FDA Device Recalls

Recalls / Firms / Medline Industries Inc

Medline Industries Inc

135 FDA device recalls on record.

DateClassProductReason
2021-10-27Major Vascular CDS Convenience Kit
2021-10-27Bedside PICC CDS Convenience Kit
2021-10-27EVLP Convenience Pack/Kit
2021-10-27Venous Access Pack-LF Convenience Kit
2021-10-27Neuro Convenience Kit
2021-08-06NAMIC Stopcocks: (1) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015002, UPN H965700150021, Three-way S
2021-08-06NAMIC Manifolds. (1) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 64038301, UPN H96564038301
2021-07-01Medline Shoulder CDS convenience kits, REF DYNJ902837D and REF DYNJ902837F, containing expired compo
2021-07-01Medline Arthroscopy Kit, convenience kit, REF DYNJ904304B, containing expired component NaCl 3000mL
2021-07-01Medline Knee Arthroscopy Kit, convenience kit, REF DYNJ902838C, containing expired component NaCl 3
2021-07-01Medline Total Knee, convenience kit, REF DYNJ907129B, containing expired component NaCl 3000mL Irri
2021-05-25Cotton Rounds/Pads under the following brand names: 1. BEAUTY 360 Extra Large Premium Cotton Ovals
2021-04-30Medline Tissue Recovery Instrument Set, Reorder #DYNJ64347A, packaged 3/case, Sterile, Rx. Conveni
2021-03-15Diluent, Stat-Site B-HB, 6x 3ML - Product Usage: Intended to be used with the Stat-Site test strips
2021-01-25RNA MEDICAL, QCHGB HEMOGLOBIN CONTROL, MULTI, REF QC HGB - Product Usage: monitoring the performance
2021-01-15S-O303000 CONTROL, STAT-SITE B-HB, 2X3ML,1LOW,1HIGH - Product Usage: intended for the quantitative d
2020-11-13Thyroid Pack CKHA-LF, Model DYNJ50352B - Product Usage: This is a type of convenience kit used in va
2020-11-13Cardiac Pack - LF, Model DYNJ31903I - Product Usage: This is a type of convenience kit used in vario
2020-11-13Greffe Aorte-LF (product info is in French); Model DYNJ31877F - Product Usage: This is a type of con
2020-11-13Simple Neck Dissection, Model DYNJ47481C - Product Usage: This is a type of convenience kit used in
2020-11-13Resect. Intest. Laparo-LF, Model DYNJ42667A - Product Usage: This is a type of convenience kit used
2020-11-05RevMedX Trauma Dressings are packaged in a Tyvek Peel pouch, 1 Trauma Dressing per Tyvec Peel Pouch,
2020-10-01The Quidel Triage BNP Calibrators
2020-09-15Quick Release Gait Belt, 60
2020-09-14Kit Model #65021652, MTO Left Heart Kit United Reg Health - Product Usage: NAMIC Cath Lab and Interv
2020-09-14Kit Model #65193091, MTO Left Heart Kit - Product Usage: NAMIC Cath Lab and Interventional Radiology
2020-09-14Kit Model #650301023, MTO Radiology Kit Cleveland Clinic - Product Usage: NAMIC Cath Lab and Interve
2020-09-14Kit Model #650301018, MTO Vascular Surgery - Cleveland Clinic PG - Product Usage: NAMIC Cath Lab and
2020-09-14Kit Model #650304917, MTO Protection Station Plus with Drape - Product Usage: NAMIC Cath Lab and Int
2020-09-14Kit Model #650305414, MTO Left Heart with DT Boulder Com Hosp - Product Usage: NAMIC Cath Lab and In
2020-09-14Kit Model #65220955, MTO Left Heart Kit VA Med San Francisco - Product Usage: NAMIC Cath Lab and Int
2020-09-14Kit Model #650600111, MTO Left Heart St Francis Hosp - PG - Product Usage: NAMIC Cath Lab and Interv
2020-09-01ClearPro Closed Suction Catheter, Model DYNCPDS14T, 14 Fr FOR ENDOTRACHEAL TUBE - Product Usage: Ca
2020-08-12Central Line Dressing Change Tray
2020-07-28Control, Calibrator Verified, Triage BNP, Model ALR88755
2020-07-09Endoscopic Cleaning Brush - Product Usage: Endoscopic cleaning brushes are single use devices intend
2020-06-30ClearPro Trach T-Piece Closed Suction Catheter, Model DYNCPTP14T, 14 Fr 12.5 IN FOR TRACHEOSTOMY TUB
2020-06-30ClearPro T-Piece Closed Suction Catheter, Model DYNCPTP14, 14 Fr 21.3 IN FOR ENDOTRACHEAL TUBE - Pro
2020-03-09Custom convenience kits containing Medline brand Sterile Pre-Saturated Povidone Iodine Sponge Produc
2020-02-10Medline Winged Sponges Presaturated W/PVP REF DYND70289 DYND70289H Expiration 06/30/2022.
2020-02-10Medline Sterile 3mL Syringes with 21GA x 1 Inch Needle 80 each REF DYND3ML21G1A lot 18JBH655 (01) 10
2020-02-10Medline Stick Sponge Presaturated W/PVP REF DYND70288 DYND70288H 2/PK Expiration 06/30/2022.
2020-01-21Medline ROBOTIC-LF REF CDS984543B Lot 20AKA927 Expiration 2020-09-30 GTIN (01)10888277056350
2020-01-21Medline HOI LUMBAR REF DYNJ902823G Lot 20AKA895 Expiration 2021-05-31 1 each GTIN (01)10193489219180
2020-01-07Medline DYNDA1928 VP TRAY WITH PVP Packaged in Mexico GLOVE:Made in Malaysia APPLICATOR:Made in Chi
2019-10-30Anesthesia Pediatric Circuit 72", Model DYNJAPF6057A
2019-09-18EVENCARE G3 Blood Glucose Test Strips, 1 test strip per foil pouch, 50 foil pouches per box, 12 boxe
2019-09-06MEDLINE ELECTRIC SURGICAL CLIPPER AND BASE, REF DYND70800 Product Usage: Medline Surgical Clipper i
2019-08-09Medline SYRINGE, PISTON,IRR TRAY,W/.9, REF DYNC2303. Sterile Piston Irrigation Syringe Tray with Sa
2019-05-30Anti-fog solution packaged in a Tyvek peel pouch and it is placed into various kits. Kit are labele
2019-05-28SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 6 Fr 1.5 ml - Product Usage: Medline Silicone Fol
2019-05-28SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 8 Fr 3 ml - Product Usage: Medline Silicone Foley
2019-05-28SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 10 Fr 3 ml - Product Usage: Medline Silicone Fole
2019-05-10Centurion Convenience Kits, containing BD Alaris Pump Infusion Sets. BD code 11522558 (Centurion cod
2019-05-03Medline Primary Warmer Pack, Product No. DYNJ52510A. The Medline Primary Warmer Pack contains the re
2019-04-25Endoscopic Cleaning Brushes sold in various Endoscopy Kits - Product Usage: The brushes are used to
2019-01-31Semi-Rigid Suction Canister, 3000cc. Model Numbers OR530 and OR530H. For OR530, the product comes
2018-08-30Unna-Z: Unna Boot Compression Wrap with Zinc Oxide and Calamine, Item Numbers: a) NONUNNA3 and b) N
2018-06-15Endoscopic Cleaning Brush, single use, sold in kits and labeled as the following: a. Item Number
2018-04-24MEDLINE O.R. Necessities(TM) Sterile* Needle Counter, 40 Ct. Double Magnet / Foam Block with Blade R
2018-04-24MEDLINE O.R. Necessities(TM) Sterile* Needle Counter, 100 Ct. Double Magnet / Foam Block with Blade
2018-04-24MEDLINE O.R. Necessities(R) STERILE R, Needle Counter/Compte-aiguiles/Caja de agujas, Gold Standard/
2018-04-24MEDLINE Sterile* Needle Counter, 100Ct. Double Magnet / Foam Block, reorder: DYNJNC100F Product Usa
2018-04-24MEDLINE Sterile* Needle Counter, 40Ct. Foam Block / Adhesive, reorder: DYNJNC40A Product Usage: A n
2018-04-24MEDLINE Sterile* Needle Counter, 40Ct. Foam Block / Magnet, reorder: DYNJNC40F Product Usage: A need
2018-02-01Medline 0.9 % Sodium Chloride Injection, USP 5 mL in 10 mL Syringe ZR Intended for flushing IV
2018-01-12BARD MYPICC Kit, REF CK000095B, 5F French Size, packaged 5 kits/case, Sterile, RX, For use in vascul
2017-10-23Sensicare Green Surgical Glove, PI, LF, PF. Packaged in a poly/poly peel pouch with Sunoco films, s
2017-10-10MEDLINE DOUBLE SWIVEL CLOSED SUCTION CATHETER, 21.3 in (54 cm) FOR ENDOTRACHEAL TUBE, 12 Fr, REF DYN
2017-10-10MEDLINE PEDI ELBOW CLOSED SUCTION CATHETER, 8Fr, REF DYNCPE8
2017-08-10Transfer/Gait Belt, Plastic, Wipeable, packaged in plastic bag, 36 plastic bags per box.
2017-08-10Transfer/Gait Belt, Plastic, Wipeable, packaged in plastic bag, 36 plastic bags per box.
2017-07-18Sterile Elastic Esmark Bandage, 3" x 9", individually packaged in a Tyvek plastic form fill seal pou
2017-04-12PICC Tray, STERILE, 12 packs each per case.
2017-04-12Laparoscopy CDS
2017-04-12Art-Line Surgery Pack-LF, STERILE, 40 packs each per case.
2017-04-12Cardiac Insulation Pad, OPEN HEART CDS
2017-04-12LASER CDS
2016-12-1412 mm Distraction Pin, Blunt Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., M
2016-12-1416 mm [or 18 mm] Distraction Pin, Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, In
2016-12-1414 mm Distraction Pin, Exagg Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., M
2016-12-1410 mm Distraction Pin, Aggressive Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, In
2016-12-1416 mm Distraction Pin, Titanium, Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc
2016-11-23Unna-Z, Unna Boot with Zinc and Calamine, Compression Wrap, 1 Per Box, 3-4in x 10yds
2016-08-10Rigid Suction Canister 3000 CC and 2000 CC.
2016-05-11Medicine Cup, 1 OZ. Liquid medication dispenser to issue a measured amount of liquid medication.
2015-08-03Central Line >34 Weeks Kit. Cardiology department. The Central Line >34 Weeks Kit (DYNDC1987A) is in
2015-07-08Medline Electrical Clipper with Charging base The Electrical Surgical Clipper is intended for the
2014-03-20Esmark Elastic Bandage (Sterile), 4" x 9'. Item DYNJ05116A, Individually wrapped, 20 bandages per ca
2013-11-04Mucus Specimen Trap 40 cc, Specimen Trap 40 cc with additional transport cap; Product number DYND44
2013-08-14HEART CATH CUSTOM PACK; REF: DYNJ39747A; Packaged in Mexico by: Medline Industries, Inc., Mundelein,
2013-08-14ANGIO PACK #2; REF: DYNJ39185; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060;
2013-08-14ANGIOGRAPHY PACK; REF: DYNJ26855D; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60
2013-08-14STERILE SAMPLE BUILD; REF: SAMP0147; Packaged for Medline Industries, Inc., Mundelein, IL 60060; 1-8
2013-08-14CATH LAB CUSTOM PACK; REF: DYNJ40926; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL
2013-08-14CATH PACK; REF: DYNJ41103; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-8
2013-08-14CATH PACK; REF: DYNJ40904; Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060; 1-8
2013-08-14STERILE SAMPLE BUILD; REF: SAMP0144; Packaged for Medline Industries, Inc., Mundelein, IL 60060; 1-8
2013-08-14STERILE SAMPLE CATH LAB PACK; REF: SAMP0213; Packaged for Medline Industries, Inc., Mundelein, IL 60
2013-08-14CATH TRAY; REF: DYNJ41101; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-8
2013-08-14CATH ANGIOGRAPHY DRAPE PACK; REF: DYNJ40851; Packaged in Mexico for Medline Industries, Inc., Mundel
2012-11-08Medline Angio Drape Pack Radiology-LF; a sterile custom single patient prescription procedure pack,
2012-09-20Medline Total Knee CDS; a single patient prescription procedure pack and disposables, including a ba
2011-02-03Medline Industries, Inc. "Cedar" brand Vinyl Economy Exam Glove, Powder-Free, Large Size, Catalog Nu
2011-02-03Medline Industries, Inc. "Cedar" brand Vinyl Economy Exam Glove, Powder-Free, Medium Size, Catalog N
2008-08-04Medline Latex Free C-Section CDS-LF and C-Section Supplemental CDS-LF; a single patient prescription
2008-08-04Medline Latex Free Vaginal Delivery CDS-LF; a single patient prescription procedure pack and disposa
2008-08-04Medline Latex Free Mom/Baby Admit Kit - LF; a single patient prescription procedure pack and disposa
2008-08-04Medline Latex Free Labor Kit & Postpartum CDS-LF; a single patient prescription procedure pack and d
2008-08-04Medline Latex Free Labor & Delivery CDS-LF; a single patient prescription procedure pack and disposa
2008-06-13Medline RF Detect Sterile X-Ray Detectable USP Type VII Gauze; 8" x 4", 12-ply, 100% cotton sponges,
2008-03-31Bariatric Wheelchair, 26" Wide and 20" Deep Seat, 700 lb. Weight Capacity; Manufactured in Taiwan fo
2008-03-31Bariatric Wheelchair, 24" Wide and 19" Deep Seat, 600 lb. Weight Capacity; Manufactured in Taiwan fo
2008-03-31Bariatric Wheelchair, 28" Wide and 20" Deep Seat, 700 lb. Weight Capacity; Manufactured in Taiwan fo
2008-03-04Medline EndurO2 Oxygen Concentrator with Oxygen Monitor; Portable oxygen generator; Reorder Number:
2008-03-04Medline EndurO2 Oxygen Concentrator without Oxygen Monitor; Portable oxygen generator; Reorder Numbe
2007-12-072 Liter Latex-Free Breathing Bag; Reservoir Bag; Vendor Part Number: 720058B, Medline Item Number: 4
2007-12-071 Liter Latex-Free Breathing Bags; Reservoir Bag; Vendor Part Number: 720059B, Medline Item Number:
2007-12-073 Liter Latex-Free Breathing Bag; Reservoir Bag; Vendor Part Number: 720057B, Medline Item Number: 4
2006-11-21Medline Premium Wet Skin Prep Tray, Sterile, Latex Free; a single use surgical convenience tray, EO
2006-07-20Medline Strider Midi 4 Scooter; a four wheeled battery operated scooter; manufactured by KYMCO, Kaoh
2006-07-20Medline Strider Maxi 4 Scooter; a four wheeled battery operated scooter; manufactured by KYMCO, Kaoh
2006-07-20Medline Strider Midi 3 Scooter; a three wheeled battery operated scooter; manufactured by KYMCO, Kao
2006-07-20Medline Strider Maxi 3 Scooter; a three wheeled battery operated scooter; manufactured by KYMCO, Kao
2006-03-30Proxima Sterile, Disposable Set Up Pack III, Reorder DYNJP1047; a sterilized convenience kit for sur
2005-03-18Medline Custom Open Heart CDS Kit (non-sterile), reorder number CDS840144A, which contains Meridian
2005-03-18Medline Custom Anesthesia Circuit 40in Adult Unilimb Kit (non-sterile), reorder number DYNJAA4315; t
2005-03-18Medline Custom Anesthesia Super Circuit Adult 60 Unilimb Kit (non-sterile), reorder number DYNJAAF62
2005-03-18Medline Custom Anesthesia Circuit 40in Adult Unilimb Kit (non-sterile), reorder number DYNJAAF4304B;
2005-03-18Medline Custom Anesthesia Circuit Adult 40in Mask 3L Kit (non-sterile), reorder number DYNJAA4749; t
2005-03-18Medline Custom Anesthesia Set Up Kit - Latex Free (non-sterile), reorder number DYNJAA0078C; the kit
2005-03-04Medline Custom Sterile Surgical Packs which contain a Tyvek Breather Pouch, part number 32901, lot n
2003-10-07Medline Blue O.R. Towel, Sterile; Reorder MDT2168204; 4 towels per pack, 20 packs per case; Medline
2003-02-12Sterile 8 Fr Suction Catheter Kit - Latex Free; Medline Industries, Inc., Mundelein, IL 60060-4488;
2003-02-12Sterile Dressing Change Tray with CloraPrep - Latex Free; Medline Industries, Inc., Mundelein, IL 60