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 deaths or serious injuries are reported, 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

901–925 of 27327

HighFDA (Devices)·Z-1781-2026·2026-04-15
Cook Medical tracheostomy introducer sets labeled with overstated expiration dates
Cook Medical is recalling Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Sets because affected lots were labeled with expiration dates that exceed the true shelf life. 484 units are affected.
Product
COOK MEDICAL Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-FLEX-HC, Order Number G32092; Reference Part Number C-PTIS-100-HC, Order Number G12115.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1783-2026·2026-04-15
Cook Medical Spectrum central venous catheter trays carry overstated expiration dates
Cook Medical is recalling custom Spectrum Central Venous Catheter Trays because affected lots were labeled with expiration dates that exceed the true shelf life. 1,872 units are affected.
Product
COOK MEDICAL Cook¿ Spectrum¿ Central Venous Catheter Tray: Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0003, Order Number G56424; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0018, Order Number G21053; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, Order Number G3
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1774-2026·2026-04-15
Molded Products Luer cap sets recalled after threaded sleeve detachment complaint
Molded Products is recalling the MPC-130 See Luer Cap Set following a confirmed complaint that the threaded sleeve was not engaged and became detached. 26,900 units are affected.
Product
See Luer Cap Set, MPC-130, set, administration, intravascular
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1784-2026·2026-04-15
Cook Medical bile duct exploration sets labeled with overstated expiration dates
Cook Medical is recalling the Strange Bile Duct Stone Exploration Set because affected lots were labeled with expiration dates that exceed the product's true shelf life. 49 units are affected.
Product
COOK MEDICAL Cook¿ Strange Bile Duct Stone Exploration Set: Reference Part Number C-CSRC-7.5D-40-STRANGE, Order Number G09108
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1786-2026·2026-04-15
Cook Medical multipurpose drainage catheters carry overstated expiration dates
Cook Medical is recalling a Multipurpose Drainage Catheter because affected lots were labeled with expiration dates that exceed the product's true shelf life. 20 units are affected.
Product
COOK MEDICAL Multipurpose Drainage Catheter: Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS, Order Number G29775
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1795-2026·2026-04-15
Preeclampsia growth factor assay recalled over out-of-range quality control values
B.R.A.H.M.S PlGF Plus KRYPTOR in vitro diagnostic tests are being recalled after customers observed out-of-range values at the lowest quality control level, which can contribute to falsely elevated results.
Product
B¿R¿A¿H¿M¿S KRYPTOR compact REACT, REF: 89986, used with B¿R¿A¿H¿M¿S PlGF Plus KRYPTOR, REF: 859075N, and run on the B¿R¿A¿H¿M¿S KRYPTOR compact PLUS analyzers. in vitro diagnostic test for Placental Growth Factor
Category
Medical Device
Distribution
15 states
HighFDA (Devices)·Z-1773-2026·2026-04-15
Xtant pedicle screws mislabeled with an incorrect shorter screw length
Xtant Medical is recalling Xpress Pedicle Screw System dual lead screws from one lot that were mislabeled with a part number identifying them as shorter than they physically are.
Product
XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1793-2026·2026-04-15
Multi-parameter command modules may produce inaccurate cardiac output readings
A circuit board issue in Multi-parameter Command Module model 91496 can start cardiac output measurement early in Auto mode, producing errors and inaccurate readings. 1,790 units are affected.
Product
Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1785-2026·2026-04-15
Cricothyrotomy catheter sets labeled with overstated expiration dates
Cook Incorporated is recalling Melker Universal Cuffed Emergency Cricothyrotomy Catheter Sets because affected lots were labeled with expiration dates that exceed the true shelf life.
Product
Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set: Reference Part Number C-TCCSB-500-UNI, Order Number G32193; Reference Part Number C-TCCSB-500-UNI-01, Order Number G47665.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1777-2026·2026-04-15
Cook Medical CTO-18 wire guides labeled with overstated expiration dates
Cook Medical is recalling Approach CTO-18 Micro Wire Guides because affected lots were labeled with expiration dates that exceed the product's true shelf life. 75 units are affected.
Product
COOK MEDICAL Approach CTO-18 Micro Wire Guide, Reference Part Number CMW-14-190-18G, Order Number G50788; Reference Part Number CMW-14-300-18G, Order Number G50792
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1792-2026·2026-04-15
Cook Medical pneumothorax tray labeled with an overstated expiration date
Cook Medical is recalling Wayne Pneumothorax Trays because affected lots were labeled with expiration dates that exceed the product's true shelf life. 318 units are affected.
Product
COOK MEDICAL Wayne Pneumothorax Tray: Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537; Reference Par
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1782-2026·2026-04-15
Cook Medical extubation set labeled with an overstated expiration date
Cook Medical is recalling Staged Extubation Sets because affected lots were labeled with expiration dates that exceed the product's true shelf life. 95 units are affected.
Product
COOK MEDICAL Cook Staged Extubation Set: Reference Part Number C-CAE-14.0-83-EXTU, Order Number G24073
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1648-2026·2026-04-08
Trilogy EV300 obstruction alarm may take up to four breaths
Philips Respironics is recalling the Trilogy EV300 ventilator because in some situations the Obstruction Alarm does not trigger within the timeframe required by the relevant standards.
Product
Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1647-2026·2026-04-08
Trilogy Evo O2 obstruction alarm may take up to four breaths
Philips Respironics is recalling the Trilogy Evo O2 ventilator because in some situations the Obstruction Alarm does not trigger within the timeframe required by the relevant standards.
Product
Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1589-2026·2026-04-08
Impella purge cassettes recalled as Class I over purge leak risk
Purge Cassettes sold within Impella Pump Sets and individually packaged are being recalled because of an increased risk of purge leaks with Generation 1 purge cassettes.
Product
Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in the below configurations and corresponding product codes. 1. Purge Cassette, 5 Pack; Product Code: 0043-0003. 2. Impella RP US Pump Set; Product Code: 004334. 3. Purge C
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1637-2026·2026-04-08
Volara ventilator adapter recalled as Class I over desaturation and barotrauma
Baxter is issuing an urgent correction for the Blue Ventilator Adapter Module used with the Volara system because home users may be unaware of possible oxygen desaturation or lung injury from overexpansion.
Product
Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxter Volara Respiratory Therapy system.
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-1646-2026·2026-04-08
Trilogy Evo obstruction alarm may take up to four breaths
Philips Respironics is recalling the Trilogy Evo ventilator because in some situations the Obstruction Alarm does not trigger within the timeframe required by the relevant standards.
Product
Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1649-2026·2026-04-08
Trilogy Evo Universal obstruction alarm may take up to four breaths
Philips Respironics is recalling the Trilogy Evo Universal ventilator because in some situations the Obstruction Alarm does not trigger within the timeframe required by the relevant standards.
Product
Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1591-2026·2026-04-08
Impella controller purge blocked alarm may be delayed on older pumps
Abiomed is recalling Automated Impella Controllers because the Purge System Blocked alarm display could be delayed when using first generation Impella 5.5 pumps.
Product
Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 3. Impella Controller, Packaged, UK; Produc
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1656-2026·2026-04-08
RefleXion X1 may deliver radiotherapy dose to the incorrect location
RefleXion Medical is recalling the X1 Radiotherapy System because a software defect can mean angular roll corrections are not carried through to treatment delivery.
Product
RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-1706-2026·2026-04-08
Medline bronchoscopy packs contain recalled Olympus biopsy valves shedding fragments
Medline is recalling three bronchoscopy convenience kits because they contain recalled Olympus biopsy valves, where rubber fragments may detach from the valve slit during use.
Product
Medline convenience kits containing Olympus biopsy valves: 1. BRONCH PACK, DYKE2096 2. NON MB BRONCHOPSCOPY CCH LH PK, DYNJT6182 3. PULMONARY BRONCH PACK, DYNDA2861A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1657-2026·2026-04-08
Atellica hemoglobin A1c assay may return depressed patient results
Siemens is recalling Atellica CH Enzymatic Hemoglobin A1c because results may be depressed when the RCRP reagent is processed on the same analyzer, with bias increasing over time.
Product
Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1738-2026·2026-04-08
Civco eTRAX 18G needle sensor may misreport needle tip position
Civco is recalling the eTRAX Needle Sensor 18G for Aurora trackers because an inspection and programming error may cause the needle tip position to be incorrectly identified.
Product
eTRAX Needle Sensor - 18G (for Aurora Trackers), Part Number 667-159
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-1743-2026·2026-04-08
MiniMed 640G insulin pump delivery varies with pump height changes
Medtronic is recalling MiniMed 640G insulin pumps because raising or lowering the pump relative to the infusion site can cause unintended over- or under-delivery of insulin.
Product
MiniMed 640G Insulin Pump (MMT-1711, MMT-1712, MMT-1751, MMT-1752)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1762-2026·2026-04-08
Burlington Medical half aprons may lose radiation attenuation over time
Burlington Medical is recalling half aprons because of the potential for attenuation degradation over time, decreasing the lifespan of the product.
Product
Burlington Medical, Half Aprons.
Category
Medical Device
Distribution
Distributed nationwide

How to read this listing

Filters

901–925 of 27327