connector, 3 Clamps, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case.UDI:(01)10887709097329(17)250201(30)50(10)4711084. The Intravascular Administration Set is a single…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0217-2021·2020-10-28
ICU Medical Recalls NanoClave Stopcock Sets Due to Seal Defect
ICU Medical is recalling specific lots of NanoClave stopcock sets due to a manufacturing defect that may prevent a proper seal.
Product
Appx 0.82 ml, 3 Gang 4-Way NanoClave Stopcock w/Baseplate, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709084435(17)250101(30)50(10)4549131. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0274-2021·2020-10-28
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 with the spike.
Product
58cm (23 IN) APPX 2.1 ml EXT SET Smallbore PUR Yellow w/6-Port Clave, Clave, 2 Clave Stopcock. 1 unit per pouch, 50 pouches per case. UDI: (01)10887709099859(17)241201(30)50(10)4536666. Administration sets and their accessories are single use, pre-sterilized devices that…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0254-2021·2020-10-28
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 stopcock from sealing properly.
Product
22" (56 cm) Appx 2.5 ml, Ext Set w/4-Way Clave Stopcock, Clamp, Luer Lock. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709051967(17)250101(30)50(10)4605591; (01)10887709051967(17)250201(30)50(10)4727498. The Intravascular Administration Set is a single use…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0185-2021·2020-10-28
ICU Medical Recalls NanoClave Extension Sets Due to Seal Defect
ICU Medical is recalling NanoClave extension sets because a manufacturing defect may prevent a proper seal with the spike.
Product
5 IN(13cm) APPX 0.87ml, EXT SET,NanoClave T-CONNECTOR; 1 unit per pouch, 50 pouches per case; UDI: (01)10887709052809(17)250101(30)50(10)4599980.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0174-2021·2020-10-28
Smith & Nephew Recalls Microraptor Regenesorb Suture Anchors for Seal Issues
Smith & Nephew is recalling Microraptor Regenesorb Suture Anchors because improper or incomplete pouch seals may breach the sterile barrier.
Product
MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Number: 72204983
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0278-2021·2020-10-28
ICU Medical Recalls Smallbore Extension Sets Due to Seal Defect
ICU Medical is recalling specific lots of 5.5-inch smallbore extension sets because a manufacturing defect may prevent the NanoClave spike from sealing properly.
Product
5.5" (14 cm) Appx 0.28 ml, Smallbore Ext Set w/NanoClave, Clamp, Luer Lock. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709077758(17)250101(30)50(10)4603285;(01)10887709077758(17)250101(30)50(10)4603285; (01)10887709077758(17)250101(30)50(10)4630700…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0194-2021·2020-10-28
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 from sealing properly.
Product
7" (18 cm) Appx 0.25 ml, Smallbore Ext Set w/Remv NanoClave, Clamp, Luer Lock. 1 unit per pouch, 50 multivac pouches per case. UDI: (01)10887709065069(17)250101(30)50(10)4590843;(01)10887709065069(17)250201(30)50(10)4733564. The Intravascular Administration Set is a single…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0263-2021·2020-10-28
ICU Medical Recalls NanoClave Connectors Due to Manufacturing Defect
ICU Medical is recalling specific lots of NanoClave Connectors due to a potential manufacturing defect on the internal surface that may inhibit a proper seal with the NanoClave spike.
Product
NanoClave Connector. 1 unit per pouch, 100 multivac pouches per case. UDI:(01)10840619060906(17)250101(30)100(10)4559476; (01)10840619060906(17)250201(30)100(10)4711354; (01)10840619060906(17)241101(30)100(10)4476111…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0251-2021·2020-10-28
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 a proper seal with the NanoClave spike.
Product
60 IN (152cm) APPX 1.1ml, TRIFUSE, Clave STOPCOCK, 2 Clave, FILTER. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709040103(17)250201(30)50(10)4726780. 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-0192-2021·2020-10-28
ICU Medical Recalls NanoClave Pressure Infusion Extension Sets Due to Seal Defect
ICU Medical is recalling specific lots of NanoClave pressure infusion extension sets because a manufacturing defect may prevent a proper seal.
Product
9.5" (24 cm) Appx 0.45 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/MicroClave, 2 NanoClave, NanoClave T-Connector, 3 Purple Clamps, Rotating Luer. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709049496(17)250101(30)50(10)4603265. The high pressure…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0239-2021·2020-10-28
ICU Medical Recalls APPX NanoClave Manifold Sets Due to Seal Defect
ICU Medical is recalling APPX 0.75 ml, 6-Port NanoClave Manifold sets because a manufacturing defect may prevent a proper seal with the spike.
Product
APPX 0.75 ml, 6-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709070551(17)241201(30)50(10)4542066; (01)10887709070551(17)241201(30)50(10)4549203; (01)10887709070551(17)250101(30)50(10)4558619…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0214-2021·2020-10-28
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 spike from sealing properly.
Product
99 IN (251cm) APPX 12.6ml, 20 Drop, 2 Clave, 2 NanoClave 4-Way Stopcocks, Drop-In Ext, Clave; 1 unit per pouch, 25 pouches per case. UDI: (01)10887709066318(17)241201(30)25(10)4515251; (01)10887709066318(17)241201(30)25(10)4537242. The Intravascular Administration Set is a…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0226-2021·2020-10-28
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 a proper seal, potentially affecting fluid administration.
Product
112 IN(284cm) APPX 14.6ml, 15 Drop Set 3 MicroClave, 3-Port NanoClave Manifold, BCV.1 unit per pouch, 25 pouches per case. UDI:(01)10887709088518(17)241101(30)25(10)4475764 (01)10887709088518(17)250201(30)25(10)4720644. The Intravascular Administration Set is a single use…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0252-2021·2020-10-28
ICU Medical Recalls NanoClave Sets Due to Potential Manufacturing Defect
ICU Medical is recalling specific lots of NanoClave sets because a manufacturing defect may prevent a proper seal, potentially affecting intravascular administration.
Product
120 IN (305cm)APPX 15.4ml, 10 DROP, 2 Clave STOPCOCK, NanoClave T-Connector, 2 CHECK VALVES. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709040141(17)250101(30)25(10)4573652. The SmartValve is a single use, sterile, non-pyrogenic pressure activated check valve…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0089-2021·2020-10-28
Medtronic Vascular Recalls Rashkind Balloon Septostomy Catheters Due to Field Failures
Medtronic Vascular is recalling 505 units of Rashkind Balloon Septostomy Catheters due to subsequent field failures and failed quality testing.
Product
Rashkind Balloon Septostomy Catheter, 4F, Closed end, 50 cm, Pediatric, Single Lumen Product number: 007161 GTIN: 00613994760272 The Rashkind balloon septostomy catheters are designed for creating an atrial septal defect or enlarging an existing atrial septal defect as a…
Category
Medical Device
Distribution
Distributed nationwide

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12751–12775 of 27470