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

1851–1875 of 27375

HighFDA (Devices)·Z-0368-2026·2025-11-05
Medication dispensing stations recalled over fluid ingress causing smoke or fire
CareFusion is recalling 2,755 BD Pyxis MedFlex units because potential fluid ingress of the anesthesia or med station may result in smoke, system downtime and/or fire.
Product
Various models of BD Pyxis MedFlex, Reference numbers: 1119-00 1139-00 139038-01 139039-01 139040-01 139041-01 139043-01 139044-01 139045-01 139046-01 139049-01 139051-01 139052-01 139053-01 139054-01 139055-01 139056-01 139058-01 139059-01 139060-01 139061-0
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0306-2026·2025-11-05
Surgical console accessories recalled over incomplete seals in sterile pouches
Alcon Research is recalling six accessory devices for Unity and Constellation surgical consoles because of incomplete seals in the pouch that provides the sterile barrier.
Product
Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000393 UNITY HP VISCOUS FLUID CONTROL VFC PACK Software Version: N/A Product Descr
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0415-2026·2025-11-05
Cardiac control material recalled over vial to vial troponin variability
Microgenics is recalling 4,462 units of Thermo Scientific MAS Omni CARDIO control after customers reported vial-to-vial variability with high sensitivity Troponin I assays.
Product
Thermo scientific MAS Omni CARDIO, Liquid Assayed Integrated Cardiac Control, Model/Catalog Number: OCRD-L, OCRD-101, OCRD-202, OCRD-303, OCRD-SP, OCRD-MP, OCRD-UL; Product Description: In Vitro Diagnostic external control
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0330-2026·2025-11-05
Non-sterile bulk ChemoLock ports recalled over port weld separation risk
ICU Medical is recalling 2,000 bulk non-sterile ChemoLock Ports because the port weld of the drug transfer device may separate or break during use and leak.
Product
ICU Medical ChemoLock" Port, Bulk, Non-Sterile REF: CL2100-NS
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0344-2026·2025-11-05
20mm vented vial spikes recalled over port weld separation risk
ICU Medical is recalling 11,200 ChemoLock Vented Vial Spikes, 20mm, because the port weld of the drug transfer device may separate or break during use and leak.
Product
ICU Medical ChemoLock Vented Vial Spike, 20mm REF: CL-70S
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0309-2026·2025-11-05
Trocar sealing units with reducer recalled over detaching silicone fragments
Aesculap is recalling 26 sealing units for 10/12mm trocars with reducer because silicone fragments may detach from the yellow sealing component.
Product
Brand Name: Aesculap Product Name: SEALING UNIT F/10/12MM TROCARS W.REDUCER Model/Catalog Number: EK083P Software Version: N/A Product Description: SEALING UNIT F/10/12MM TROCARS W.REDUCER Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0377-2026·2025-11-05
Brazil market CT scanner recalled over six software faults affecting movement
Philips Medical Systems is recalling one Incisive CT for Brazil SKD unit on software versions 5.1.0.X and 5.1.1.X over six software issues, including unintentional gantry and couch movement.
Product
Model: Incisive CT for Brazil SKD; Product Code (REF): 728146; Software Versions: 5.1.0.X & 5.1.1.X;
Category
Medical Device
Distribution
18 states
HighFDA (Devices)·Z-0307-2026·2025-11-05
Chandelier illuminators recalled over incomplete seals in the sterile pouch
Alcon Research is recalling 330 accessory devices for Unity and Constellation surgical consoles because of incomplete seals in the pouch that provides the sterile barrier.
Product
Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000252 UNITY 27 GA CHANDELIER 8065000253 UNITY 27+DS WIDE ANGLE LIGHT PROBE Softwa
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0340-2026·2025-11-05
73 inch smallbore extension sets recalled over port weld separation risk
ICU Medical is recalling 200 73-inch smallbore extension sets with ChemoLock port because the port weld of the drug transfer device may separate or break during use and leak.
Product
ICU Medical 73" (185 cm) Appx 2.5 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, ChemoLock w/Red Cap REF: CL4176
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0366-2026·2025-11-05
Parathyroid hormone assay recalled over falsely depressed results at low range
Siemens Healthcare Diagnostics is recalling 3,318 units of the IMMULITE 2000 Intact PTH assay over the potential for falsely depressed patient results at the low end of the assay range.
Product
Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN): (1) 10381441, (2) 10381442; Catalog Number: (1) L2KPP2, (2) L2KPP6;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0312-2026·2025-11-05
Reducing converters recalled over silicone fragments detaching from sealing component
Aesculap is recalling 155 reducing converters because silicone fragments may detach from the yellow sealing component.
Product
Brand Name: AESCULAP Product Name: REDUCING CONVERTER 10/12MM TO 5MM Model/Catalog Number: EK087P Software Version: N/A Product Description: REDUCING CONVERTER 10/12MM TO 5MM Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0369-2026·2025-11-05
Pyxis Pro auxiliary drawers recalled over fluid ingress causing smoke or fire
CareFusion is recalling 32 BD Pyxis Pro 7-Drawer Auxiliary units because potential fluid ingress of the anesthesia or med station may result in smoke, system downtime and/or fire.
Product
Various models of BD Pyxis Pro 7-Drawer Auxiliary, Reference numbers: 1149-00 and 1152-00
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0358-2026·2025-11-05
Chemotherapy extension sets recalled because port weld may separate during use
ICU Medical is recalling 2,450 8-inch extension sets with ChemoLock port because the port weld of the drug transfer device may separate or break during use and leak.
Product
ICU Medical 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating Luer, REF: CL-3950
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0335-2026·2025-11-05
Bag spikes with Clave additive port recalled over port weld separation
ICU Medical is recalling 3,000 ChemoLock Bag Spikes with Clave additive port because the port weld of the drug transfer device may separate or break during use and leak.
Product
ICU Medical ChemoLock Bag Spike with Clave Additive Port REF: CL3940
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0341-2026·2025-11-05
Chemotherapy bag spikes recalled because port weld may separate and leak
ICU Medical is recalling 7,850 ChemoLock Bag Spikes because the port weld of the drug transfer device may separate or break during use and leak.
Product
ICU Medical ChemoLock Bag Spike REF: CL-10
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0409-2026·2025-11-05
Dialysis connectivity software recalled because prescription changes may not reach cyclers
Vantive is recalling the Sharesource Connectivity Platform for Homechoice Claria because a software defect may stop updated prescription settings from saving on the patient's cycler.
Product
Sharesource Connectivity Platform for Use with Homechoice Claria Product Code 5CGM01 software versions 7.13.3 (China), 8.13.2 (APAC and Korea), and 8.13.4 (US, EMEA, and LATAM)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0359-2026·2025-11-05
Purple cap administration sets recalled over port weld separation risk
ICU Medical is recalling 11,000 31-inch administration sets with an integrated ChemoLock drip chamber because the port weld may separate or break during use and leak.
Product
ICU Medical 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Purple Cap, Hanger REF: CL3951
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0345-2026·2025-11-05
13mm vented vial spikes recalled over port weld separation risk
ICU Medical is recalling 9,004 ChemoLock Vented Vial Spikes, 13mm, because the port weld of the drug transfer device may separate or break during use and leak.
Product
ICU Medical ChemoLock Vented Vial Spike, 13mm REF: CL-72
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0326-2026·2025-11-05
Daily contact lenses recalled over a weak seal compromising sterility
Alcon Research is recalling 82 units of PRECISION1 One-Day Contact Lenses in -2.25D because some units may have a weak seal that compromises sterility.
Product
Alcon PRECISION1 One-Day Contact Lenses, -2.25D.
Category
Medical Device
Distribution
19 states
HighFDA (Devices)·Z-0322-2026·2025-11-05
SyncAR navigation platform recalled over image layer misalignment in 2D fusion
Surgical Theater is recalling 14 units of its SyncAR SNAP platform because a software anomaly may misalign secondary image layers against the primary layer.
Product
SyncAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SNP.1.12.0, imaging processing radiological system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0347-2026·2025-11-05
ChemoLock vial spikes recalled because port weld may separate and leak
ICU Medical is recalling 53,050 ChemoLock 20mm Vial Spikes because the port weld of the drug transfer device may separate or break during use and leak.
Product
ICU Medical ChemoLock Vial Spike, 20mm REF: CL-80S
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0352-2026·2025-11-05
Graduated connectors recalled because port weld may separate and leak
ICU Medical is recalling 1,700 Graduated Connectors with ChemoLock port because the port weld of the drug transfer device may separate or break during use and leak.
Product
ICU Medical Graduated Connector w/ChemoLock Port REF: CL3900
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0370-2026·2025-11-05
Pyxis Pro MedStation units recalled over fluid ingress causing smoke or fire
CareFusion is recalling 27 BD Pyxis Pro MedStation Main units because potential fluid ingress of the anesthesia or med station may result in smoke, system downtime and/or fire.
Product
BD Pyxis Pro MedStation Main, REF: 1155-00
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0363-2026·2025-11-05
ChemosafeLock bag spikes recalled over port weld separation risk
ICU Medical is recalling 134,700 ChemosafeLock Bag Spikes because the port weld of the drug transfer device may separate or break during use and leak.
Product
ICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0350-2026·2025-11-05
ChemoLock ports recalled because the port weld may separate and leak
ICU Medical is recalling 133,255 ChemoLock Ports because the port weld of the drug transfer device may separate or break during use and leak.
Product
ICU Medical ChemoLock Port REF: CL2100
Category
Medical Device
Distribution
Distributed nationwide

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