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

16026–16050 of 39988

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
HighFDA (Devices)·Z-0157-2021·2020-10-28
Smith & Nephew Recalls TWINFIX ULTRA Absorbable Suture Anchors Due to Seal Defects
Smith & Nephew is recalling TWINFIX ULTRA absorbable suture anchors because improper or incomplete packaging seals may breach the sterile barrier.
Product
TWINFIX ULTRA 6.5MM PLLA/HA 2 UBWHT/BL-Absorbable Suture anchor Product Number: 72202608
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0256-2021·2020-10-28
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
149 IN (378cm) APPX 19.1 ml, 15 DROP SET, 3 Clave, REMV 3 GANG 4-WAY Clave STOPCOCK 2 EXT. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709074696(17)250101(30)25(10)4711277;(01)10887709074696(17)250201(30)25(10)4719610. . The Intravascular Administration Set is a…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0269-2021·2020-10-28
ICU Medical Recalls NanoClave Administration Sets Due to Manufacturing Defect
ICU Medical is recalling specific lots of NanoClave administration sets because a manufacturing defect may prevent a proper seal.
Product
20 cm (8 IN) APPX 1.0ml, PUR EXT SET, 3-PORT, NanoClave MANIFOLD, BCV, NanoClave.1 unit per pouch, 50 pouches per case. UDI:(01)10840619092754(17)250101(30)50(10)4584874; (01)10840619092754(17)250101(30)50(10)4565685 Administration sets and their accessories are single use…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0220-2021·2020-10-28
ICU Medical NanoClave Stopcock Manifold Recalled for Manufacturing Defect
ICU Medical is recalling specific lots of NanoClave Stopcock Manifolds due to a potential manufacturing defect on the internal surface that may inhibit a proper seal with the NanoClave spike.
Product
Appx 0.82 ml, 3 Gang 4-Way NanoClave¿ Stopcock Manifold w/Rotating Luer. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709053189(17)241201(30)50(10)4537253;(01)10887709053189(17)250101(30)50(10)4557545. The ICU Medical Clave Stopcock is a device used to…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0244-2021·2020-10-28
ICU Medical Recalls 128-inch Primary Sets Due to Seal Defect
ICU Medical is recalling specific lots of 128-inch primary sets because a manufacturing defect may prevent the NanoClave spike from sealing properly.
Product
128" (325 cm) Appx 16.6 ml, 15 Drop Primary Set w/2 MicroClave, Remv 2 Gang 4-Way Clave Stopcock, Rotating Luer, 2 Ext. 1 unit per pouch, 50 multivac pouches per case.UDI:(01)10887709011691(17)250201(30)50(10)4711125;(01)10887709011691(17)250201(30)50(10)4718711. The…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0233-2021·2020-10-28
ICU Medical Recalls 139-inch Admin Sets Due to Potential Seal Defect
ICU Medical is recalling specific lots of 139-inch intravascular administration sets because a manufacturing defect may prevent the NanoClave spike from sealing properly.
Product
139" (353 cm) 15 Drop Admin Set w/3 MicroClave Clear, 4-Way Stopcock, 3-Port NanoClave Manifold w/Check Valve, Spin Luer, 2 Ext. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709121147(17)250101(30)25(10)4556713; (01)10887709121147(17)250101(30)25(10)4603383…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0149-2021·2020-10-28
Smith & Nephew Recalls OSTEORAPTOR Suture Anchors Due to Seal Defects
Smith & Nephew is recalling OSTEORAPTOR 2.3 suture anchors because improper or incomplete packaging seals may breach the sterile barrier.
Product
OSTEORAPTOR 2.3 W/ 1 UB COBRAID BLACK-Absorbable Suture anchor Product Number: 72201992
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0168-2021·2020-10-28
Smith & Nephew Recalls Absorbable Suture Anchors Due to Seal Defects
Smith & Nephew is recalling HEALICOIL RSB SA absorbable suture anchors because improper packaging seals may breach the sterile barrier.
Product
HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL-- Absorbable Suture anchor Product Number: 72203704
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0225-2021·2020-10-28
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.
Product
112 IN (284cm) APPX 14.7ml 15 DROP SET 2 MicroClave, Remv 3-Port NanoClave Manifold, BCV.1 unit per pouch, 25 pouches per case. UDI:(01)10887709088501(17)250201(30)25(10)4733705. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0163-2021·2020-10-28
Smith & Nephew Recalls TWINFIX ULTRA HA Absorbable Suture Anchors
Smith & Nephew is recalling TWINFIX ULTRA HA absorbable suture anchors due to improper or incomplete packaging seals that may breach the sterile barrier.
Product
TWINFIX ULTRA HA 5.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product Number: 72202626
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0116-2021·2020-10-28
Ethicon Recalls VICRYL Sutures Due to Packaging Mismatch
Ethicon is recalling VICRYL sutures because the foil package may not match the label and carton. The incorrect suture differs in size, length, and construction.
Product
VICRYL MONOFILAMENT VIOLET 4IN (10CM) USP 10-0 (M0.2) SINGLE-ARMED CS140-6 - Product Usage: Intended for ophthalmic soft tissue approximation/ligation. Product Code: V960G
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0124-2021·2020-10-28
Quidel Recalls Sofia SARS Antigen FIA Package Inserts for Labeling Errors
Quidel Corporation is recalling package inserts for the Sofia SARS Antigen FIA test because instructions referencing specific viral transport media may lead to false-positive results.
Product
Sofia SARS Antigen FIA Package Insert The Sofia SARS Antigen FIA is a lateral flow immunofluorescent sandwich assay that is used with the Sofia and Sofia 2 instrument intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0159-2021·2020-10-28
Smith & Nephew Recalls TWINFIX ULTRA Absorbable Suture Anchors Due to Seal Defects
Smith & Nephew is recalling TWINFIX ULTRA absorbable suture anchors because improper or incomplete packaging seals may breach the sterile barrier.
Product
TWINFIX ULTRA PLLA HA 4.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202612
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0281-2021·2020-10-28
Sobel Westex Disposable Isolation Gowns Recalled for Performance Failures
Sobel Westex is recalling 3,380,850 disposable isolation gowns because they did not meet all performance test requirements. The gowns were distributed nationwide in the U.S.
Product
SOBEL WESTEX Disposable Isolation Gown Made in China RN#71273 SBPP non woven laminate with PE Film - Product Usage: use in patient/healthcare personnel interactions. AAMI Level II isolation gowns are intended for relatively low risk procedures, including blood draws, lab work…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0173-2021·2020-10-28
Smith & Nephew Recalls Healicoil Absorbable Suture Anchors for Seal Defects
Smith & Nephew is recalling Healicoil absorbable suture anchors because improper or incomplete packaging seals may breach the sterile barrier.
Product
HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product Number: 72203801
Category
Medical Device
Distribution
Distributed nationwide

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16026–16050 of 39988