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

11101–11125 of 27441

HighFDA (Devices)·Z-2293-2021·2021-08-25
Gore Propaten Vascular Graft Pediatric Shunt Diameter Labeling Error
W L Gore is recalling certain Gore Propaten Vascular Grafts for pediatric shunts due to incorrect diameter labeling. Grafts labeled as 5 mm may actually be 6 mm and vice versa.
Product
Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 6 mm, Length 15 cm, Rx Only, Sterile EO, for the following Reference numbers: HPT060015 UDI: (01)00733132606368 HPT060015A UDI: (01)00733132606375
Category
Medical Device
Distribution
10 states
HighFDA (Devices)·Z-2306-2021·2021-08-25
Philips EPIQ Ultrasound Systems Control Panel Arm Swivel Lock May Fail
Philips EPIQ ultrasound system control panel arm swivel locks can fail, allowing the monitor to swivel freely during positioning or transport, potentially causing user or patient musculoskeletal injury.
Product
EPIQ Ultrasound Systems, Model: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx, EPIQ CVxi
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2312-2021·2021-08-25
NEO-KATH Epidural Catheter Set recalled for potential stylet protrusion
Epimed International recalls NEO-KATH Epidural Catheter Set (Lot 16308275, 16308382) due to potential stylet protrusion from the catheter distal end, which poses injury risk during epidural procedures.
Product
NEO-KATH Epidural Catheter Set, REF 200-2430, Sterile
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-2301-2021·2021-08-25
NEO DELTA Self Safe T IV Catheters Recalled for Sterilization Failure
NEO DELTA Self Safe T IV catheters may lack sterility due to sterilization problems. The FDA is recalling 20,000 units distributed in Florida and Minnesota.
Product
NEO DELTA Self Safe T, I.V. catheter of PUR a) REF 3779422 b) REF 3769522 c) REF 3708522
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2310-2021·2021-08-25
OPTI SARS-CoV-2 RT-PCR Test Kits Recalled for False Positive Results
OPTI Medical Systems is recalling COVID-19 test kits due to a precipitation issue that may cause false positive results in 5-10% of affected vials. No illnesses have been reported.
Product
OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004
Category
Medical Device
Distribution
10 states
HighFDA (Devices)·Z-2299-2021·2021-08-25
I.V. Catheter Recall: Sterilization Defects in NEO DELTA Self Safe Devices
Delta Med is recalling 10,000 units of NEO DELTA Self Safe I.V. Catheters due to sterilization defects. Affected devices were distributed in Florida and Minnesota.
Product
NEO DELTA Self Safe, I.V. Catheter REF 3738222
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2317-2021·2021-08-25
IQon Spectral CT System Software Error Increases Contrast Volume
Philips IQon Spectral CT systems can recommend excessive contrast volume when patient weight is set to pounds due to a SynchRight software calculation error, potentially resulting in patient overdose.
Product
728332 IQon Spectral CT-Computed Tomography X-ray system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2307-2021·2021-08-25
Oxygen Sensors in Incubators May Display Inaccurate Readings
CooperSurgical oxygen sensors in incubators may display inaccurate oxygen readings that do not trigger alarms when discrepancies occur. This could result in loss of embryos during storage.
Product
Oxygen Sensor Model K54019-2 used in the: G185 & G210 Incubators and G603 Work Chambers Oxygen Sensors supplied for use in the following incubator and work chamber products; G185 Standard 110V, G185 SensorTech 110V, G185 Standard 230V, G185 SensorTech 230V, G210 InviCell…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2318-2021·2021-08-25
CT X-ray System Software Miscalculates Contrast Volume with Pounds Unit Setting
Philips 728333 Spectral CT 7500 systems with SynchRight software may incorrectly calculate and recommend increased contrast volume when patient weight is set to pounds. Affected system should be updated to prevent excess contrast dosing.
Product
728333 Spectral CT 7500 -Computed Tomography X-ray system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2311-2021·2021-08-25
Cell Marque Antibody Reagents Recalled for Incorrect Expiry Date Labeling
Cell Marque antibody reagents used in pathology are recalled for labeling an incorrect expiry date (December 31, 2023 instead of December 31, 2022). Using expired reagent may result in weak or absent staining and false negative test results.
Product
Cell Marque Antibodies, PSA (ER-PR8) Mouse Monoclonal Antibody, REF: 324M-15, 324M-16
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2294-2021·2021-08-25
Soltive Laser Systems recalled for thermal burn injury risk during stone treatment
Olympus is recalling Soltive laser systems used in urological surgery because exceeding recommended power settings can cause thermal burns to tissue during kidney stone treatment.
Product
Soltive Premium Super Pulsed Laser System (TFL-PLS) & Pro Super Pulsed Laser System (TFL-SLS). Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in urology, lithotripsy…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2323-2021·2021-08-25
Cytocell DNA Diagnostic Probe Recalled for Unexpected Chromosomal Signals
Cytocell Ltd. is recalling a DNA diagnostic probe that may produce unexpected signals at additional chromosomal locations during testing. The affected probe is an in vitro diagnostic reagent used in laboratory cytogenetic analysis.
Product
Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2328-2021·2021-08-25
TheraSphere Administration Set may leak or loosen at catheter connection
Boston Scientific is recalling TheraSphere Administration Sets due to potential leaks and loosening at the patient catheter connection. Approximately 4,200 sets were distributed worldwide.
Product
TheraSphere Administration Set, REF OTT-SPE-FP-001 (990264.SPE)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2305-2021·2021-08-25
FDA Recalls WOLF-PAK IV Catheters Due to Sterilization Problems
Delta Med SpA is recalling WOLF-PAK Self Safe Safety IV Catheters due to sterilization defects affecting approximately 40,000 units in Florida and Minnesota.
Product
WOLF-PAK Self Safe Safety IV Catheter: a) REF PIVD2010W b) REF PIV2210W c) REF PIV2475W
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2321-2021·2021-08-25
RUSCH Endotracheal Tubes Recalled for Potential Cuff Inflation Malfunction
Teleflex Medical Europe is recalling RUSCH endotracheal tubes because the cuff can inflate without the pilot balloon showing proper inflation. This defect could prevent clinicians from verifying correct cuff function.
Product
RUSCH Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF numbers: a) 112080050 b) 112080055 c) 112080060 d) 112080065 e) 112080070 f) 112080075 g) 112080080 h) 112080085 i) 112080090 j) 112080095 k) 112080100
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2327-2021·2021-08-25
TheraSphere Administration Set recalled for potential leaks at catheter connection
Boston Scientific is recalling TheraSphere Administration Sets due to potential for leaks and loosening at the patient catheter connection. The recall affects 4980 sets distributed worldwide.
Product
TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2320-2021·2021-08-25
RUSCH Flexi-Set Endotracheal Tube Cuff May Inflate Without Pilot Balloon Response
Teleflex Medical Europe Ltd is recalling RUSCH Flexi-Set Cuffed Endotracheal Tubes nationwide because the cuff can inflate while the pilot balloon remains flat, preventing proper verification of cuff status.
Product
RUSCH Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 504550 b) 504555 c) 504560 d) 504565 e) 504570 f) 504575 g) 504580 f) 504585 g) 504590
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2324-2021·2021-08-25
CIRCUL8 LUXE DVT Prevention Device Marketed Without FDA Clearance
The CIRCUL8 LUXE DVT Prevention Device is being recalled because it was marketed without FDA clearance. The device is intended to aid in the prevention of deep vein thrombosis.
Product
CIRCUL8 LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF: 08-0020, Rx Prescription Only, Not Sterile IP22, Latex Free,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2287-2021·2021-08-25
Trilogy Evo Ventilator Software Defect May Cause Pressure Increase
Philips Respironics recalls Trilogy Evo ventilators due to software issues that may increase pressure delivery to patients. The defect affects multiple product variants worldwide.
Product
Trilogy Evo, Product numbers BL2110X15B, CA2110X12B, DE2110X13B, DS2110X11B, EE2110X15B, ES2110X15B, EU2110X15B, EU2110X19, FR2110X14B, GB2110X15B, IA2110X15B, IN2110X15B, IN2110X19, IT2110X21B, KR2110X15B, LA2110X15B, LD2110X23B, ND2110X15B, RDE2110X13B, UDS2110X11B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2295-2021·2021-08-25
FDA Recalls DELTAVEN Safety I.V. Catheters Due to Sterilization Defect
Delta Med SpA recalls 30,900 DELTAVEN Safety I.V. Catheters in Florida and Minnesota due to potential sterilization failures that could compromise device sterility.
Product
DELTAVEN Safety I.V. Catheter in Pur with closed system: a) REF 3836272 b) REF 3814272 c) REF 3845272 d) REF 3856272
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2316-2021·2021-08-25
CT system software error recommends excessive contrast volume
A software defect in Philips CT imaging systems causes incorrect contrast volume calculations when patient weight units are set to pounds, resulting in increased contrast dosing recommendations. Three units with specific serial numbers are affected.
Product
728327 Ingenuity CT Upgrades-Computed Tomography X-ray system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2314-2021·2021-08-25
Brilliance iCT Computed Tomography Systems Recalled for Contrast Dosing Error
Philips Brilliance iCT CT systems with SynchRight P3T software may recommend incorrect contrast volume when patient weight is entered in pounds, potentially affecting patient safety.
Product
728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2290-2021·2021-08-25
Trilogy Evo Respiratory Device Recalled for Software Pressure Issues
Philips Respironics has recalled Trilogy Evo Universal respiratory devices (model DS2000X11B) for software defects that increase pressure, particularly in pediatric and infant applications.
Product
Trilogy Evo Universal, Product number DS2000X11B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2304-2021·2021-08-25
I.V. Catheter Recall Due to Possible Sterilization Failure
Delta Med recalls NEO DELTA SELFSAFE PUR T I.V. catheters distributed in Florida and Minnesota due to sterilization problems. Non-sterile catheters pose infection risks.
Product
NEO DELTA SELFSAFE PUR T, I.V. Catheter:
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2288-2021·2021-08-25
Trilogy Evo O2 Ventilator Software Issues Affecting Pressure Delivery
Philips Respironics is recalling Trilogy Evo O2 ventilators with software issues that can increase pressure delivery. One issue affects infant/pediatric settings; another causes pressure drift during continuous use.
Product
Trilogy Evo O2, Product numbers DE2100X13B, DS2100X11B, EE2100X15B, ES2100X15B, EU2100X15B, FR2100X14B, FX2100X15B, IA2100X15B, IN2100X15B, IN2100X19, IT2100X21B, JP2100X16B, LA2100X15B, ND2100X15B, RDE2100X13B, SP2100X26B
Category
Medical Device
Distribution
Distributed nationwide

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11101–11125 of 27441