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

10051–10075 of 39932

HighFDA (Devices)·Z-1647-2023·2023-06-07
Philips Azurion X-ray Systems May Lose Imaging Capability When Storage Full
Philips Azurion X-ray imaging systems may suddenly lose X-ray functionality when disk storage capacity is reached, potentially interrupting medical procedures.
Product
Philips Azurion System with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6. Models/Model Number: (1) Azurion 3M12: 722063, 722221; (2) Azurion 3M15: 722064, 722222; (3) Azurion SM12: 722227; (4) Azurion SM20: 722228; (5) Azurion 7B12/12: 722067, 722225…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1658-2023·2023-06-07
QUADROX-iD Pediatric Oxygenator Recalled Due to Packaging Sterile Barrier Defect
Maquet Medical Systems USA recalls 5,022 QUADROX-iD Pediatric Oxygenators distributed nationwide due to small pinholes in product packaging that may compromise the sterile barrier, potentially exposing patients to non-sterile devices.
Product
QUADROX-iD Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. BEQ-HMOD30000-USA 701070397 BEQ-HMOD30000-USA 701050330
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1646-2023·2023-06-07
Medline sterile surgical procedure packs recalled due to water damage
Medline Industries is recalling three sterile surgical procedure packs that were damaged by water, compromising their sterility. The recall affects 342 packs distributed in California.
Product
Procedure packs: (1) Medline Sterile Arthroscopy Pack, REF: DYNJ64242B; (2) Medline Sterile Shoulder Pack, REF: DYNJ64250A; and (3) Medline Sterile Upper Extremity Pack, REF: DYNJ64253B.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1645-2023·2023-06-07
EarlyVue VS30 Vital Signs Monitor Missing Calibration Alarm
Philips is recalling 1,421 EarlyVue VS30 Vital Signs Monitor units in the U.S. because a missing calibration alarm can cause inaccurate CO2 measurements and failure to detect critical patient condition changes.
Product
EarlyVue VS30 Vitals monitor with Software Versions A.00.02 and A.00.01 Product Number: 863380
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1661-2023·2023-06-07
Venous Hardshell Cardiotomy Reservoir packaging pinholes may compromise sterility
Maquet Medical Systems is recalling Venous Hardshell Cardiotomy Reservoirs because packaging pinholes may compromise the sterile barrier, potentially exposing patients to non-sterile devices that could cause infection or sepsis.
Product
Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model Item No. VKMO 10000-USA 701070441 VKMO 11000-USA 701070445
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1660-2023·2023-06-07
QUADROX-i Neonatal Oxygenator packaging may compromise sterile barrier
QUADROX-i Neonatal Oxygenators may have small pinholes in packaging that compromise the sterile barrier, potentially exposing the device to non-sterile conditions and risk of infection, sepsis, or ischemia.
Product
QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 10000-USA 701070412 HMO 11000-USA 701070416
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1672-2023·2023-06-07
Partial Knee Implant Recall Due to Higher-Than-Expected Revision Rates
Smith & Nephew is recalling 2,146 cementless partial knee implants (ENGAGE system) due to complaint data showing higher-than-expected revision rates compared to similar devices.
Product
Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Tray, Part Numbers: a) REF 1-10012-100, SIZE 1-LEFT MEDIAL; b) REF 1-10012-150, SIZE 1-RIGHT MEDIAL; c) REF 1-10012-200, SIZE 2-LEFT MEDIAL; d) REF 1-10012-250, SIZE 2-RIGHT MEDIAL; e) REF 1-10012-300…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1662-2023·2023-06-07
QUADROX-iR Heart-Lung Oxygenator Recalled for Sterile Barrier Packaging Defect
Maquet Medical is recalling QUADROX-iR oxygenators used in heart-lung bypass procedures due to potential pinholes in packaging that may compromise the sterile barrier, creating risk of serious infection.
Product
QUADROX-iR, used during cardiopulmonary bypass Model Item No. Description BEQ-HMO 51100-USA 701067936 Small Adult with filter, with BIOLINE coating BEQ-HMO 71100-USA 701067880 Adult with filter, with…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1655-2023·2023-06-07
QUADROX-i Pediatric Oxygenators Recalled for Packaging Sterility Defects
QUADROX-i Pediatric Oxygenators used in cardiopulmonary bypass surgery are recalled for packaging defects that may compromise sterility, potentially causing inflammation, infection, sepsis, or ischemia.
Product
QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 30000-USA 701070384 HMO 31000-USA 701070388
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1670-2023·2023-06-07
Smith & Nephew ENGAGE Cementless Knee System Recalled Over Revision Rate Concerns
Smith & Nephew has recalled 1,994 units of its ENGAGE Cementless Partial Knee System because recent data shows higher-than-expected revision rates compared to similar devices.
Product
Smith&Nephew ENGAGE Cementless Partial Knee System, Porous Femoral components, Part Numbers: a) REF 1-10003-100 (SIZE 1 Right Medial); b) REF 1-10003-110 (SIZE 1 Left Medial); c) REF 1-10003-200 (SIZE 2-Right Medial); d) REF 1-10003-210 (SIZE 2-Left Medial); e) REF…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1657-2023·2023-06-07
QUADROX-i Small Adult Oxygenator Recalled Due to Packaging Sterile Barrier Defect
Maquet Medical Systems USA is recalling 1,784 QUADROX-i Small Adult Oxygenators used in heart bypass surgery because product packaging may contain tiny pinholes that compromise sterile integrity, potentially allowing non-sterile exposure.
Product
QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model Item no. BEQ-HMO 50000-USA 701067905 HMO 50000-USA 701067891 HMO 51000-USA 701067895
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1653-2023·2023-06-07
Knee replacement implant bearing inserts mislabeled with wrong catalog numbers
Howmedica Osteonics recalled 24 TRIATHLON X3 tibial bearing inserts due to mislabeling, where units labeled with one catalog number may contain a different size. Medical facilities should discontinue use and contact the manufacturer.
Product
TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM-Intended for knee replacement Catalog Number: 5531-G-312-E
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1665-2023·2023-06-07
Elekta Medical Linear Accelerator Component Non-Compliant with Safety Standard
Elekta Inc. is recalling a limited number of Elekta Linacs due to a component non-compliant with safety standards. No reported injuries or illnesses.
Product
Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity; b. Versa HD; c. Elekta Synergy
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-1634-2023·2023-06-07
Cardiopulmonary bypass oxygenator recalled due to sterile barrier packaging defects
Maquet Medical Systems USA is recalling 8,670 HMOD 70000-USA/QUADROX-iD Adult oxygenators used in cardiopulmonary bypass due to packaging defects that may compromise sterile barriers and expose devices to contamination.
Product
HMOD 70000-USA/QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass Item no. 701067840
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1644-2023·2023-06-07
EarlyVue VS30 Vital Signs Monitor lacks calibration alarm, risking inaccurate CO2 readings
Philips EarlyVue VS30 vital signs monitors lack a calibration alarm, potentially causing inaccurate CO2 measurements. This could prevent clinicians from detecting changes in patient condition.
Product
EARLYVUE VS30 VITAL SIGNS MONITOR Software Version A.00.02 and A.00.01 Product Number: 863359
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1627-2023·2023-06-07
Medical X-Ray Imaging System Recalled for Device Malfunction
The CS 9600 X-ray imaging system manufactured by Trophy SAS has been recalled worldwide due to failure to function as intended and non-conformance to design specifications. Approximately 895 units are affected.
Product
CS¿9600¿is¿an¿extraoral¿system¿intended¿to¿produce¿two-dimensional¿and¿three-dimensional¿digital¿X-ray¿images¿of¿the¿dento-maxilofacial,¿ENT¿(Ear,¿Nose¿and¿Throat),¿cervical¿spine¿and¿wrist¿regions¿at¿the¿direction¿of¿healthcare¿professionals¿as¿diagnostic¿support¿for¿pediatric¿a…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1668-2023·2023-06-07
Medical Device Recall: X-Ray Detector Drive Shaft May Break
The FDA is recalling 32 X-ray detector units due to a potential drive shaft failure that could cause uncontrolled detector movement. Affected units are distributed in 10 US states.
Product
Intelli-C, Right side suspended Tabletop, REF: 03400000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1669-2023·2023-06-07
X-Ray Machine Detector May Move Unexpectedly Due to Drive Shaft Failure
FDA recalls the Intelli-C X-Ray machine's left side suspended tabletop model due to potential drive shaft failure in the detector lift mechanism, which could cause uncontrolled detector movement.
Product
Intelli-C, Left side suspended Tabletop, REF: 03400010
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1654-2023·2023-06-07
Knee Replacement Insert Mislabeled; Contents May Not Match Catalog Number
Howmedica Osteonics Corp. is recalling TRIATHLON X3 knee replacement bearing inserts because products labeled with one catalog number may actually contain a different specification. This mislabeling could result in incorrect implant sizing during surgery.
Product
TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM Intended for knee replacement Catalog Number: 5532-G-413-E
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1639-2023·2023-06-07
Maquet QUADROX-i Adult Oxygenator recalled for packaging damage compromising sterile barrier
Maquet Medical Systems is recalling QUADROX-i Adult Oxygenators due to potential packaging damage that may compromise sterile barriers, risking infection during cardiopulmonary bypass surgery.
Product
BEQ-HMO 71000-USA /QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Item no. 701067829
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1673-2023·2023-06-07
Smith & Nephew ENGAGE Knee System Recalled for Elevated Revision Risk
Smith & Nephew's ENGAGE Cementless Partial Knee System is being recalled due to higher-than-expected revision rates compared to similar devices. The recall affects 7,531 units distributed nationwide.
Product
Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Insert, Part Numbers: a) REF 1-10013-109, SIZE 1-LEFT MED, 9MM; b) REF 1-10013-110, SIZE 1-LEFT MED, 10MM; c) REF 1-10013-111, SIZE 1-LEFT MED, 11MM; d) REF 1-10013-113, SIZE 1-LEFT MED, 13MM; e) REF…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1640-2023·2023-06-07
QUADROX-i Neonatal oxygenator recalled for compromised sterile packaging
Maquet Medical Systems is recalling QUADROX-i Neonatal oxygenators due to packaging defects that may compromise sterility. Improper accessory placement and packaging damage could expose the device to contamination, risking infection and sepsis.
Product
QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 10000-USA 701070412 HMO 11000-USA 701070416
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1641-2023·2023-06-07
QUADROX-i Pediatric Oxygenator Packaging Defects Compromise Sterile Barrier
FDA Class II recall of QUADROX-i Pediatric oxygenators due to packaging defects—creases, holes, cracks—that compromise sterile barriers, risking infection and sepsis during cardiopulmonary bypass procedures.
Product
QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 30000-USA 701070384 HMO 31000-USA 701070388
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1642-2023·2023-06-07
Venous Hardshell Cardiotomy Reservoirs recalled for sterile packaging defects
Maquet Medical Systems USA is recalling Venous Hardshell Cardiotomy Reservoirs for cardiopulmonary bypass due to sterile packaging defects. Exposure to non-sterile product could result in infection, sepsis, or ischemia.
Product
Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model Item No. VKMO 10000-USA 701070441 VKMO 11000-USA 701070445
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1637-2023·2023-06-07
QUADROX-i Small Adult Oxygenator Recall Due to Sterile Packaging Defects
Maquet is recalling QUADROX-i Small Adult Oxygenators due to packaging defects that may compromise the sterile barrier. Exposure to non-sterile product could cause infection, sepsis, and ischemia.
Product
QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 50000-USA 701067891 HMO 51000-USA 701067895
Category
Medical Device
Distribution
Distributed nationwide

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10051–10075 of 39932