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

23001–23025 of 40299

ModerateFDA (Devices)·Z-2653-2018·2018-08-15
ICU Medical Recalls Blood Sets With Inaccurate DEHP Labeling
ICU Medical is recalling specific lots of Y-Type Blood Sets because they are labeled as not containing DEHP, even though the product may contain small amounts of the chemical.
Product
98" (249 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Gang 4-Way Stopcocks, Clave¿, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2642-2018·2018-08-15
ICU Medical Recalls Blood Administration Sets Due to DEHP Labeling Error
ICU Medical is recalling 160,016 blood administration sets labeled as DEHP-free, though they may contain small amounts of DEHP.
Product
100" (254 cm) 20 Drop Y-Type Blood Admin Set w/200 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer w/Filter Cap, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2621-2018·2018-08-15
ICU Medical Recalls Blood Sets with Inaccurate DEHP Labeling
ICU Medical is recalling 160,016 Y-Type Blood Sets because some were labeled as not containing DEHP, though they may contain small amounts.
Product
140" (356 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 4-Way Stopcock, Clave¿, Rotating Luer, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2632-2018·2018-08-15
ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling
ICU Medical is recalling blood tubing accessories labeled as DEHP-free because they may contain small amounts of DEHP.
Product
100" (254 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer w/Filter Cap, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2650-2018·2018-08-15
ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling
ICU Medical is recalling specific lots of Y-Type Blood Sets because they were labeled as not containing DEHP, even though the product may contain small amounts of the chemical.
Product
115" (292 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Prepierced Ports¿, T-Connector w/Pre-Pierced Port, Luer Slip, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2643-2018·2018-08-15
ICU Medical Recalls Blood Sets With Inaccurate DEHP Labeling
ICU Medical is recalling specific blood tubing sets labeled as DEHP-free because they may contain small amounts of the chemical.
Product
99" (251 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2603-2018·2018-08-15
Medtronic CD HORIZON Spinal System Screws Recalled for Incorrect Laser Marking
Medtronic is recalling 47 CD HORIZON Spinal System screws because they are incorrectly laser marked as 5.5 mm diameter when they are actually 5.0 mm.
Product
Medtronic CD HORIZON Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, or sacral spine.MULTI-AXIAL SCREW FOR 5.5/6.0MM RODS, REF 55840005045
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2618-2018·2018-08-15
ICU Medical Recalls Blood Sets With Incorrect DEHP Labeling
ICU Medical is recalling 160,016 blood sets labeled as DEHP-free that may contain small amounts of DEHP.
Product
88" (224 cm) Y-Type Blood Set w/200 Micron Filter, Hand Pump, MicroClave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2740-2018·2018-08-15
Beaver Visitec Recalls Mislabeled Ophthalmic Slit Knives
Beaver Visitec is recalling 440 ophthalmic slit knives due to mislabeling on individual packages within correctly labeled cartons.
Product
Slit Knife 2.6mm 45degree Bevel Up, Model Number 373726. for use in ophthalmic surgery.
Category
Medical Device
Distribution
7 states
ModerateFDA (Devices)·Z-2622-2018·2018-08-15
ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling
ICU Medical is recalling 160,016 blood sets labeled as DEHP-free because they may contain small amounts of DEHP.
Product
84" Y-Type Blood Set w/170 Micron Filter, Hand Pump, Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2635-2018·2018-08-15
ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling
ICU Medical is recalling 105-inch Y-Type Blood Sets because some were labeled as not containing DEHP, even though the product may contain small amounts of the chemical.
Product
105" (267 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Pre-Slit Port, MicroClave¿ Clear, Rotating Luer, 1 Ext, Approx Priming Volume: 59.3 mL, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2644-2018·2018-08-15
ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling
ICU Medical is recalling specific blood tubing sets because they were labeled as not containing DEHP, even though they may contain small amounts of the chemical.
Product
99" (251 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2633-2018·2018-08-15
ICU Medical Recalls Bifuse Blood Sets Due to DEHP Labeling Error
ICU Medical is recalling 160,016 Bifuse Blood Sets because they are labeled as DEHP-free but may contain small amounts of DEHP.
Product
125" (318 cm) Bifuse Blood Set w/170 Micron Filter, Hand Pump, 4 MicroClave¿ Clear, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2647-2018·2018-08-15
ICU Medical Recalls Blood Tubing Accessories Due to Mislabeling
ICU Medical is recalling 160,016 units of Y-Type Admin Sets because they were labeled as not containing DEHP, though they may contain small amounts.
Product
134" (340 cm) Y-Type Admin Set w/170 Micron Blood Filter, Pump, Clave¿, 2 Gang 4-Way Stopcocks, Rotating Luer w/Filter Cap, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2649-2018·2018-08-15
ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling
ICU Medical is recalling 160,016 units of Y-Type Blood Sets because they were labeled as not containing DEHP, despite potentially containing small amounts.
Product
159" (404 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 4-Way Stopcock, 3 Pre-Pierced Ports, Luer Lock, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2620-2018·2018-08-15
ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling
ICU Medical is recalling 160,016 blood sets labeled as DEHP-free that may contain small amounts of DEHP. The devices were distributed in the US and several international countries.
Product
135" (343 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Remv 4-Way Stopcock, Rotating Luer, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2733-2018·2018-08-15
INOmeters for INOflo Cylinders Recalled Due to Incorrect Expiration Date Programming
INO therapeutics LLC is recalling 108 INOmeter devices affixed to INOflo cylinders in Japan because they were programmed with an incorrect expiration date.
Product
Mallinckrodt Pharmaceuticals INOflo DS, NO Gas Control System. Product Usage; Device Classification: The INOmeter is an accessory to the nitric oxide delivery device which is used for the delivery of inhaled nitric oxide to patient. An INOmeter is affixed to each…
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2658-2018·2018-08-15
ICU Medical Recalls Blood Tubing Accessories Due to DEHP Labeling Error
ICU Medical is recalling specific blood tubing accessories labeled as DEHP-free because they may contain small amounts of DEHP.
Product
120" (305 cm) 10 Drop Primary Set w/2 MicroClave¿, Hand Pump, Remv 2 Gang 4-Way Stopcock, Y-Connector, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2634-2018·2018-08-15
ICU Medical Recalls Blood Administration Sets with Incorrect DEHP Labeling
ICU Medical is recalling 160,016 blood administration sets labeled as DEHP-free because they may contain small amounts of DEHP.
Product
164" (417 cm) 20 Drop Y-Type Blood Admin Set w/200 Micron Filter, Hand Pump, Remv 4 Gang 4-Way Stopcocks w/Baseplate, 4 MicroClave¿ Clear, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2609-2018·2018-08-15
ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling
ICU Medical is recalling 160,016 blood sets labeled as DEHP-free because they may contain small amounts of DEHP.
Product
168 cm (66") 20 Drop Blood Set w/200 Micron Filter, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2655-2018·2018-08-15
ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling
ICU Medical is recalling specific lots of Y-Type Blood Sets because they were labeled as not containing DEHP, even though the product may contain small amounts of the chemical.
Product
107" (272 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Remv 2 Gang 4-Way Stopcocks, Rotating Luer, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2636-2018·2018-08-15
ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling
ICU Medical is recalling specific lots of Y-Type Blood Sets because they were labeled as not containing DEHP, even though the product may contain small amounts of the chemical.
Product
94" (239 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, MicroClave¿ Clear, Rotating Luer, Approx Priming Volume: 57.2 mL, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2626-2018·2018-08-15
ICU Medical Recalls Blood Sets With Incorrect DEHP Labeling
ICU Medical is recalling 160,016 blood tubing sets because they were labeled as not containing DEHP, though they may contain small amounts.
Product
99" (251 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2645-2018·2018-08-15
ICU Medical Recalls Blood Tubing Accessories Due to DEHP Labeling Error
ICU Medical is recalling specific blood tubing accessories because they were labeled as not containing DEHP, despite potentially containing small amounts.
Product
98" (249 cm) Y-Type Admin Set w/170 Micron Blood Filter, Pump, Clave¿, 2 Gang 4-Way Stopcocks, Luer Lock, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2624-2018·2018-08-15
ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling
ICU Medical is recalling 85-inch Y-Type Blood Sets because some units are labeled as not containing DEHP, even though the product may contain small amounts of the chemical.
Product
85" (216 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for…
Category
Medical Device
Distribution
Distributed nationwide

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23001–23025 of 40299