Medical DeviceFeb 17, 2021
ICU Medical 60 IN (152cm) APPX 1.5 ml, PUR YELLOW SMALLBORE SET, FILTER REF B2209 - Product recall — FDA Z-0955-2021
Due to the incorrect filter assembly.
Class IIFDA: TerminatedICU Medical, Inc.
Latest records
Latest recalls — page 902
The newest recall records with useful source details are listed here.
Medical DeviceFeb 17, 2021
Aomori Olympus Co INJECTOR FORCEMAX UP 2.8MMCH 25G 5MM, model no recall — FDA Z-0997-2021
Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
Class IIFDA: TerminatedAomori Olympus Co., Ltd.
Medical DeviceFeb 17, 2021
Aomori Olympus Co B-V243Q-A 3-LUMEN EXTRACTION BALLOON V, model no recall — FDA Z-0967-2021
Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
Class IIFDA: TerminatedAomori Olympus Co., Ltd.
Medical DeviceFeb 17, 2021
Aomori Olympus Co INJECTOR FORCEMAX UP 2MM CH 23G 6MM, model no recall — FDA Z-1028-2021
Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
Class IIFDA: TerminatedAomori Olympus Co., Ltd.
Medical DeviceFeb 17, 2021
Cardinal Health 200 Gown Kendall Blue XXL, SKU CT5102 Cardinal Health Isolation Gown, Lab recall — FDA Z-1097-2021
There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats.
Class IIFDA: OngoingCardinal Health 200, LLC
Medical DeviceFeb 17, 2021
Aomori Olympus Co NEEDLEMASTER 4MMx 23G LOWER, model no recall — FDA Z-1042-2021
Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
Class IIFDA: TerminatedAomori Olympus Co., Ltd.
Medical DeviceFeb 17, 2021
Aomori Olympus Co INJECTOR FORCEMAX UP 2MM CH 25G 4MM, model no recall — FDA Z-1025-2021
Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
Class IIFDA: TerminatedAomori Olympus Co., Ltd.
Medical DeviceFeb 17, 2021
Aomori Olympus Co NEEDLEMASTER 6MMx 25G UPPER, model no recall — FDA Z-1039-2021
Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
Class IIFDA: TerminatedAomori Olympus Co., Ltd.
Medical DeviceFeb 17, 2021
Aomori Olympus Co INJECTOR FORCEMAX UP 2.8MMCH 23G 5MM, model no recall — FDA Z-1011-2021
Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
Class IIFDA: TerminatedAomori Olympus Co., Ltd.
Medical DeviceFeb 17, 2021
Aomori Olympus Co NEEDLEMASTER 1.8MMx 26G LOWER, model no recall — FDA Z-1049-2021
Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
Class IIFDA: TerminatedAomori Olympus Co., Ltd.
Medical DeviceFeb 17, 2021
Aomori Olympus Co NEEDLEMASTER 6MMx 21G UPPER, model no recall — FDA Z-1037-2021
Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
Class IIFDA: TerminatedAomori Olympus Co., Ltd.
Medical DeviceFeb 17, 2021
Aomori Olympus Co SD-400U-10 SNAREMASTER PLUS Hot/Cold 10m, model no recall — FDA Z-0991-2021
Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
Class IIFDA: TerminatedAomori Olympus Co., Ltd.
Medical DeviceFeb 17, 2021
Aomori Olympus Co INJECTOR FORCEMAX LOWER 23G 5MM, model no recall — FDA Z-1019-2021
Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
Class IIFDA: TerminatedAomori Olympus Co., Ltd.
Medical DeviceFeb 17, 2021
Aomori Olympus Co NEEDLEMASTER 4MMx 26G LOWER, model no recall — FDA Z-1044-2021
Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
Class IIFDA: TerminatedAomori Olympus Co., Ltd.
Medical DeviceFeb 17, 2021
Aomori Olympus Co B7-2C BALLOON CATHETER 13mm dia 2.8 recall — FDA Z-0963-2021
Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
Class IIFDA: TerminatedAomori Olympus Co., Ltd.
Medical DeviceFeb 17, 2021
Aomori Olympus Co NEEDLEMASTER 6MMx 25G LOWER, model no recall — FDA Z-1048-2021
Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
Class IIFDA: TerminatedAomori Olympus Co., Ltd.
Medical DeviceFeb 17, 2021
Aomori Olympus Co KD-612L ELECTROSURGICAL KNIFE, model no recall — FDA Z-0975-2021
Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
Class IIFDA: TerminatedAomori Olympus Co., Ltd.
Medical DeviceFeb 17, 2021
Aomori Olympus Co NEEDLEMASTER 6MMx 23G UPPER, model no recall — FDA Z-1038-2021
Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
Class IIFDA: TerminatedAomori Olympus Co., Ltd.
Medical DeviceFeb 17, 2021
Aomori Olympus Co KD-612U ELECTROSURGICAL SNARE, model no recall — FDA Z-0976-2021
Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
Class IIFDA: TerminatedAomori Olympus Co., Ltd.
Medical DeviceFeb 17, 2021
Cardinal Health 200 Lab Coats SMS 2X-Large Blue, SKU 2204LC Cardinal Health Isolation Gown recall — FDA Z-1091-2021
There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats.
Class IIFDA: OngoingCardinal Health 200, LLC
Medical DeviceFeb 17, 2021
Aomori Olympus Co INJECTOR FORCEMAX UP 2MM CH 25G 6MM, model no recall — FDA Z-1029-2021
Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
Class IIFDA: TerminatedAomori Olympus Co., Ltd.
Medical DeviceFeb 17, 2021
Aomori Olympus Co NEEDLEMASTER 4MMx 21G UPPER, model no recall — FDA Z-1030-2021
Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
Class IIFDA: TerminatedAomori Olympus Co., Ltd.
Medical DeviceFeb 17, 2021
Aomori Olympus Co NEEDLEMASTER 4MMx 25G UPPER, model no recall — FDA Z-1032-2021
Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
Class IIFDA: TerminatedAomori Olympus Co., Ltd.
Medical DeviceFeb 17, 2021
Aomori Olympus Co KD-650U ELECTROSURGICAL SNARE, model no recall — FDA Z-0981-2021
Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
Class IIFDA: TerminatedAomori Olympus Co., Ltd.
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Recent recall archives
Browse recent months with enough recall history for useful comparison.
October 2026111 records · 4 categoriesSeptember 2026364 records · 4 categoriesAugust 2026302 records · 4 categoriesJuly 2026370 records · 4 categoriesJune 2026376 records · 4 categoriesMay 2026340 records · 4 categoriesApril 2026415 records · 4 categoriesMarch 2026190 records · 4 categoriesFebruary 2026331 records · 4 categoriesJanuary 2026212 records · 4 categoriesDecember 2025389 records · 4 categoriesNovember 2025326 records · 4 categories