All Recalls

95,018 total recalls in our database

Product may be contaminated with mold.

Jul 15, 2024 Dairy & Eggs View Details →

Failed Impurities/Degradation Specifications: Out-of-specification results obtained for related impurities and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.

Aug 7, 2024 Prescription Drugs View Details →

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Jun 11, 2024 Surgical Instruments Nationwide View Details →

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Jun 11, 2024 Surgical Instruments Nationwide View Details →

Invalid Controls. The Low Control is out of range; too high which causes invalid runs that would result in repeating the runs and delays for reporting results to patients.

Jul 5, 2024 Diagnostic Equipment Nationwide View Details →

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K22C (Vein Tray Angiography kit), REF: K09T-11796F K12T-01558G K12T-01558H K12T-01822 K12T-01852L K12T-02006J K12T-02054 K12T-02091G K12T-02102B K12T-02309 K12T-02392A K12T-02416 K12T-02510N K12T-02725G K12T-02725H K12T-02890K K12T-02949A K12T-03012C K12T-03014B K12T-03058A K12T-03139 K12T-03203F K12T-03319 K12T-03321F K12T-03515 K12T-03560D K12T-03566H K12T-03638H K12T-03706A K12T-03746C K12T-03788 K12T-03839H K12T-03853C K12T-03866B K12T-03867A K12T-03868 K12T-03868A K12T-04068 K12T-04106D K12T-04106F K12T-04140J K12T-04586D K12T-04697 K12T-04959B K12T-04963A K12T-05061J K12T-05081D K12T-05093D K12T-05281C K12T-05334D K12T-05423G K12T-05442B K12T-05472H K12T-05559B K12T-05824G K12T-05824H K12T-05825H K12T-05926C K12T-05991A K12T-06033C K12T-06211B K12T-06250 K12T-06282 K12T-06374D K12T-06416A K12T-06561A K12T-06640C K12T-06732A K12T-06783B K12T-06819C K12T-06979B K12T-07003A K12T-07008G K12T-07088 K12T-07266A K12T-07305 K12T-07556C K12T-07614A K12T-07729A K12T-07845B K12T-07893B K12T-08003 K12T-08565A K12T-08614B K12T-08727B K12T-08801 K12T-08867 K12T-09267D K12T-09337A K12T-09438A K12T-09523A K12T-09595 K12T-09685 K12T-09875 K12T-09880A K12T-09889 K12T-09974A K12T-10167A K12T-10287 K12T-10338H K12T-10409 K12T-10733 K12T-11467 K12T-11524A K12T-12152A K12T-12456 K22C-00001 K22C-00001A K22C-00034 K22C-00035 K22C-00042 K22C-00043 K22C-00052 K22C-00053A K22C-00054A K22C-00056 K22C-00058A K22C-00059 K22C-00062A K22C-00064A K22C-00069 K22C-00069A K22C-00070 K22C-11010 To support various vascular or cardiac diagnostic and interventional procedures.

Merit Medical Systems

🏥 Medical Devices Class I - Dangerous

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Jun 11, 2024 Diagnostic Equipment Nationwide View Details →

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Jun 11, 2024 Diagnostic Equipment Nationwide View Details →

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K09/K09T (Custom Manifold Kit), REF: K09-00526L K09-00807AH K09-01467AD K09-01467AF K09-01514U K09-01734L K09-02040C K09-02683F K09-02804B K09-03844F K09-04088H K09-04088J K09-04863J K09-04946B K09-04998H K09-04998HP K09-05229JP K09-05342A K09-05375F K09-05939D K09-07759J K09-07789L K09-07789M K09-07828U K09-07828UP K09-07834C K09-07905G K09-08031D K09-08052Q K09-08065J K09-08150R K09-08423G K09-08493KP K09-08847A K09-08875B K09-09051H K09-09184B K09-09403HP K09-09481A K09-09499B K09-09814 K09-09900F K09-09902G K09-09902GP K09-09975 K09-10060F K09-10062F K09-10210A K09-10210B K09-10286G K09-10300F K09-10315B K09-10432A K09-10444J K09-10475 K09-10494C K09-10574D K09-10726 K09-10736D K09-10788A K09-10811 K09-10829B K09-10830C K09-10929 K09-10994D K09-11024DP K09-11076C K09-11107D K09-11149B K09-11196 K09-11207DP K09-11259G K09-11259GP K09-11444B K09-11482D K09-11607B K09-11646C K09-11913C K09-12030AP K09-12245A K09-12304A K09-12304B K09-12359B K09-12396FP K09-12404 K09-12556B K09-12615 K09-12698 K09-12698A K09-12699 K09-12699A K09-12699B K09-12704A K09-12867A K09-12899A K09-12939B K09-12939C K09-13082C K09-13171 K09-13228A K09-13337BP K09-13420 K09-13507CP K09-13617P K09-13659AP K09-13660 K09-13767 K09-13880 K09-13882 K09-13882A K09-13933 K09-14000 K09-14000A K09-14047 K09-14096 K09-14196 K09-14219 K09-14220 K09T-13643 To support fluid administration into the body. To support various vascular or cardiac diagnostic and interventional procedures.

Merit Medical Systems

🏥 Medical Devices Class I - Dangerous

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Jun 11, 2024 Diagnostic Equipment Nationwide View Details →
🏥 Medical Devices Class I - Dangerous

Specimen collection device may leak after the patient sample swabs have been inserted into the test tubes, which could result in biohazard exposure, cross contamination causing false positive results for other specimens, and/or delay to test results.

Jun 20, 2024 Other Medical Devices Nationwide View Details →
🏥 Medical Devices Class I - Dangerous

Beckman Coulter, Inc. has identified a rise in reagent carousel motion errors in Access 2 Immunoassay System Analyzers that appear to be caused by misaligned index wheels housed within the reagent carousel module. Customers affected by this issue may observe an increase in reagent carousel motion errors or QSMC errors that occur while unloading or loading reagent packs during system initialization and sample processing, which causes a non-operational system status and cancels tests; and patient results may be delayed if these errors cancel test processing.

Jun 14, 2024 Other Medical Devices Nationwide View Details →

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Jun 11, 2024 Surgical Instruments Nationwide View Details →

Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expected.

May 7, 2024 Infusion Pumps Nationwide View Details →
🏥 Medical Devices Class I - Dangerous

Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, which may cause device reset, which may lead to transient loss of stimulation; patients may experience undesired sensations when therapy turns off for approx. 10-15 seconds and then back on, which may lead patient to request surgical intervention for replacement or revision.

Jul 17, 2024 Other Medical Devices Nationwide View Details →

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Jun 11, 2024 Diagnostic Equipment Nationwide View Details →

It was noticed in production on 28.10.2021, that the final testing database gives a pass result for Pan ADC repeatability test even when the test result is not within the set acceptance criteria (repeatability within 4%).

Oct 28, 2021 Other Medical Devices Nationwide View Details →

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Jun 11, 2024 Diagnostic Equipment Nationwide View Details →

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Customer Procedure Kit (Angiography/Angioplasty kit), REF: K09T-01138 K09T-04484A K09T-04757F K09T-04835H K09T-07256D K09T-07588B K09T-07611K K09T-07649K K09T-07649L K09T-07649M K09T-09035H K09T-09035J K09T-09035M K09T-09035N K09T-09107K K09T-09319C K09T-09599Q K09T-09672H K09T-09672J K09T-09843AP K09T-10192B K09T-10405A K09T-10449 K09T-10542G K09T-10790D K09T-10899C K09T-11052F K09T-11266B K09T-11305F K09T-11372G K09T-11496A K09T-11541B K09T-11831C K09T-11940A K09T-11940B K09T-12050D K09T-12292B K09T-12558D K09T-12624B K09T-13050F K09T-13097B K09T-13097C K09T-13232 K09T-13257 K09T-13335B K09T-13362A K09T-13362B K09T-13468A K09T-13469A K09T-13521C K09T-13595A K09T-13666 K09T-13801 K09T-14072A K09T-14106 K10T-03350C K10T-04039F K10T-04245G K10T-04385G K10T-04448M K10T-04486D K10T-04486F K10T-04741 K10T-04845G K10T-05008B K10T-05199B K10T-05342D K10T-05468F K10T-05581B K10T-05602A K10T-05745B K10T-05991A K10T-06073 K12T-01749D K12T-02061A K12T-02061B K12T-02162B K12T-02460F K12T-03044G K12T-03327G K12T-03723C K12T-03975B K12T-04229H K12T-04312T K12T-04323G K12T-04324D K12T-04849C K12T-04997F K12T-05302H K12T-05302J K12T-05396D K12T-05519C K12T-05524F K12T-05674D K12T-05741 K12T-05741A K12T-06472 K12T-06693C K12T-06823D K12T-06823F K12T-06899 K12T-07098 K12T-07204A K12T-07351C K12T-07543F K12T-07543G K12T-07545B K12T-07703A K12T-07822F K12T-07918C K12T-08368B K12T-08769B K12T-08980 K12T-09026A K12T-09129H K12T-09195A K12T-09350 K12T-09354 K12T-09526B K12T-09586 K12T-09722 K12T-09890A K12T-09922C K12T-10006 K12T-10006A K12T-10006B K12T-10006C K12T-10024 K12T-10092A K12T-10121A K12T-10235A K12T-10262A K12T-10293D K12T-10311 K12T-10316A K12T-10489B K12T-10489C K12T-10584A K12T-10653 K12T-10660D K12T-10778C K12T-10978A K12T-10996B K12T-11004A K12T-11069 K12T-11091 K12T-11098B K12T-11116B K12T-11124 K12T-11229A K12T-11326A K12T-11405B K12T-11471B K12T-11514A K12T-11615A K12T-11626A K12T-11672 K12T-11759 K12T-12078 K12T-12078B K12T-12200A K12T-12275 K12T-12276 K12T-12278 K12T-12405 K12T-12466 K12T-12499 K17T-00008 K17T-00010B K17T-00013 To support fluid administration into the body and physiological pressure monitoring. To support various vascular or cardiac diagnostic and interventional procedures

Merit Medical Systems

🏥 Medical Devices Class I - Dangerous

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Jun 11, 2024 Diagnostic Equipment Nationwide View Details →