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

13201–13225 of 13836

HighFDA (Devices)·Z-2297-2021·2021-08-25
IV Catheters recalled due to potential sterilization failure
229,320 DELTAVEN FASTFLASH IV catheters distributed in Florida and Minnesota are being recalled due to sterilization defects. The medical devices may not be sterile, posing contamination and infection risks to patients.
Product
DELTAVEN FASTFLASH, Safety I.V. Catheter in Pur with closed system: a) REF 3814773 b) REF 3835773 c) REF 3825773 d) REF 3837773 e) REF 3846773 f) REF 3831473 g) REF 3842473 h) REF 3821473 i) REF 3832473 j) REF 3833473 k) REF 3821573 l) REF 3831573 m) REF 3833573 n)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2308-2021·2021-08-25
Hitachi L43K intraoperative probe recall: screw cover may detach during sterilization
Hitachi Healthcare is recalling 120 Model L43K intraoperative probes because the screw cover at the probe tip may fall off after cleaning and sterilization. Facilities should inspect probes before and after sterilization and before and after each surgical use.
Product
Model L43K Intraoperative Probe-For the diagnostic ultrasound evaluation during robotic/non-robotic intra-operative and laparoscopic procedures
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2313-2021·2021-08-25
NEO-KATH Caudal Catheter Set Recalled Due to Stylet Protrusion Risk
Epimed International is recalling the NEO-KATH Caudal Set (REF 201-2430) because the stylet may protrude from the catheter's tip, potentially causing tissue injury. The recall affects 140 units distributed in the US and internationally.
Product
NEO-KATH(TM) Caudal Set, REF 201-2430, Sterile
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-2298-2021·2021-08-25
DELTAVEN Y IV Catheters Recalled Over Potential Sterilization Defect
Delta Med is recalling DELTAVEN Y IV Catheters in Florida and Minnesota due to potential sterilization defects. The devices may not be properly sterilized, posing infection risks to patients.
Product
DELTAVEN Y, Safety I.V. Catheter in Pur with closed system a) REF 3832072 b) REF 3810072 c) REF 3842072 d) REF 3852072
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2322-2021·2021-08-25
RUSCH Endotracheal Tube Cuff Inflation Malfunction Without Pilot Balloon Indication
Teleflex recalls RUSCH endotracheal tubes because the cuff can be inflated while the pilot balloon remains flat, preventing proper monitoring of cuff pressure.
Product
RUSCH Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF numbers: a) 112082050 b) 112082055 c) 112082060 d) 112082065 e) 112082070 f) 112082075 g) 112082080 h) 112082085 i) 112082090 j) 112082095 k) 112082100
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2302-2021·2021-08-25
I.V. Catheter Recall Due to Sterilization Failures
Delta Med is recalling approximately 1,400 NEO DELTA SELFSAFE PUR 1 I.V. catheters (Lot 00A1160806) distributed in Florida and Minnesota due to sterilization process defects that may result in non-sterile devices.
Product
NEO DELTA SELFSAFE PUR 1, I.V. Catheter, REF 3718122
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2319-2021·2021-08-25
RUSCH Slick Set Cuffed Endotracheal Tubes Recalled for Improper Cuff Inflation
Teleflex Medical Europe Ltd. is recalling RUSCH Slick Set Cuffed Endotracheal Tubes because the cuff can inflate while the pilot balloon remains flat, potentially affecting airway pressure monitoring.
Product
RUSCH Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 170050 b) 170055 c) 170060 d) 170065 e) 170070 f) 170075 g) 170080 h) 170085 i) 170090 j) 170095
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2329-2021·2021-08-25
Triathlon orthopaedic implant baseplate recalled for assembly defect
Howmedica Osteonics is recalling the Triathlon Prim CEM baseplate (Lot JHS2H) due to a manufacturing defect that may prevent the insert from locking properly on the implant.
Product
Triathlon Prim CEM FXD BPLT 7, Catalog No. 5520B700
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2300-2021·2021-08-25
IV Catheters Recalled Due to Possible Missing Sterility
Delta Med SpA is recalling NEO DELTA Self Safe 1 IV catheters due to possible missing sterility. The recall affects 5,000 units distributed in Florida and Minnesota.
Product
NEO DELTA Self Safe 1, I.V. Catheter with PUR REF 3708122, Lot 00A1160627 5000 units
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2292-2021·2021-08-25
Gore Propaten Vascular Graft Pediatric Shunt Dimension Labeling Error Recall
W L Gore & Associates is recalling Gore Propaten Vascular Grafts for pediatric shunts due to incorrect diameter labeling: grafts with 6mm inner diameter are labeled 5mm, and those with 5mm diameter are labeled 6mm.
Product
Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 5 mm, Length 10 cm, Rx Only, Sterile EO, for the following Reference numbers: HPT050010 UDI: (01)00733132606320 HPT050010A UDI: (01)00733132606337
Category
Medical Device
Distribution
10 states
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, gastroenterologica
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2296-2021·2021-08-25
FDA Recalls DELTAVEN Y Safety IV Catheters Due to Sterilization Issues
Delta Med SpA is recalling DELTAVEN Y DNL Safety IV Catheters with closed system due to sterilization problems. The recalled units may lack proper sterility and pose a risk to patients.
Product
DELTAVEN Y DNL Safety I.V. Catheter in Pur with closed system: a) REF 3832572 b) REF 3842572 c) REF 3821572 d) REF 3833572 e) REF 3831572 f) REF 3810572 g) REF 3852572
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-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-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-2326-2021·2021-08-25
Surgical stapler mislabeled with incorrect device size
Ethicon is recalling ECHELON FLEX Powered Plus Staplers because the product packaging is mislabeled; packages labeled as 60mm contain 45mm devices, which could affect surgical outcomes if the incorrect size is used.
Product
ECHELON FLEX Powered Plus Stapler-intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. Product Code: PSEE60A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2289-2021·2021-08-25
Trilogy EV300 Ventilator Recalled for Software-Related Pressure Calibration Issues
Philips Respironics is recalling the Trilogy EV300 ventilator due to software issues causing pressure calibration errors affecting infant and pediatric patients. The defects impact 18,936 units distributed in the United States.
Product
Trilogy EV300, Product numbers CA2200X12B, DS2200X11B, FX2200X15B, IN2200X15B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2315-2021·2021-08-25
CT5000 X-ray System Contrast Dose Calculation Error Under Pounds Setting
Philips CT5000 X-ray systems may incorrectly calculate contrast volume doses when patient weight units are set to pounds. The software error could recommend higher-than-intended contrast volumes.
Product
Model 728321/728323 CT5000 Ingenuity Plus/Pro/Premium-Computed Tomography X-ray system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2291-2021·2021-08-25
Tornier Aequalis Pyrocarbon shoulder implants recalled for potential graphite exposure
Tornier recalls Aequalis Pyrocarbon shoulder implants (6,631 units) due to potential patient exposure to graphite substrate material. The units were distributed across multiple U.S. states.
Product
The Aequalis Pyrocarbon Humeral Heads. Shoulder implant component. Sold OUS only: a) Catalog # DWH039 - Diameter 39 mm Height 14 mm Eccentric LOW (1.5) Material PyC/CoCr, b) Catalog # DWH041 - Diameter 41 m m Height 15 mm Eccentric LOW (1.5) Material PyC/CoCr, c) Catalog
Category
Medical Device
Distribution
15 states
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-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-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-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-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-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

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13201–13225 of 13836