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

376–400 of 5100

CriticalFDA (Devices)·Z-0586-2026·2025-12-10
Infusion pump administration sets recalled over incorrect assembly of one lot
Fresenius Kabi USA is recalling 483 cases of Ivenix LVP Primary Administration Sets after incorrect assembly of a specific lot that the firm states could result in serious patient injury.
Product
IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Large Volume Infusion Pump Administration Set.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0570-2026·2025-12-03
Ligating devices recalled because the loop may not release as expected
Olympus is recalling 7,803 Single Use Ligating Devices because the ligation loop may fail to release or detach, leaving it unintentionally fixed around patient anatomy.
Product
Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Model/Catalog Number: HX-400U-30 Used with an Olympus endoscope to deliver a nylon loop snare.
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-0532-2026·2025-12-03
Smaller pericardial patches recalled over a tensile strength specification failure
Glycar SA is recalling 18 SJM Pericardial Patches, 5 x 10 cm, because the impacted lot may not meet the required tensile strength specification. The FDA classified it Class I.
Product
SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-0531-2026·2025-12-03
Pericardial patches recalled because a lot may not meet tensile strength
Glycar SA is recalling 30 SJM Pericardial Patches with EnCap Technology because the impacted lot may not meet the required tensile strength specification. The FDA classified it Class I.
Product
SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0579-2026·2025-12-03
Duodenoscopes recalled after continued reports of positive cultures and infections
Olympus is recalling 7,023 EVIS EXERA III TJF-Q190V duodenovideoscopes after continued reports of positive cultures and infections, and is updating the reprocessing materials.
Product
Brand Name: EVIS EXERA III Duodenovideoscope Product Name: Olympus TJF-Q190V Model/Catalog Number: TJF-Q190V Product Description: This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessorie
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0430-2026·2025-11-26
Infusion pump modules recalled because drops can damage the bezel assembly
CareFusion is recalling 2,574,396 BD Alaris Infusion Pump Modules 8100 because a dropped or jarred pump can suffer bezel damage causing under-infusion, over-infusion or unregulated flow.
Product
BD Alaris infusion Pump Module 8100, REF: 8100; KIT, BEZEL ASSY 8100BD, REF: 49000437; KIT ASSY ONE PIECE BEZEL 8100, REF: 49000270. Used with the following new and updated documents: BD Alaris Infusion System Inspection Safety Reminder, Part: BD-163124, Revision: 00; Clean
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0488-2026·2025-11-26
Jaw joint implants recalled over a discrepancy in screw hole position
TMJ Solutions is recalling 63 TMJ Bilateral Implants because the patient-fitted temporomandibular joint implant contained a discrepancy in screw hole position. The FDA classified it Class I.
Product
TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only
Category
Medical Device
Distribution
15 states
CriticalFDA (Devices)·Z-0447-2026·2025-11-19
Surgical convenience kits recalled over cracked anesthesia circuit tubing
Medline is recalling 96,406 breast and hernia convenience kits after complaints of anesthesia circuit leaks caused by cracks in the 120-inch expandable tubing. The FDA classified it Class I.
Product
Convenience Kit, BREAST HERNIA DYNJ909125G
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0451-2026·2025-11-19
Orthopedic and spine kits recalled over cracked anesthesia circuit tubing
Medline is recalling ortho spine, total joint and kyphoplasty convenience kits after complaints of anesthesia circuit leaks from cracks in the 120-inch expandable tubing. The FDA classified it Class I.
Product
Convenience kits; DYNJ901047R ORTHO SPINE FUMICH DYNJ902308K TOTAL JOINT DYNJ909111F DR SALMA'S SPINE DYNJ909117G PATTERSON TOTAL JOINT DYNJ909113F KYPHOPLASTY
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0445-2026·2025-11-19
Airway procedure kits recalled over cracks in anesthesia circuit tubing
Medline is recalling ENT and laryngoscopy-bronchoscopy kits containing anesthesia circuits after complaints of leaks from cracks in the 120-inch expandable tubing. The FDA classified it Class I.
Product
Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; ENT DYNJ909128I; LARYNGOSCOPY - BRONCHOSCOPY DYNJ909114D
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0431-2026·2025-11-19
MRI upgrade recalled over ice blockage in helium venting paths
Siemens Medical Solutions is recalling four MAGNETOM Cima.X Upgrade systems because an ice blockage may form in the magnet's helium venting paths. The FDA has classified it Class I.
Product
MAGNETOM Cima.X Upgrade. Model Number: 11689304.
Category
Medical Device
Distribution
1 state
CriticalFDA (Devices)·Z-0443-2026·2025-11-19
Breathing kits recalled over cracks in the expandable anesthesia tubing
Medline is recalling the latex-free Breathing Kit DYNJ10550 after complaints of anesthesia circuit leaks caused by cracks in the 120-inch expandable tubing. The FDA classified it Class I.
Product
Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; BREATHING KIT-LF DYNJ10550
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0448-2026·2025-11-19
Urology and hip pinning kits recalled over cracked anesthesia circuit tubing
Medline is recalling ortho spine, urology minor, set up and hip pinning convenience kits after complaints of anesthesia circuit leaks from cracked tubing. The FDA classified it Class I.
Product
Convenience Kits: DYNJ901048N ORTHO SPINE ST CLAIR DYNJ909123F UROLOGY MINOR DYNJ909132F SET UP DYNJ909308D HIP PINNING
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0442-2026·2025-11-19
Adult anesthesia circuit kits recalled over cracked expandable tubing
Medline is recalling multiple adult 120-inch expandable anesthesia circuits after complaints of leaks caused by cracks in the tubing. The FDA has classified it Class I.
Product
Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; Product description/Product numbers: ADULT 120 EXPANDABLE W/MASK DYNJAA10591; ANES CIRC 120IN EXP-LF DYNJAA6555G; ANES CIRCUIT ADULT 120"-LF DYNJAA10817; ANESTHESIA 120" ADLT-LF DYNJAA10
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0444-2026·2025-11-19
Open heart and vascular kits recalled over cracked anesthesia circuit tubing
Medline is recalling open heart supplement and vascular kits containing anesthesia circuits after complaints of leaks from cracks in the 120-inch expandable tubing. The FDA classified it Class I.
Product
Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; OPEN HEART SUPPLEMENT DYNJ909116D; VASCULAR DYNJ909124F
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0446-2026·2025-11-19
Laparoscopy and cysto kits recalled over cracked anesthesia circuit tubing
Medline is recalling robotic gastric sleeve, cysto and general laparoscopy kits after complaints of anesthesia circuit leaks from cracks in the 120-inch expandable tubing. The FDA classified it Class I.
Product
DYNJ909119G ROBOTIC GASTRIC LAP SLEEVE-LF DYNJ909127F CYSTO DYNJ909129D GENERAL LAPAROSCOPY-LF
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0450-2026·2025-11-19
Robotic surgery kits recalled over cracked anesthesia circuit tubing
Medline is recalling GYN Robotic and Robotic Prostate convenience kits after complaints of anesthesia circuit leaks caused by cracks in the 120-inch expandable tubing. The FDA classified it Class I.
Product
Convenience kits; DYNJ901046M GYN ROBOTIC DYNJ909120D ROBOTIC PROSTATE
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0434-2026·2025-11-19
Detachable brain aneurysm coils recalled because they may fail to detach
Cerenovus is recalling 12,004 CEREPAK Detachable Coil System units because the coils may fail to detach, which could result in hemorrhagic and ischemic stroke. The FDA classified it Class I.
Product
CEREPAK Detachable Coil System - Name/REF: UNIFORM 2MM X 2.5 CM/FCX100202, UNIFORM 2.5MM X 3.3 CM/FCX100253, UNIFORM 3MM X 5.4 CM/FCX100305, UNIFORM 3.5MM X 6.6 CM/FCX100356, UNIFORM 4MM X 7.5 CM/FCX100407, UNIFORM 4MM X 11.5 CM/FCX100412, UNIFORM 5MM X 9.7 CM/FCX100509, UNIFORM
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0449-2026·2025-11-19
Expandable anesthesia circuits recalled over cracks causing leaks in tubing
Medline is recalling the 120-inch latex-free ExtendFlex anesthesia circuit after complaints of leaks caused by cracks in the expandable tubing. The FDA has classified it Class I.
Product
Anesthesia circuit kit; CIRCUIT,ANES,EXTENDFLEX,120,LF DYNJAA10230
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0427-2026·2025-11-12
Insulin pumps recalled over false vibration motor failure stopping delivery
Tandem Diabetes Care is recalling 17,745 Tandem Mobi insulin pumps because a software issue can trigger a false vibration motor failure that halts insulin delivery. The FDA classified it Class I.
Product
Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism to deliver insulin from within a disposable cartridge, through an infusion set,
Category
Medical Device
Distribution
53 states
CriticalFDA (Devices)·Z-0374-2026·2025-11-12
Cranial perforators recalled as inadequate weld recall expands to smaller sizes
Integra LifeSciences is recalling 5,109 CODMAN Disposable Perforators, 9mm, extending an existing 14 mm recall for inadequate welds. The FDA has classified it Class I.
Product
CODMAN Disposable Perforator 9mm. Cranial Perforator.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0373-2026·2025-11-12
Eleven millimetre cranial perforators recalled over inadequate welds
Integra LifeSciences is recalling 16,251 CODMAN Disposable Perforators, 11mm, extending an existing 14 mm recall for inadequate welds. The FDA has classified it Class I.
Product
CODMAN Disposable Perforator 11mm. Cranial Perforator.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0188-2026·2025-11-05
Distal access catheters recalled after coating material lifting inside the lumen
Balt USA is recalling 207 MEGA Ballast Distal Access Platform catheters over a manufacturing defect in which coating material lifts within the catheter's distal lumen. The FDA has classified it Class I.
Product
Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: MEGABT09180, MEGABT09190, MEGABT091100, MEGABT091110 Software Version: N/A Product Description: The Mega Ballast 091 is designed with a semi-rigid proximal shaft and a highly flex
Category
Medical Device
Distribution
12 states
CriticalFDA (Devices)·Z-0318-2026·2025-11-05
Glucose monitoring app recalled because it can terminate and miss alerts
Dexcom is recalling version 1.15.0 of the G6 and G6 Pro Android CGM app because a software defect can terminate the app, stopping glucose values, alarms and alerts. The FDA classified it Class I.
Product
Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and G6 Pro Android US CGM App Model/Catalog Number: SW11678 Software Version: version 1.15.0 Product Description: Dexcom G6 and G6 Pro Android US CGM App SW11678 version 1.15.0 Component: Dexc
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-0161-2026·2025-11-05
Neuro operating suites recalled over ice blockage in magnet venting paths
IMRIS is recalling the Neuro III-SV iMRI and iMRX systems because an ice blockage in the Siemens 3 Tesla Verio magnet's venting system could rupture the helium containment system during a quench.
Product
IMRIS Operating Suite, Neuro III-SV iMRI System, iMRX System, containing Siemens 3 Tesla MRI Magnet, Verio
Category
Medical Device
Distribution
Distributed nationwide

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