DrugDec 29, 2021
Medline Industries Hand Sanitizer Foam (ethyl alcohol), 62% v/v recall — FDA D-0287-2022
Defective Container: Customer complaints for leaking bottles and dispensing issues.
Class IIFDA: TerminatedMedline Industries Inc.
Recall history in this database
Classification mix: Class II: 133, Class III: 2, Class I: 2.
Medical DeviceOct 6, 2021
Medline Industries NAMIC Stopcocks: (1) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015002, UPN recall — FDA Z-2575-2021
Potential for sterile barrier breach. Microscopic pinholes within the sterile pouch could potentially lead to non-sterile conditions.
Class IIFDA: TerminatedMedline Industries Inc.
Medical DeviceOct 6, 2021
Medline Industries NAMIC Manifolds. (1) NAMIC Angiographic MANIFOLD, Medium Pressure, REF recall — FDA Z-2574-2021
Potential for sterile barrier breach. Microscopic pinholes within the sterile pouch could potentially lead to non-sterile conditions.
Class IIFDA: TerminatedMedline Industries Inc.
Medical DeviceJul 28, 2021
Medline Industries Cotton Rounds/Pads under the following brand names: 1 recall — FDA Z-2080-2021
Potential for mold contamination (Aspergillus vadensis)
Class IIFDA: TerminatedMedline Industries Inc.
DrugJun 16, 2021
READYPREP CHG, 2% Chlorhexidine Gluconate Cloth, 2 9x10.5 in (22.9x26.7 cm) Disposable recall — FDA D-0624-2021
Superpotent Drug: Product is above specification for active ingredient, 2% Chlorhexidine Gluconate.
Class IIIFDA: TerminatedMedline Industries Inc.
Medical DeviceJun 16, 2021
Medline Tissue Recovery Instrument Set, Reorder #DYNJ64347A, packaged 3/case, Sterile, Rx recall — FDA Z-1841-2021
The devices may not meet the minimum required sterility assurance level.
Class IIFDA: OngoingMedline Industries Inc.
Medical DeviceApr 21, 2021
Medline Industries Diluent, Stat-Site B-HB, 6x 3ML - Product Usage: Intended to be used with recall — FDA Z-1407-2021
Possible false negative or false positive results due to the product being compromised during shipment.
Class IIFDA: OngoingMedline Industries Inc.
Medical DeviceMar 24, 2021
Medline Industries RNA MEDICAL, QCHGB HEMOGLOBIN CONTROL, MULTI, REF QC HGB - Product Usage recall — FDA Z-1249-2021
Product was compromised during shipment.
Class IIFDA: TerminatedMedline Industries Inc.
Medical DeviceMar 3, 2021
Medline Industries S-O303000 CONTROL, STAT-SITE B-HB, 2X3ML,1LOW,1HIGH - Product Usage recall — FDA Z-1135-2021
Medline Industries, Inc. is removing specific lots of STAT-Site Controls (Low and High) S-O303000, from the market, due to the product being compromised during shipment.
Class IIIFDA: TerminatedMedline Industries Inc.
Medical DeviceJan 13, 2021
Medline Industries Greffe Aorte-LF recall — FDA Z-0782-2021
The cylindrical sponge component is not x-ray detectable.
Class IIFDA: TerminatedMedline Industries Inc.
Medical DeviceDec 23, 2020
Medline Industries RevMedX Trauma Dressings are packaged in a Tyvek Peel pouch, 1 Trauma recall — FDA Z-0615-2021
RevMedX Trauma Dressing is being recalled due to package seal integrity.
Class IIFDA: TerminatedMedline Industries Inc.
Medical DeviceOct 14, 2020
Medline Industries Kit Model #650301018, MTO Vascular Surgery - Cleveland Clinic PG recall — FDA Z-0062-2021
Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
Class IIFDA: TerminatedMedline Industries Inc.
Medical DeviceOct 14, 2020
Medline Industries Kit Model #65021652, MTO Left Heart Kit United Reg Health - Product recall — FDA Z-0061-2021
Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
Class IIFDA: TerminatedMedline Industries Inc.
Medical DeviceOct 14, 2020
Medline Industries Kit Model #650600111, MTO Left Heart St Francis Hosp - PG - Product recall — FDA Z-0066-2021
Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
Class IIFDA: TerminatedMedline Industries Inc.
Medical DeviceOct 14, 2020
Medline Industries Kit Model #65220955, MTO Left Heart Kit VA Med San Francisco - Product recall — FDA Z-0067-2021
Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
Class IIFDA: TerminatedMedline Industries Inc.
Medical DeviceOct 14, 2020
Medline Industries Kit Model #650304917, MTO Protection Station Plus with Drape - Product recall — FDA Z-0064-2021
Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
Class IIFDA: TerminatedMedline Industries Inc.
Medical DeviceOct 14, 2020
Medline Industries Kit Model #650301023, MTO Radiology Kit Cleveland Clinic - Product Usage recall — FDA Z-0063-2021
Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
Class IIFDA: TerminatedMedline Industries Inc.
Medical DeviceOct 14, 2020
Medline Industries ClearPro Closed Suction Catheter, Model DYNCPDS14T, 14 Fr FOR recall — FDA Z-0058-2021
There have been reports of the suction catheter coming apart from the device assembly during use.
Class IIFDA: TerminatedMedline Industries Inc.
Medical DeviceOct 14, 2020
Medline Industries Kit Model #650305414, MTO Left Heart with DT Boulder Com Hosp - Product recall — FDA Z-0065-2021
Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
Class IIFDA: TerminatedMedline Industries Inc.
Medical DeviceOct 14, 2020
Medline Industries Kit Model #65193091, MTO Left Heart Kit - Product Usage: NAMIC Cath Lab recall — FDA Z-0068-2021
Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
Class IIFDA: TerminatedMedline Industries Inc.
Medical DeviceAug 12, 2020
Medline Industries Endoscopic Cleaning Brush - Product Usage: Endoscopic cleaning brushes recall — FDA Z-2766-2020
Potential risk of brush detachment during cleaning.
Class IIFDA: TerminatedMedline Industries Inc.
Medical DeviceAug 5, 2020
Medline Industries ClearPro Trach T-Piece Closed Suction Catheter, Model DYNCPTP14T, 14 Fr recall — FDA Z-2725-2020
There are reports of the suction catheter coming apart from the device assembly during use.
Class IIFDA: OngoingMedline Industries Inc.
Medical DeviceAug 5, 2020
Medline Industries ClearPro T-Piece Closed Suction Catheter, Model DYNCPTP14, 14 Fr 21.3 IN recall — FDA Z-2724-2020
There are reports of the suction catheter coming apart from the device assembly during use.
Class IIFDA: OngoingMedline Industries Inc.
Medical DeviceMay 27, 2020
Medline Industries SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 8 Fr 3 ml - Product recall — FDA Z-2043-2020
Loose silicone particulate was found to be present on the shaft of the silicone catheters.
Class IIFDA: TerminatedMedline Industries Inc.
Understanding this recall history
This page summarizes recall records in which the official source identifies Medline Industries, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.