MEDLINE INDUSTRIES, LP - Northfield
707 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for MEDLINE INDUSTRIES, LP - Northfield and translate it into plain English — free weekly digest, optional same-day alerts.
- 2023-12-20FDA-DeviceClass IIMedline Leg bag, REF DYND12578
Undeclared latex
- 2023-12-20FDA-DeviceClass IIMedline Leg bag, REF DYND12574
Undeclared latex
- 2023-12-20FDA-DeviceClass IISTERILE POVIDONE, REF DYNDA2061
The product description on the labeling includes the word "Sterile" or STRL", however the contents of the solution inside the foil sachet is non-sterile.
- 2023-12-20FDA-DeviceClass IISTERILE BETADINE, REF DYNDA1998
The product description on the labeling includes the word "Sterile" or STRL", however the contents of the solution inside the foil sachet is non-sterile.
- 2023-12-20FDA-DeviceClass IIPVP SOLUTION SING STRL, REF DYNDA1858
The product description on the labeling includes the word "Sterile" or STRL", however the contents of the solution inside the foil sachet is non-sterile.
- 2023-12-20FDA-DeviceClass IISTERILE PVP, REF DYNDA1649
The product description on the labeling includes the word "Sterile" or STRL", however the contents of the solution inside the foil sachet is non-sterile.
- 2023-12-20FDA-DeviceClass IISTERILE STERILE PREP STICK, REF DYNDA1134
The product description on the labeling includes the word "Sterile" or STRL", however the contents of the solution inside the foil sachet is non-sterile.
- 2023-12-20FDA-DeviceClass IISTERILE PVP SLN KIT, REF DYNDM1097
The product description on the labeling includes the word "Sterile" or STRL", however the contents of the solution inside the foil sachet is non-sterile.
- 2023-12-20FDA-DeviceClass IISTERILE PVP SOLUTION, REF DYNDA1907
The product description on the labeling includes the word "Sterile" or STRL", however the contents of the solution inside the foil sachet is non-sterile.
- 2023-11-22FDA-DeviceClass IIBLOOD CULTURE KIT, REF DYNDH1647B
This recall is being issued due to items within the kit have expired prior to the overall kit expiration date listed on the insert.
- 2023-11-22FDA-DeviceClass II24 BLOOD CULTURE KIT, REF DYNDH1632
This recall is being issued due to items within the kit have expired prior to the overall kit expiration date listed on the insert.
- 2023-11-22FDA-DeviceClass IICENTRAL LINE BLOOD CULTURE DRA, REF DYNDH1562
This recall is being issued due to items within the kit have expired prior to the overall kit expiration date listed on the insert.
- 2023-11-22FDA-DeviceClass IIPERIPHERAL BLOOD CULTURE DRAW, REF DYNDH1561
This recall is being issued due to items within the kit have expired prior to the overall kit expiration date listed on the insert.
- 2023-11-22FDA-DeviceClass IIADLT BLOOD CULTURE COLLECT KIT, REF DYNDH1245
This recall is being issued due to items within the kit have expired prior to the overall kit expiration date listed on the insert.
- 2023-11-15FDA-DrugClass IIClinical TREAT Antifungal Powder, Vanilla Scent, 3 OZ (85 g) tube, Active Ingredient: Miconazole Nitrate 2.0% w/w Antifungal, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA, NDC: 53329-169-79
CGMP deviations: the product was shipped from the Manufacturer to a Medline warehouse and released to stock while it was still under investigation for low assay results on the active ingredient miconazole nitrate.
- 2023-10-25FDA-DeviceClass IIMEDLINE ReNewal Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/ GEN11 SW v2018-1 and Lower, REF HARH45R. surgical instrument.
Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on the packaging tray.
- 2023-10-25FDA-DeviceClass IIMEDLINE ReNewal Ligasure Sealer/Divider Nano-Coated Compatible with FT10 Generator, REF LF4418CR. electrosurgical instrument
Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on the packaging tray.
- 2023-10-25FDA-DeviceClass IIMEDLINE ReNewal Ligasure Maryland Jaw Sealer/Divider Nano-Coated Complatible with FT10 Generator, REF LF1944CR. electrosurgical instrument
Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on the packaging tray.
- 2023-10-25FDA-DeviceClass IIMEDLINE ReNewal Ligasure Blunt Tip Sealer/Divider Nano-Coated Compatible with FT10 Generator, REF LF1844CR. electrosurgical instrument
Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on the packaging tray.
- 2023-10-11FDA-DeviceClass IICenturion Sterile CirClamp with 1.45cm Bell Reprocessed, Reorder CR3145K, 1 per package, 12 per case.
The kits incorrectly contain CirClamp subassembly 345CRSAK which results in the kits containing an incorrect bell and base size.
- 2023-09-27FDA-DeviceClass IIMEDLINE STERILE IRIS SCISSORS CVD/STD, REF DYNJ04049
4.5" Iris Scissors, Sterile, Curved (DYNJ04049) are being recalled due to the potential of the tip protector to fall off. The sharp tip of the scissors could compromise the sterile barrier system by puncturing large and/or small holes that may not be visible to the user.
- 2023-09-20FDA-DeviceClass IHUDSON RCI Addipak, UNIT DOSE VIALS, 5mL Sterile 0.9% NaCl Solution for Inhalation USP. REF RHUD59U
Product dispositioned for scrap for sterility failure investigation that was inadvertently shipped to customers.
- 2023-08-16FDA-DeviceClass IITotal Hip Kit, REF DYNJ903275S; surgical convenience kit
The prep solution included in the Total Hip Kit expires prior to the expiration date of the Kit.
- 2023-08-09FDA-DeviceClass IICustom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. BREAST BIOPSY KIT, Model Number: DYNDA1224A, DYNDA1224B; b. BREAST BIOPSY TRAY, Model Number: SPEC0130C; c. BREAST IMAGING TRAY, Model Number: MNS11895; d. ULTRASOUND BREAST BIOPSY, Model Number: DYNDH1496; e. ULTRASOUND GUIDE BREAST BIOPSY, Model Number: DYNDH1319; f. US BREAST BIOPSY TRAY, Model Number: DYNDH1187A;
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
- 2023-08-09FDA-DeviceClass IICustom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIOGRAPHY PACK, Model Number: DYNJ65963A; b. ARTHOGRAM TRAY, Model Number: PAIN1524B; c. ARTHROGRAM TRAY, Model Number: PAIN1524A; d. CARPAL TUNNEL KIT, Model Number: DYNJ63149A; e. CRANIOTOMY CDS, Model Number: CDS981753L; f. CRANIOTOMY CDS-1, Model Number: CDS982889I; g. CRANIOTOMY PACK, Model Number: DYNJ61749A; h. DBD-JOINT INJECTION TRAY,
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
- 2023-08-09FDA-DeviceClass IICustom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CATH LAB PACK, Model Number: DYNJ58351A; b. PV CAROTID PACK, Model Number: DYNJ63341B;
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
- 2023-08-09FDA-DeviceClass IICustom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. EGG RETRIEVAL PACK, Model Number: DYNJ66291B; b. FETAL SURGERY CDS-LF, Model Number: CDS840214P; c. TVT PACK SMGH-LF, Model Number: DYNJ41913C;
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
- 2023-08-09FDA-DeviceClass IICustom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CUSTOM GYN, Model Number: DYNJ63257C; b. GYN EXP LAPAROTOMY, Model Number: DYNJ906578C; c. INTRAUTERINE TRNSFUSION -LF, Model Number: DYNJ9048708I; d. PERI NEURO BLOCK PACK-LF, Model Number: PHS762887001B; e. PICC TRAY, Model Number: DYNJ32988; f. SLING PACK-LF, Model Number: DYNJ55361, DYNJ55361A; g. TRANS VAGINAL TRAY (KW01JF), Model Number: OBQ056E
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
- 2023-08-09FDA-DeviceClass IICustom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. C V MINOR PACK, Model Number: DYNJ64862A; b. DBD-C SECTION ADM, Model Number: DYKL1816; c. FETAL SURGERY, Model Number: DYNJ908118A;
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
- 2023-08-09FDA-DeviceClass IICustom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CHN OR DAVINCI PROSTATE, Model Number: DYNJ902540N; b. CUSTOM GYN, Model Number: DYNJ63257B; c. DBD-AMNIOCENTESIS PACK-LF, Model Number: DYNJ0771979C; d. DBD-GYN EXP LAPAROTOMY, Model Number: DYNJ906578F; e. DBD-GYN LITHOTOMY, Model Number: DYNJ906579F; f. DBD-GYN LS, Model Number: DYNJ906616G; g. DBD-ROBOTICS GYN, Model Number: DYNJ905824I; h.
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
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