Medline Industries Inc
Complete recall history across all FDA and CPSC categories — 160 total recalls
Recall Summary
Medline Industries Inc appears in recall records across 2 categories. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Drug Recalls (75)
FDA drug safety enforcement actions by Medline Industries Inc. Showing most recent 50.
| Date | Product | Reason | Class |
|---|---|---|---|
| Nov 8, 2021 | Hand Sanitizer Foam (ethyl alcohol), 62% v/v, packaged in a) 1.5 Oz. cans, ND... | Defective Container: Customer complaints for leaking bottles and dispensing i... | Class II |
| May 14, 2021 | READYPREP CHG, 2% Chlorhexidine Gluconate Cloth, 2 9x10.5 in (22.9x26.7 cm) D... | Superpotent Drug: Product is above specification for active ingredient, 2% Ch... | Class III |
| Sep 17, 2018 | SparkleFresh Fluoride Toothpaste, Sodium Monofluorophosphate 0.76%, a) 17 g t... | Microbial Contamination of Non-Sterile Product | Class II |
| Feb 15, 2018 | PVP Scrub Solution, Povidone Iodine, 7.5% (equivalent to 0.75% available iodi... | Subpotent Drug: product not meeting the iodine assay level requirements throu... | Class II |
| Sep 21, 2017 | Medline All Purpose Instrument Tray, Sterile. Packaged in Mexico for Medline ... | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pa... | Class II |
| Sep 21, 2017 | Liberator Medical Supply Catheter Insertion Tray, Sterile, Single Use Only. D... | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pa... | Class II |
| Sep 21, 2017 | Professional Hospital Supply Suture Removal Kit, Sterile, Single Use Only. Pa... | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pa... | Class II |
| Sep 21, 2017 | Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico by ... | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pa... | Class II |
| Sep 21, 2017 | Medline Straight Suture Removal Tray, Sterile, Single Use Only. Packaged in M... | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pa... | Class II |
| Sep 21, 2017 | Medline GHS Suture Removal Tray, Sterile, Single Use Only. Packaged in USA fo... | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pa... | Class II |
| Sep 21, 2017 | Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for M... | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pa... | Class II |
| Sep 21, 2017 | Medline Incision Drainage Kit, Sterile, Single Use Only. Packaged in Mexico b... | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pa... | Class II |
| Sep 21, 2017 | Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Me... | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pa... | Class II |
| Sep 21, 2017 | Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico by ... | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pa... | Class II |
| Sep 21, 2017 | Medline General Purpose Tray, Sterile, Single Use Only. Packaged in USA for M... | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pa... | Class II |
| Sep 21, 2017 | Medline NICC Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexic... | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pa... | Class II |
| Sep 21, 2017 | Medline Skin Staple Remover Kit, Sterile, Single Use Only. Packaged in Mexico... | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pa... | Class II |
| Sep 21, 2017 | Medline Skin Biopsy Pack-LF, Sterile, Single Use Only. Packaged in USA by Med... | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pa... | Class II |
| Sep 21, 2017 | Medical Equipment Affiliates IV Start Kit, Sterile, Single Use Only. Packaged... | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pa... | Class II |
| Sep 21, 2017 | Medline General Purpose Tray, Sterile, Single Use Only. Packaged in USA for M... | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pa... | Class II |
| Sep 21, 2017 | Medline Laceration Tray, Sterile, Single Use Only. Packaged in USA for Medlin... | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pa... | Class II |
| Sep 21, 2017 | Medline Anesthesia Kit, Single Use Only. Packaged in Mexico by Medline Indust... | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pa... | Class II |
| Sep 21, 2017 | Medline Pacemaker Implant Pack, Sterile, Single Use Only. Packaged in Mexico ... | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pa... | Class II |
| Sep 21, 2017 | Medline Incision & Drainage Tray, Sterile, Single Use Only. Packaged in USA f... | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pa... | Class II |
| Sep 21, 2017 | Medline Staple Remover Kit, Sterile, Single Use Only. Packaged in USA for Med... | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pa... | Class II |
| Sep 21, 2017 | Medline Suture Removal Kit, Sterile, Single Use Only. Packaged in Mexico for ... | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pa... | Class II |
| Sep 21, 2017 | Medline Incision and Drainage Tray, Sterile, Single Use Only. Packaged in Mex... | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pa... | Class II |
| Sep 21, 2017 | Medline Staple Remover Tray, Sterile, Single Use Only. Packaged in USA for Me... | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pa... | Class II |
| Sep 21, 2017 | Medline CNTRL Line Removal Kit Scripps. Packaged in USA for Medline Industrie... | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pa... | Class II |
| Sep 21, 2017 | Medline CC Drawer 4 IV Circulation Pack, Contains Rx, Single Use Only, contai... | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pa... | Class II |
| Sep 21, 2017 | Medline Catheter Insertion Kit, Sterile. Packaged in Mexico for Medline Indus... | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pa... | Class II |
| Sep 21, 2017 | Medline Circumcision Tray Kit, Sterile, Single use only. Packaged in Mexico f... | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pa... | Class II |
| Sep 21, 2017 | Medline Sheath Removal Kit, Sterile, Single use only. Packaged in Mexico for ... | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pa... | Class II |
| Sep 21, 2017 | Medline Trunk Kit, Non-sterile. Packaged in USA for Medline Industries, Inc.,... | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pa... | Class II |
| Sep 21, 2017 | Medline Suture Removal Pack Latex Safe, Sterile, Single Use Only. Packaged in... | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pa... | Class II |
| Sep 21, 2017 | Medline I&D Tray Kit, Sterile, Single use only. Packaged in Mexico for Medlin... | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pa... | Class II |
| Sep 21, 2017 | Medline DC Line Kit, Sterile, Single use only. Packaged in Mexico for Medline... | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pa... | Class II |
| Sep 21, 2017 | Medline Incision and Drainage Tray, Sterile, Single Use Only. Packaged in Mex... | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pa... | Class II |
| Sep 21, 2017 | Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico for... | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pa... | Class II |
| Sep 21, 2017 | Medline Hip Replacement, Kit, Sterile, Single Use Only. Packaged in Mexico by... | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pa... | Class II |
| Sep 21, 2017 | Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico by ... | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pa... | Class II |
| Sep 21, 2017 | Medline IV Start Kit, Sterile, Single use only. Packaged in Mexico for Medlin... | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pa... | Class II |
| Sep 21, 2017 | Medline Skin Stapler RMVR, Tray Sterile, Single Use Only. Packaged in Mexico... | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pa... | Class II |
| Sep 21, 2017 | Medline Wound Closure Tray, Sterile, Single use only. Packaged in Mexico for ... | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pa... | Class II |
| Sep 21, 2017 | Medline TRAY, CATHETER CARE, LIDDED. Packaged in USA for Medline Industries, ... | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pa... | Class II |
| Sep 21, 2017 | Medline Irrigation W/Piston SYR Tray, Sterile, Single Use Only. Packaged in M... | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pa... | Class II |
| Sep 21, 2017 | Medline Concordia Nurse Bag Kit. Packaged in USA for Medline Industries, Inc.... | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pa... | Class II |
| Sep 21, 2017 | Medline INCISION AND DRAINAGE TRAY Kit, Sterile, Single use only. Packaged in... | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pa... | Class II |
| Sep 21, 2017 | Medline Debridement Tray, Sterile, Single Use Only. Assembled in USA by Medli... | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pa... | Class II |
| Sep 21, 2017 | Professional Hospital Supply Suture Removal Kit, Sterile, Single Use Only. Pa... | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pa... | Class II |
Device Recalls (85)
FDA medical device enforcement actions by Medline Industries Inc. Showing most recent 50.
| Date | Product | Reason | Class |
|---|---|---|---|
| Oct 27, 2021 | Neuro Convenience Kit | NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 0... | Class II |
| Oct 27, 2021 | Bedside PICC CDS Convenience Kit | NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 0... | Class II |
| Oct 27, 2021 | Major Vascular CDS Convenience Kit | NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 0... | Class II |
| Oct 27, 2021 | Venous Access Pack-LF Convenience Kit | NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 0... | Class II |
| Oct 27, 2021 | EVLP Convenience Pack/Kit | NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 0... | Class II |
| Aug 6, 2021 | NAMIC Manifolds. (1) NAMIC Angiographic MANIFOLD, Medium Pressure, REF ... | Potential for sterile barrier breach. Microscopic pinholes within the steril... | Class II |
| Aug 6, 2021 | NAMIC Stopcocks: (1) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015002, UPN H... | Potential for sterile barrier breach. Microscopic pinholes within the steril... | Class II |
| Jul 1, 2021 | Medline Shoulder CDS convenience kits, REF DYNJ902837D and REF DYNJ902837F, c... | The kits may contain an expired component. | Class II |
| Jul 1, 2021 | Medline Total Knee, convenience kit, REF DYNJ907129B, containing expired com... | The kits may contain an expired component. | Class II |
| Jul 1, 2021 | Medline Knee Arthroscopy Kit, convenience kit, REF DYNJ902838C, containing e... | The kits may contain an expired component. | Class II |
| Jul 1, 2021 | Medline Arthroscopy Kit, convenience kit, REF DYNJ904304B, containing expire... | The kits may contain an expired component. | Class II |
| May 25, 2021 | Cotton Rounds/Pads under the following brand names: 1. BEAUTY 360 Extra Lar... | Potential for mold contamination (Aspergillus vadensis) | Class II |
| Apr 30, 2021 | Medline Tissue Recovery Instrument Set, Reorder #DYNJ64347A, packaged 3/case,... | The devices may not meet the minimum required sterility assurance level. | Class II |
| Mar 15, 2021 | Diluent, Stat-Site B-HB, 6x 3ML - Product Usage: Intended to be used with the... | Possible false negative or false positive results due to the product being co... | Class II |
| Jan 25, 2021 | RNA MEDICAL, QCHGB HEMOGLOBIN CONTROL, MULTI, REF QC HGB - Product Usage: mon... | Product was compromised during shipment. | Class II |
| Jan 15, 2021 | S-O303000 CONTROL, STAT-SITE B-HB, 2X3ML,1LOW,1HIGH - Product Usage: intended... | Medline Industries, Inc. is removing specific lots of STAT-Site¿ Controls (Lo... | Class III |
| Nov 13, 2020 | Simple Neck Dissection, Model DYNJ47481C - Product Usage: This is a type of c... | The cylindrical sponge component is not x-ray detectable. | Class II |
| Nov 13, 2020 | Thyroid Pack CKHA-LF, Model DYNJ50352B - Product Usage: This is a type of con... | The cylindrical sponge component is not x-ray detectable. | Class II |
| Nov 13, 2020 | Greffe Aorte-LF (product info is in French); Model DYNJ31877F - Product Usage... | The cylindrical sponge component is not x-ray detectable. | Class II |
| Nov 13, 2020 | Cardiac Pack - LF, Model DYNJ31903I - Product Usage: This is a type of conven... | The cylindrical sponge component is not x-ray detectable. | Class II |
| Nov 13, 2020 | Resect. Intest. Laparo-LF, Model DYNJ42667A - Product Usage: This is a type o... | The cylindrical sponge component is not x-ray detectable. | Class II |
| Nov 5, 2020 | RevMedX Trauma Dressings are packaged in a Tyvek Peel pouch, 1 Trauma Dressin... | RevMedX Trauma Dressing is being recalled due to package seal integrity. | Class II |
| Oct 1, 2020 | The Quidel Triage BNP Calibrators | Product compromised during shipment. | Class II |
| Sep 15, 2020 | Quick Release Gait Belt, 60 | The buckle on the Gait Belt may break due to degradation of the material due ... | Class II |
| Sep 14, 2020 | Kit Model #65193091, MTO Left Heart Kit - Product Usage: NAMIC Cath Lab and I... | Non-sterile kits intended to be sterilized prior to use were sold to accounts... | Class II |
| Sep 14, 2020 | Kit Model #650305414, MTO Left Heart with DT Boulder Com Hosp - Product Usage... | Non-sterile kits intended to be sterilized prior to use were sold to accounts... | Class II |
| Sep 14, 2020 | Kit Model #650301023, MTO Radiology Kit Cleveland Clinic - Product Usage: NAM... | Non-sterile kits intended to be sterilized prior to use were sold to accounts... | Class II |
| Sep 14, 2020 | Kit Model #650304917, MTO Protection Station Plus with Drape - Product Usage:... | Non-sterile kits intended to be sterilized prior to use were sold to accounts... | Class II |
| Sep 14, 2020 | Kit Model #65220955, MTO Left Heart Kit VA Med San Francisco - Product Usage:... | Non-sterile kits intended to be sterilized prior to use were sold to accounts... | Class II |
| Sep 14, 2020 | Kit Model #650600111, MTO Left Heart St Francis Hosp - PG - Product Usage: NA... | Non-sterile kits intended to be sterilized prior to use were sold to accounts... | Class II |
| Sep 14, 2020 | Kit Model #65021652, MTO Left Heart Kit United Reg Health - Product Usage: NA... | Non-sterile kits intended to be sterilized prior to use were sold to accounts... | Class II |
| Sep 14, 2020 | Kit Model #650301018, MTO Vascular Surgery - Cleveland Clinic PG - Product Us... | Non-sterile kits intended to be sterilized prior to use were sold to accounts... | Class II |
| Sep 1, 2020 | ClearPro Closed Suction Catheter, Model DYNCPDS14T, 14 Fr FOR ENDOTRACHEAL T... | There have been reports of the suction catheter coming apart from the device ... | Class II |
| Aug 12, 2020 | Central Line Dressing Change Tray | Potential of incomplete seals impacting the sterility of the kit. | Class II |
| Jul 28, 2020 | Control, Calibrator Verified, Triage BNP, Model ALR88755 | Product was shipped with refrigeration (ice) instead of frozen (dry ice). | Class II |
| Jul 9, 2020 | Endoscopic Cleaning Brush - Product Usage: Endoscopic cleaning brushes are si... | Potential risk of brush detachment during cleaning. | Class II |
| Jun 30, 2020 | ClearPro T-Piece Closed Suction Catheter, Model DYNCPTP14, 14 Fr 21.3 IN FOR ... | There are reports of the suction catheter coming apart from the device assemb... | Class II |
| Jun 30, 2020 | ClearPro Trach T-Piece Closed Suction Catheter, Model DYNCPTP14T, 14 Fr 12.5 ... | There are reports of the suction catheter coming apart from the device assemb... | Class II |
| Mar 9, 2020 | Custom convenience kits containing Medline brand Sterile Pre-Saturated Povido... | Medline identified that there may be a potential for voids in the packaging s... | Class II |
| Feb 10, 2020 | Medline Winged Sponges Presaturated W/PVP REF DYND70289 DYND70289H Expiration... | Voids were discovered in the packaging seal and loss of sterility on the outs... | Class II |
| Feb 10, 2020 | Medline Sterile 3mL Syringes with 21GA x 1 Inch Needle 80 each REF DYND3ML21G... | Voids were discovered in the packaging seal and loss of sterility on the outs... | Class II |
| Feb 10, 2020 | Medline Stick Sponge Presaturated W/PVP REF DYND70288 DYND70288H 2/PK Expirat... | Voids were discovered in the packaging seal and loss of sterility on the outs... | Class II |
| Jan 21, 2020 | Medline HOI LUMBAR REF DYNJ902823G Lot 20AKA895 Expiration 2021-05-31 1 e... | The sterile pack inside the Complete Delivery System (CDS) did not go through... | Class II |
| Jan 21, 2020 | Medline ROBOTIC-LF REF CDS984543B Lot 20AKA927 Expiration 2020-09-30 GTI... | The sterile pack inside the Complete Delivery System (CDS) did not go through... | Class II |
| Jan 7, 2020 | Medline DYNDA1928 VP TRAY WITH PVP Packaged in Mexico GLOVE:Made in Malays... | There is potential for the sterile wrap to become loose while in transit and ... | Class II |
| Oct 30, 2019 | Anesthesia Pediatric Circuit 72", Model DYNJAPF6057A | The 10mm inner green inspiratory tubing is disconnected from the tee connecto... | Class II |
| Sep 18, 2019 | EVENCARE G3 Blood Glucose Test Strips, 1 test strip per foil pouch, 50 foil p... | Incomplete seal and premature expiration of individually packaged Blood Gluco... | Class II |
| Sep 6, 2019 | MEDLINE ELECTRIC SURGICAL CLIPPER AND BASE, REF DYND70800 Product Usage: ... | The recall is being conducted due to a potential defective component on the c... | Class II |
| Aug 9, 2019 | Medline SYRINGE, PISTON,IRR TRAY,W/.9, REF DYNC2303. Sterile Piston Irrigati... | Samples in the identified lot were found to have incomplete or open packaging... | Class II |
| May 28, 2019 | SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 10 Fr 3 ml - Product Usage... | Loose silicone particulate was found to be present on the shaft of the silico... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.
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