The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

7276–7300 of 52964

  • HighFDA (Devices)·Z-3027-2024·2024-09-18

    Medline Medical Convenience Kits Recalled for Defective Plastic Syringes

    Medline medical convenience kits containing defective plastic syringes are being recalled due to leaks, breakage, and quality issues. The affected devices have been distributed worldwide and may pose a risk to patient health.

    Product
    Medline Convenience kits labeled as: 1) 6" FEMORAL ARTERIAL LINE KIT- ICU, Pack Number ART245C; 2) CHEST TUBE INSERTION TRAY, Pack Number CHT1900; 3) CHEST TUBE INSERTION TRAY, Pack Number CHT560; 4) CHEST TUBE INSERTION TRAY, Pack Number CHT705; 5) PORT TRAY , Pack Nu
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2999-2024·2024-09-18

    Medline Medical Convenience Kits Recalled for Defective Plastic Syringes

    Medline is recalling medical convenience kits containing plastic syringes affected by quality issues including leaks and breakage. The defects may pose risks during dental and surgical procedures.

    Product
    Medline Convenience kits labeled as: 1) OSTEOTOMY ORAL PROCEDURE, Pack Number CDS983010J ; 2) ORAL SURGERY PACK , Pack Number DYNJ00354K ; 3) ORAL PACK-LF, Pack Number DYNJ0426048L ; 4) ORAL SURGERY PACK-LF, Pack Number DYNJ17477F ; 5) ORAL SURGERY PACK-LF, Pack Number
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3042-2024·2024-09-18

    Medline Medical Convenience Kits Recalled Due to Defective Plastic Syringes

    Medline is recalling multiple medical convenience kits containing plastic syringes due to identified leaks, breakage, and quality issues. These defects may pose a risk to patient health.

    Product
    Medline Convenience kits labeled as: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401327AA; 2) CORONARY ANGIO PACK-LF, Pack Number 00-401594R ; 3) IR NEURO INTERVENTIONAL PACK, Pack Number 00-401808S ; 4) NEURO CDS , Pack Number CDS780056K ; 5) NEURO CDS , Pack Number CDS78005
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3110-2024·2024-09-18

    Medline Semi-Rigid Suction Liners Recalled for Potential Loss of Suction

    Medline Industries is recalling specific convenience kits with semi-rigid suction liners due to reported adverse events and potential loss of suction during intermittent use. Affected: 358 units distributed in US, Canada, and Panama.

    Product
    Medline convenience kits containing semi-rigid suction liners labeled as follows: a) MINOR PROCEDURE, Pack Number CDS981509C; b) GENERAL LAPAROSCOPY CDS, Pack Number CDS981512J; c) OR MAJOR CDS, Pack Number CDS981515D; d) MAJOR-LF, Pack Number DYNJ900709C; e) MAJOR-LF, P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3107-2024·2024-09-18

    Medline Surgical Suction Liners Recalled for Potential Loss of Suction

    Medline Industries is recalling 1,646 units of semi-rigid suction liners used in surgical kits due to reported adverse events involving potential loss of suction or low suction during intermittent use.

    Product
    Medline convenience kits containing semi-rigid suction liners labeled as follows: a) OPEN HEART KIT,ALTA BATES HOSP, Pack Number DYK1002174I; b) ENDO KIT, Pack Number DYKE1558B; c) ENDO KIT, Pack Number DYKE1804A; d) VASCULAR-LF, Pack Number DYNJ900714C; e) MAJOR CARDI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2994-2024·2024-09-18

    Medline Vascular IVC Filter Placement Kits Recalled for Syringe Defects

    Medline is recalling vascular IVC filter placement kits containing defective plastic syringes due to leaks and breakage that may pose health risks. The affected kits are distributed worldwide.

    Product
    Medline Convenience kits labeled as: KIT VASCULAR IVC FILTER PLACEM, Pack Number DYKMBNDL37AH
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3032-2024·2024-09-18

    Medline Convenience Kits with Plastic Syringes Recalled Due to Leaks and Breakage

    Medline has recalled convenience kits containing plastic syringes due to leaks, breakage, and quality issues that may pose risks to patient health. The recall affects multiple lot numbers distributed worldwide.

    Product
    Medline Convenience kits labeled as: 1) SYR CONTROL PAD 12ML L/L, Pack Number DYNJSYR12CP; 2) MSC - AHMC ANAHEIM REG MED CTR, Pack Number 148056; 3) MSC - JOHN MUIR MC, Pack Number 150206
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3020-2024·2024-09-18

    Medline Recalls Medical Convenience Kits with Defective Plastic Syringes

    Medline Industries is recalling medical convenience kits containing plastic syringes affected by an FDA Safety Alert due to leaks, breakage, and quality issues.

    Product
    Medline Convenience kits labeled as: 1) PRESSURE TUBING B.I., Pack Number 81239; 2) M1S1109 TRADITIONAL PROCESS-LF, Pack Number 946279 ; 3) 20GX6" FEMORAL ART LINE KIT, Pack Number ART1165; 4) 3" RADIAL ARTERIAL LINE KIT- OR, Pack Number ART1210; 5) 3" RADIAL ARTERIAL LINE
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3041-2024·2024-09-18

    Medline Medical Convenience Kits with Plastic Syringes Recalled Due to Leaks and Breakage

    Medline Industries is recalling medical convenience kits containing plastic syringes with leaks, breakage, and other quality issues that may pose a risk to patient health.

    Product
    Medline Convenience kits labeled as: 1) CHEST TUBE INSERTION TRAY, Pack Number DYNDA2063; 2) PULL D/C PACK, Pack Number DYNDA2080; 3) STERILE 3CC SYR W/ 23GX1 NDL, Pack Number DYNDA2495; 4) STERILE 1CC SYR W/ 25GX5/8 NDL, Pack Number DYNDA2497; 5) ARTHROGRAM TRAY, Pack
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3131-2024·2024-09-18

    Surgical Dissector Recalled for Brown Discoloration on Hinge Area

    Technomed Europe is recalling NEUROSIGN Disposable Stimulating Dissectors due to brown discoloration or substance on the hinge area. The recall affects 71 units distributed across seven US states.

    Product
    NEUROSIGN Disposable Stimulating Dissector, REF 5888-00
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-3019-2024·2024-09-18

    Medline Medical Convenience Kits Recalled for Defective Syringes

    Medline Industries recalls numerous sterile procedure kits containing plastic syringes affected by an FDA Safety Alert from March 2024. The syringes may leak or break, posing potential risk to patient health.

    Product
    Medline Convenience kits labeled as: 1) MYELOGRAM PACK, Pack Number 00-399025L ; 2) BIOPSY PROCEDURE PACK , Pack Number 00-399227G ; 3) BIOPSY PROCEDURE PACK, Pack Number 00-399607N; 4) THORACENTESIS TRAY, Pack Number 00-400616J ; 5) SPECIAL PROCEDURE PACKX-RAY , Pack Numbe
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3011-2024·2024-09-18

    Medline Recalls Dialysis Convenience Kits Due to Syringe Quality Issues

    Medline is recalling dialysis convenience kits containing plastic syringes affected by an FDA Safety Alert. Leaks and breakage may pose a risk to patient health.

    Product
    Medline Convenience kits labeled as: 1) DIALYSIS CATH ACCESS KIT, Pack Number DYNDA2516B ; 2) DIALYSIS CATH ACCESS KIT, Pack Number DYNDA2516BH; 3) DIALYSIS PACK , Pack Number DYNJ36932A ; 4) DIALYSIS AV SHUNT #668229-V-LF, Pack Number DYNJ58502C ; 5) DIALYSIS ACCESS P
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3104-2024·2024-09-18

    ADVIA Centaur CA 19-9 test kit recalled for measurement bias in samples

    Siemens Healthcare is recalling ADVIA Centaur CA 19-9 diagnostic test kits due to positive measurement bias in some samples. The affected kits may report falsely elevated test results, particularly around the normal limit of 35 U/mL.

    Product
    ADVIA Centaur CA 19-9 (250 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers SMN: 10491244
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3054-2024·2024-09-18

    Medline Recalls Arthroscopy Kits with Defective Plastic Syringes

    Medline Industries is recalling various arthroscopy and arthrogram convenience kits because they contain plastic syringes affected by a March 2024 FDA Safety Alert. The syringes have leaks, breakage, or other quality issues that may pose a risk to patient health.

    Product
    Medline Convenience kits labeled as: 1) ARTHROGRAPHY DRAPE PACK , Pack Number 00-399027M ; 2) ARTHROSCOPY CDS , Pack Number CDS940242I ; 3) ARTHROSCOPY-LF, Pack Number CDS940859J ; 4) KNEE ARTHROSCOPY CDS-LF , Pack Number CDS940869U ; 5) ARTHROSCOPY CDS , Pack Number CDS940
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3048-2024·2024-09-18

    Medline C-Section Convenience Kits Recalled for Syringe Quality Issues

    Medline is recalling C-section convenience kits because they contain plastic syringes affected by a March 2024 FDA Safety Alert. The syringes may leak or break, posing a risk to patient health.

    Product
    Medline Convenience kits labeled as: 1) C-SECTION TRAY, Pack Number AM160B ; 2) C-SECTION TRAY, Pack Number AM160C ; 3) C-SECTION CDS , Pack Number CDS820031I ; 4) C-SECTION CDS , Pack Number CDS820031J ; 5) C-SECTION PACK, Pack Number CDS820081K ; 6) C-SECTION PACK, Pack
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3014-2024·2024-09-18

    Medline Paracervical Pudendal Block Kits Recalled for Syringe Quality Issues

    Medline is recalling Paracervical Pudendal Block kits because the included plastic syringes have leaks, breakage, or other quality issues that may risk patient health.

    Product
    Medline Convenience kits labeled as: PARACERVICAL PUDENDAL BLOCK TR, Pack Number DYNJRA1023
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3128-2024·2024-09-18

    Medtronic Venous Cannulae: Wrong Product in Incorrect Packaging

    Medtronic Perfusion Systems is recalling 290 units of DLP Single Stage Venous Cannulae due to a manufacturing error where straight-tip cannulae were placed into packaging labeled for right-angle metal-tip cannulae.

    Product
    Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2995-2024·2024-09-18

    Medline cardiac and surgical procedure convenience kits recalled worldwide

    Medline Industries recalled cardiac and surgical procedure convenience kits distributed worldwide including pacemaker, angiography, and open heart surgery kits.

    Product
    Medline convenience kits labeled as: 1) PERMANENT PACING, Pack Number 00-400361J ; 2) NORTON CHILDRENS CATH LAB-LF, Pack Number 00-401185Q ; 3) PACEMAKER TRAY, Pack Number 00-401521F ; 4) FEMORAL PACK, Pack Number 00-401525G ; 5) CARDIAC CATH PACK , Pack Number 00-401561K ;
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3111-2024·2024-09-18

    Medline Suction Liners Recalled for Potential Loss of Suction

    Medline is recalling specific lots of semi-rigid suction liners due to potential loss of suction during clinical use. The recall affects convenience kits distributed to healthcare facilities in the US, Canada, and Panama.

    Product
    Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ENDO BRONCH PACK, Pack Number DYKE1355; b) ENDO BASIC KIT, Pack Number DYKE1356; c) ENDOSCOPY KIT, Pack Number DYKE1771C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3075-2024·2024-09-18

    SOL-CARE and SOL-M syringes recalled for unapproved design modifications

    Sol-Millennium Medical Inc. is recalling SOL-CARE and SOL-M syringes with safety needles because the devices are substantially different from FDA-cleared versions, with major modifications to intended use.

    Product
    Syringes with exchangeable needles labeled as: SOL-CARE: 1) SOL-CARE 10ml Luer Lock Syringe w/Safety Needle 21G*1 1/2 (needle aside), Model No. 102115SN, UPC 818392019858; 2) SOL-CARE 10ml Luer Lock Syringe w/Safety Needle 22G*1 1/2 (needle aside), Model No. 102215SN, UPC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2985-2024·2024-09-18

    Medline Convenience Kits Recalled Due to Plastic Syringe Quality Issues

    Medline is recalling specific convenience kits because they contain plastic syringes with leaks, breakage, or other quality issues that may pose a risk to patient health.

    Product
    Medline Convenience kits, labeled as: 1) DYNJ39451D , Pack Number HOOD PACK ; 2) DYNJ59573A , Pack Number ICU RESPIRATORY BRONCH PACK ; 3) DYNJ80281A , Pack Number OSC BRONCH PACK
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2998-2024·2024-09-18

    Medline surgical convenience kits recalled due to defective plastic syringes

    Medline is recalling multiple surgical and medical convenience kits containing plastic syringes affected by a safety alert. Leaks, breakage, and quality issues may affect patient safety during medical procedures.

    Product
    Medline Convenience kits labeled as: 1) BIOPSY PROCEDURE PACK, Pack Number 00-400162J; 2) BIOPSY PROCEDURE TRAY , Pack Number 00-400405C ; 3) BIOPSY DRAPE PACK , Pack Number 00-400762H ; 4) BIOPSY PROCEDURE PACK , Pack Number 00-400832N ; 5) BIOPSY PROCEDURE PACK , Pack Num
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3060-2024·2024-09-18

    Medline Medical Convenience Kits Recalled for Syringe Quality Issues

    Medline is recalling medical convenience kits that contain plastic syringes with potential leaks, breakage, and other quality issues that may pose risks to patient health.

    Product
    Medline Convenience kits, labeled as: 1) KNEE ARTHROSCOPY CDS-LF , Pack Number CDS983874F ; 2) HAND, Pack Number CDS984080F
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2988-2024·2024-09-18

    Medline Nerve Block Kits Recalled for Defective Plastic Syringes

    Medline is recalling nerve block convenience kits for defective plastic syringes that may leak or break, creating a patient safety risk during medical procedures.

    Product
    Medline Convenience kits, labeled as: 1) NERVE BLOCK TRAY-LF, Pack Number DYNJRA0377B; 2) PERIPHERAL NERVE BLOCK, Pack Number PAIN0137
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3114-2024·2024-09-18

    Medline semi-rigid suction liners recalled for potential suction loss

    Medline is recalling specific lots of semi-rigid suction liners from surgical convenience kits due to potential loss of suction during intermittent use. The recall affects approximately 3117 units distributed in the US, Canada, and Panama.

    Product
    Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ENDO KIT, Pack Number DYKE1092B; b) VIDEO BRONCHOSCOPY TRAY, Pack Number DYKE1666; c) SUCTION CANISTER KIT, Pack Number DYKM2196; d) SUCTION CANISTER KIT, Pack Number DYKM2196H; e) BRON
    Category
    Medical Device
    Distribution
    Distributed nationwide