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

2651–2675 of 39987

HighFDA (Devices)·Z-0367-2026·2025-11-05
Pyxis Medbank units recalled over fluid ingress causing smoke or fire
CareFusion is recalling 8,262 BD Pyxis Medbank 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 Medbank: Reference numbers: 1137-00 1145-00 1146-00 1147-00 1148-00 138902-01 138903-01 138905-01 138906-01 138907-01 138908-01 138909-01 138910-01 138911-01 138912-01 138913-01 138914-01 138915-01 138916-01 138917-01 138918-01 13
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-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-0328-2026·2025-11-05
Single unit bag spikes recalled over port weld separation risk
ICU Medical is recalling 875 single-unit ChemoLock Bag Spikes because the port weld of the drug transfer device may separate or break during use and leak.
Product
ChemoLock Bag Spike, 01 units REF: CL-10-10
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-0353-2026·2025-11-05
Bag spikes with additive port recalled over port weld separation risk
ICU Medical is recalling 6,450 6.5-inch bag spikes with ChemoLock additive port because the port weld of the drug transfer device may separate or break during use and leak.
Product
ICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port REF: CL3955
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-0414-2026·2025-11-05
Nasal test kits recalled after a false negative on a positive sample
Cepheid is recalling 4,132 Xpert SA Nasal Complete kits after post-market half-time stability testing produced a false negative result for a positive sample type.
Product
Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Xpert SA Nasal Complete kit; 10 test kit: A collection of reagents and other associated materials intended to be used for the direct qualitative and/or quantitative detection of nucleic acid from
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0410-2026·2025-11-05
Intraoperative ultrasound systems recalled over soldering that can shut them down
Medistim is recalling 14 MiraQ ultrasound systems because insufficient soldering in the Printer Support Module may loosen wires and cause the system to shut down.
Product
Brand Name: Medistim MiraQ System Product Name: Medistim MiraQ System Model/Catalog Number: MQC04001, MQC14001, MQU14011, MQV12011 Software Version: Not applicable Product Description: Ultrasound device for intraoperative use Component: No
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-0321-2026·2025-11-05
Surgical imaging software recalled over image layer misalignment in 2D fusion
Surgical Theater is recalling 50 units of its PE SNAP imaging platform because a software anomaly may misalign secondary image layers against the primary layer.
Product
Surgical Navigation Advanced Platform Patient Engagement (PE SNAP), software version SNP.3.12.0, imaging processing radiological system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0365-2026·2025-11-05
Chemotherapy vial adapters recalled because port weld may separate and leak
ICU Medical is recalling 202,900 ChemosafeLock Vial Adapters because the port weld of the drug transfer device may separate or break during use and leak.
Product
ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3
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-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-0317-2026·2025-11-05
Magseed Pro 12 cm markers recalled over potential cotton fiber contamination
Endomagnetics is recalling 540 Magseed Pro 12 cm soft tissue markers because of the potential for contamination with cotton fibers.
Product
Magseed Pro 12 cm soft tissue marker. Model Number: MS2-17-1-12. Product Description: The Endomag Magseed Pro Magnetic Marker System is a sterile, single use device composed of a marker preloaded in a 17ga Needle Delivery System. The Endomag Magseed Pro Marker is indicated for
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0331-2026·2025-11-05
Clave bag spikes recalled because port weld may separate and leak
ICU Medical is recalling 200 Clave Bag Spikes with ChemoLock port because the port weld of the drug transfer device may separate or break during use and leak.
Product
ICU Medical Clave Bag Spike w/ChemoLock Port REF: CL2150
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0351-2026·2025-11-05
21 inch extension sets recalled over port weld separation risk
ICU Medical is recalling 950 21-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 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: CL3360
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-0311-2026·2025-11-05
Trocar sealing units recalled over silicone fragments detaching from sealing component
Aesculap is recalling 26 sealing units for 10/12mm trocars because silicone fragments may detach from the yellow sealing component.
Product
Brand Name: AESCULAP Product Name: SEALING UNIT FOR 10/12MM TROCARS Model/Catalog Number: EK086P Software Version: N/A Product Description: SEALING UNIT FOR 10/12MM TROCARS Component: N/A
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
HighFDA (Devices)·Z-0375-2026·2025-11-05
CT scanners recalled over six software faults affecting movement and dose
Philips Medical Systems is recalling 105 Incisive CT scanners 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; Product Code (REF): (1) 728143, (2) 728144; Software Versions: 5.1.0.X & 5.1.1.X;
Category
Medical Device
Distribution
18 states
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-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-0333-2026·2025-11-05
Chemotherapy administration sets recalled because port weld may separate and leak
ICU Medical is recalling 7,950 20-drop administration sets with an integrated ChemoLock port because the port weld of the drug transfer device may separate or break during use and leak.
Product
ICU Medical 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/Integrated ChemoLock Port Drip Chamber, ChemoLock w/Red Cap, Bag Hanger REF: CL3511
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0349-2026·2025-11-05
13mm closed vial spikes recalled because port weld may separate and leak
ICU Medical is recalling 3,350 ChemoLock 13mm Closed Vial Spikes because the port weld of the drug transfer device may separate or break during use and leak.
Product
ICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0334-2026·2025-11-05
Oncology kits with vented vial spike recalled over port weld failure
ICU Medical is recalling 1,100 Oncology Kits containing a ChemoLock Universal Vented Vial Spike because the port weld of the drug transfer device may separate or break and leak.
Product
ICU Medical Oncology Kit w/31" (79 cm) 20 Drop Admin Set w/Integrated ChemoLock" Port Drip Chamber, Spiros"; ChemoLock"; ChemoLock" Universal Vented Vial Spike; Bag Hanger REF: CL3929
Category
Medical Device
Distribution
Distributed nationwide

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2651–2675 of 39987