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.
- 2025-01-08FDA-DeviceClass IIMedline custom medical procedure kits labeled as: 1) OPEN HEART CDS-LF, REFCDS840451M; 2) NEURO PACK, REFDYNJ41516M; 3) RFD- AAA PACK, REFDYNJ54242B; 4) OPEN HEART A&B, REFDYNJ901203C; 5) OPEN HEART A&B, REFDYNJ901203D; 6) ACDF-LF, REFDYNJ906681B; 7) ACDF-LF, REFDYNJ906681C.
Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
- 2025-01-08FDA-DeviceClass IIMedline custom medical procedure kits labeled as: 1) CATH LAB PACK-LF, REF DYNJ0382559M; 2) CRANI, REF DYNJ56001B; 3) GENDER AFFIRMING SURGERY, REF DYNJ66252; 4) GENDER AFFIRMING SURGERY, REF DYNJ66252A; 5) MAJOR NEURO PACK-LF, REF DYNJ0578916X.
Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
- 2025-01-01FDA-DeviceClass IIRUMMELL, Medline Item No. ST006ST
Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
- 2025-01-01FDA-DeviceClass IIST IUD REMOVAL HOOK 10" (504090), Medline Item No. I68785
Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
- 2025-01-01FDA-DeviceClass IIST REPROCESSED BRUNS CURETTE #00 (BC00), Medline Item No. 67600K
Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
- 2025-01-01FDA-DeviceClass IISTERILE MAGILL FORCEP (MAGF9), Medline Item No. 66790
Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
- 2025-01-01FDA-DeviceClass IIST OR MAYO HEGAR NEEDLEHOLDER 6"(OR2500), Medline Item No. 67870
Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
- 2025-01-01FDA-DeviceClass IIO.R. SCISSORS, S/B, 5.5 STERILE, Medline Item No. DYND04000
Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
- 2025-01-01FDA-DeviceClass IISTERILE STRT KELLY HEMOSTAT (SK8039S), Medline Item No. 66695
Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
- 2025-01-01FDA-DeviceClass IIMedline brand, medical procedure convenience kits, labeled as: 1) LAMINECTOMY CDS-LF, SKU CDS780045N; 2) NEURO CRANIOTOMY CDS #36-RF, SKU CDS780119U; 3) NEURO CRANIOTOMY CDS #36-RF, SKU CDS780119V; 4) CRANIOTOMY CDS, SKU CDS981753K; 5) LAMINECTOMY CDS-LF, SKU CDS981923X; 6) CRANIOTOMY, SKU CDS982719Q; 7) CRANIOTOMY, SKU CDS982719R; 8) CRANIOTOMY, SKU CDS982719S; 9) CRANIOTOMY, SKU CDS982719T; 10) CRANIOTOMY, SKU CDS982719U; 11) CRANIOTOMY, SKU CDS982719V; 12) CRANIOTOMY, SKU CDS98271
Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods
- 2025-01-01FDA-DeviceClass IIKIT,SPINE LH Convenience kit, SKU DYNJ906448A.
Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods
- 2025-01-01FDA-DeviceClass IIMedline brand, medical procedure convenience kits, labeled as: 1) NEURO CRANIOTOMY CDS #36-RF, SKU CDS780119T; 2) NEURO KIT, SKU CDS981327Q; 3) NEURO POSTERIOR SPINE PACK-LF, SKU DYNJ0311501I; 4) ACOUSTIC NEUROMA PACK-LF, SKU DYNJ37741D; 5) SCRIPPS SW NEURO PACK-LF, SKU DYNJ39836C; 6) SCRIPPS SW NEURO PACK-LF, SKU DYNJ39836D; 7) NEURO BUNDLE-LF, SKU DYNJ40095A; 8) NEURO BUNDLE-LF, SKU DYNJ40095B; 9) NEURO BUNDLE-LF, SKU DYNJ40095C; 10) NEURO BUNDLE-LF, SKU DYNJ40095D; 11) NEU
Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods
- 2025-01-01FDA-DeviceClass IIMedline brand, medical procedure convenience kits, labeled as: 1) CRANIOTOMY, SKU CDS982719X; 2) MVFF/FIBU #54-RF, SKU DYNJ21927Q; 3) MVFF/FIBU #54-RF, SKU DYNJ21927S; 3) NEURO PEDIATRIC, SKU DYNJ61607A; 4) CRANIOTOMY PACK, SKU DYNJ66419C; 5) LYMPHATIC BYPASS PACK, SKU DYNJ69907; 6) LYMPHATIC BYPASS PACK, SKU DYNJ69907A; 7) HEAD AND NECK PACK - 51597, SKU DYNJ81934B; 8) MAJOR CRANIOTOMY PACK, SKU DYNJ82007A; 9) SPINE PACK, SKU DYNJ82011A; 10) CRANIOTOMY MERCY STK 256, SKU DYNJ84068; 11) WMC UN
Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods
- 2025-01-01FDA-DeviceClass IISEPTOPLASTY PACK Convenient kit, SKU DYNJ44759F. Convenience kits used for various procedures.
Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods
- 2025-01-01FDA-DeviceClass IIMedline brand, medical procedure convenience kits, labeled as: 1) MVFF/FIBU #54-RF , SKU DYNJ21927R; 2) DIEP FLAP, SKU DYNJ910120A
Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods
- 2025-01-01FDA-DeviceClass IIMedline brand, medical procedure convenience kits, labeled as: 1) SINUS CDS-1, SKU CDS982901F; 2) NASAL PACK, SKU DYNJ17493G; 3) FESS PACK-POB, SKU DYNJ33520A; 4) SINUS PACK, SKU DYNJ44845G; 5) SINUS PACK, SKU DYNJ48330B; 6) ENT PACK, SKU DYNJ50572; 7) ENT PACK, SKU DYNJ53573A; 8) ENT HUTCH, SKU DYNJ58856A; 9) PACK NASAL, SKU DYNJ60111A; 10) PACK NASAL, SKU DYNJ60111B; 11) ENT CUSTOM PACK, SKU DYNJ63052C; 12) ENT PACK, SKU DYNJ64256D; 13) FESS/SEPTOPLASTY PACK, SKU DYNJ64509B; 14) SINUS ENDOSCOP
Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods
- 2025-01-01FDA-DeviceClass IIDIEP FLAP Convenience kit, SKU DYNJ910120. Convenience kits used for various procedures.
Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods
- 2025-01-01FDA-DeviceClass IIFESS-MB PACK-LF Convenience kit, SKU DYNJ0888159I. Convenience kits used for various procedures..
Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods
- 2025-01-01FDA-DeviceClass IIMAJOR NEURO PACK-LF Convenience kit, SKU DYNJ0578916X. Convenience kits used for various procedures.
Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods
- 2024-12-25FDA-DeviceClass IIHUDSON RCI mBrace, ET Tube Holder with Bite Block and 4 Point Head Strap, REF DYNJMBRC4B; tracheal tube fixation device
Complaint defects have been noted regarding the adhesive elements of the device and the frame of the holder putting additional pressure on the patient's cheekbones and upper lip which may cause dermal injury depending on the device positioning.
- 2024-12-25FDA-DeviceClass IIHUDSON RCI mBrace, ET Tube Holder with 4 Point Head Strap, REF DYNJMBRC4; tracheal tube fixation device
Complaint defects have been noted regarding the adhesive elements of the device and the frame of the holder putting additional pressure on the patient's cheekbones and upper lip which may cause dermal injury depending on the device positioning.
- 2024-12-25FDA-DeviceClass IIHUDSON RCI mBrace, ET Tube Holder with Bite Block and 2 Point Head Strap, REF DYNJMBRC2B; tracheal tube fixation device
Complaint defects have been noted regarding the adhesive elements of the device and the frame of the holder putting additional pressure on the patient's cheekbones and upper lip which may cause dermal injury depending on the device positioning.
- 2024-12-25FDA-DeviceClass IIHUDSON RCI mBrace, ET Tube Holder and 2 Point Head Strap, REF DYNJMBRC2; tracheal tube fixation device
Complaint defects have been noted regarding the adhesive elements of the device and the frame of the holder putting additional pressure on the patient's cheekbones and upper lip which may cause dermal injury depending on the device positioning.
- 2024-12-11FDA-DeviceClass IIMEDLINE convenience kits labeled as: 1) ORTHO LAMINECTOMY-LF, REF CDS780112J; 2) NEURO CRANIOTOMY CDS #36-RF, REF CDS780119V; 3) BASIC BACK CDS, REF CDS780147N; 4) INSTRUMENTED BACK CDS, REF CDS780148Q; 5) INSTRUMENTED BACK CDS, REF CDS780148R; 6) TOTAL HIP, REF CDS920027W; 7) TOTAL HIP, REF CDS920027X; 8) TOTAL HIP, REF CDS920027Y; 9) TOTAL KNEE CDS-LF, REF CDS940047AF; 10) TOTAL KNEE CDS-LF, REF CDS940047AG; 11) TOTAL HIP CDS-LF, REF CDS940048AF; 12) TOTAL HIP CDS-LF, REF CDS94004
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
- 2024-12-11FDA-DeviceClass IIMEDLINE convenience kits labeled as: 1) MINOR EYE TRAY #81, REF DYNJ27466S; 2) EYE PACK, REF DYNJ41207C; 3) CATARACT PACK, REF DYNJ43147G; 4) OSC OCULOPLASTIC PACK, REF DYNJ63329D; 5) OSC OCULOPLASTIC PACK, REF DYNJ63329F; 6) OCULAR PACK, REF DYNJ64138B; 7) OSC BREAST PACK, REF DYNJ65808C; 8) OCULOPLASTY PACK, REF DYNJ81798A; 9) OPHTHO PLASTIC, REF DYNJ902256C; 10) OCULAR, REF DYNJ909065; 11) OCULAR, REF DYNJ909065A; 12) PLASTIC EYE, REF DYNJVB91043A
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
- 2024-12-11FDA-DeviceClass IIMEDLINE convenience kits labeled as: 1) TOT/ GYN LITHOTOMY CDS, REF CDS985431J; 2) TOT/ GYN LITHOTOMY CDS, REF CDS985431K; 3) TOT/ GYN LITHOTOMY CDS, REF CDS985431L; 4) GENERAL LITHOTOMY PACK, REF DYNJ44153G; 5) CHRISTUS AH GYN LAPAROSCOPY, REF DYNJ60924C; 6) D&C PACK, REF DYNJVB1280C; 7) D&C PACK, REF DYNJVB1280D
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
- 2024-12-11FDA-DeviceClass IIMEDLINE convenience kits labeled as: 1) MAJOR LITHOTOMY CDS-LF, REF CDS760056G; 2) LAVH CDS, REF CDS983411J; 3) MAJOR VAGINAL, REF CDS983497L; 4) DAY SURG LARGE VAG CDS, REF CDS984995N; 5) GYN LAPAROTOMY HARPER PACK-LF, REF DYNJ0160684F; 6) D&C/HYSTEROSCOPY PACK, REF DYNJ01921M; 7) HYSTERECTOMY PACK-LF, REF DYNJ0488471K; 8) VAG HYST PACK-LF, REF DYNJ0532873M; 9) VAG HYST PACK-LF, REF DYNJ0532873N; 10) VAGINAL PROCEDURES PACK-LF, REF DYNJ0750737Q; 11) MINOR VAGINAL #76-RF,
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
- 2024-12-11FDA-DeviceClass IIMEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075V; 2) C-SECTION OR 30 CDS, REF CDS820075W; 3) C-SECTION, REF CDS980774M; 4) C-SECTION KIT, REF CDS981322AB; 5) C-SECTION KIT, REF CDS981322AC; 6) C-SECTION COMBINED CDS, REF CDS982398I; 7) C-SECTION PROCEDURE, REF CDS983450L; 8) C-SECTION-LF, REF CDS983869J; 9) C-SECTION, REF CDS984261J; 10) C-SECTION CDS-LF, REF CDS984516L; 11) C-SECTION CDS-LF, REF CDS984516M; 12) C-SECTION, REF CDS984902K; 13) C-SECTION, R
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
- 2024-12-11FDA-DeviceClass IIMEDLINE convenience kits labeled as: 1) CIRCUMCISION PACK, REF DYNJ16826O; 2) D-CIRCUMCISION PACK, REF DYNJ64432; 3) PACK,CIRCUMCISION ASC, REF DYNJ906909A
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
- 2024-12-11FDA-DeviceClass IIMEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY-LF, REF CDS760059I; 2) GYN LAPAROSCOPY CDS #34-RF, REF CDS920099S; 3) GYN MAJOR, REF CDS980998L; 4) ROBOTIC PROCEDURE, REF CDS982128P; 5) ROBOTIC, REF CDS984262N; 6) GYN LAPAROSCOPY, REF CDS984900M; 7) GYN LAPAROSCOPY, REF CDS984900N; 8) DAVINCI PACK-LF, REF DYNJ0101304G; 9) PROSTATE ROBOTIC PACK, REF DYNJ0347372J; 10) URO GYN PACK-LF, REF DYNJ17454N; 11) DB DAVINCI ROBOT PACK-LF, REF DYNJ33592I; 12) ROBOTIC UROLOGY
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
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