Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

4351–4375 of 27375

SevereFDA (Devices)·Z-3088-2024·2024-09-18
Smiths Medical BLUperc tracheostomy tubes recalled for pilot balloon disconnection
Smiths Medical is recalling BLUperc and BLUselect tracheostomy tube kits worldwide due to a manufacturing defect that could cause the pilot balloon to disconnect from the inflation line, potentially compromising airway management.
Product
smiths medical portex BLUperc Percutaneous Diliation Procedural Trays with BLUselect tracheostomy tubes, labeled as follows: 1) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 7.0 mm BLUselect trach tube, Item Number 101/561/070; 2) BLUperc Percuta
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-3053-2024·2024-09-18
Medline Convenience Kits Recalled Due to Syringe Quality Issues
Medline is recalling C Scope Disposable Kits because they contain plastic syringes affected by a March 2024 FDA Safety Alert regarding leaks and breakage.
Product
Medline Convenience kits labeled as: 1) C SCOPE DISPOSABLE KIT, Pack Code 613034700; 2) C SCOPE DISPOSABLE KIT, Pack Code 613034701; 3) C SCOPE DISPOSABLE KIT, Pack Code 613034702
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-3113-2024·2024-09-18
Medline Recalls Semi-Rigid Suction Liners Due to Suction Loss
Medline is recalling specific lots of semi-rigid suction liners due to reported adverse events involving potential loss of suction during use.
Product
Medline convenience kits containing semi-rigid suction liners labeled as follows: a) MINOR BREAST, Pack Number DYNJ908104B; b) PLASTIC MAJOR, Pack Number DYNJ908106B; c) ABDOMINOPLASTY W/LIPO SUCTION, Pack Number DYNJ909946; d) PLASTIC, Pack Number DYNJ909951
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-3108-2024·2024-09-18
Medline Recalls Semi-Rigid Suction Liners Due to Suction Loss
Medline Industries is recalling 19 units of semi-rigid suction liners due to reported adverse events involving potential loss of suction during use.
Product
Medline convenience kits containing semi-rigid suction liners labeled as follows: DENTAL, Pack Number DYNJ909451A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2991-2024·2024-09-18
Medline Cardiac Pacing Kits Recalled for Syringe Quality Issues
Medline is recalling cardiac pacing kits containing plastic syringes with leaks or breakage risks. The recall addresses quality issues that may pose a risk to patient health.
Product
Medline Convenience kits labeled as: CARDIAC PACING PACK, Pack Number DYNJ41223
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3005-2024·2024-09-18
Medline Medical Convenience Kits Recalled Due to Syringe Quality Issues
Medline is recalling specific medical convenience kits because they contain plastic syringes affected by a March 2024 FDA Safety Alert regarding leaks and breakage.
Product
Medline Convenience kits labeled as: 1) URETEROSCOPY CDS SC-LF, Pack Number CDS983922F ; 2) URETEROSCOPY TRAY-RF, Pack Number DYNJ27442U ; 3) URETHROPLASTY PACK, Pack Number DYNJ39700B ; 4) RRP PACK, Pack Number DYNJ44109B ; 5) PROSTATECTOMY PACK-LF , Pack Number DYNJ6
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3018-2024·2024-09-18
Medline Convenience Kits Recalled Due to Plastic Syringe Quality Issues
Medline is recalling convenience kits containing plastic syringes affected by an 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) GER ARTH BASIN PK RFID-LF , Pack Number DYNJ0100999K ; 2) PEDIATRIC MAJOR BASIN PACK-LF , Pack Number DYNJ0154061C ; 3) EYE BASIN PACK-LF , Pack Number DYNJ0259872M ; 4) EYE BASIN PACK-LF , Pack Number DYNJ0259872MH; 5) BASIN DBL PACK
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3101-2024·2024-09-18
Siemens Atellica IM CA 19-9 Assay Recalled for Positive Bias
Siemens Healthcare Diagnostics is recalling Atellica IM CA 19-9 kits due to positive bias in some samples, particularly in the Asia Pacific population.
Product
Atellica IM 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:10995489
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3123-2024·2024-09-18
BioFire FILMARRAY TORCH Module Recall Due to Calibration Errors
BioFire is recalling FILMARRAY TORCH modules because calibration errors may cause false positive or negative results for pathogens like Salmonella and MRSA.
Product
FILMARRAY TORCH MODULE BOX, HTFA-ASY-0003, HTFA-ASY-0003-W, HTFA-ASY-0003U
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3004-2024·2024-09-18
Medline Medical Convenience Kits Recalled Due to Syringe Quality Issues
Medline is recalling medical convenience kits containing plastic syringes affected by an 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) FETOSCOPY CDS-LF, Pack Number CDS840215O ; 2) BONE RETRIEVAL PART A , Pack Number CDS981237F ; 3) BASIC BIOPSY TRAY , Pack Number DYNDA1217A ; 4) ONCOLOGY PORT ACCESS TRAY , Pack Number DYNDC2239; 5) US BREAST BIOPSY TRAY, Pack N
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3124-2024·2024-09-18
Blood Pressure Module Fails to Record or Alarm in Hemodialysis Machines
Fresenius hemodialysis machines with BPM3 blood pressure modules may fail to record measurements and will not alarm if cuff tubing is kinked. About 3,718 affected units in the US and Canada could result in undetected blood pressure changes during treatment.
Product
Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware version S005 installed in 2008 Series Hemodialysis Machines with Part Numbers 190573, 190713, 190766, 190858, 190895, 190908, 191124, 191126, 191128, and 191130
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3016-2024·2024-09-18
Medline Medical Convenience Kits Recalled Due to Plastic Syringe Quality Issues
Medline Industries is recalling medical convenience kits containing plastic syringes affected by an 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) CHEST EXPLORATION CDS , Pack Number CDS920066K ; 2) CHEST EXPLORATION CDS , Pack Number CDS920066L ; 3) PLASTIC SMR CDS-LF, Pack Number CDS980088K ; 4) PLASTICS, Pack Number CDS980200AA; 5) PLASTICS, Pack Number CDS980200Y ; 6) BREAS
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3046-2024·2024-09-18
Medline Medical Convenience Kits Recalled Due to Plastic Syringe Quality Issues
Medline is recalling specific medical convenience kits because they contain plastic syringes affected by an 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) LAVH CDS, Pack Number CDS760049AB; 2) TUBAL LIGATION CDS, Pack Number CDS760053D ; 3) TUBAL LIGATION CDS, Pack Number CDS760053G ; 4) TUBAL LIGATION CDS, Pack Number CDS760053I ; 5) TUBAL LIGATION CDS, Pack Number CDS760053J ; 6) GYN
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3028-2024·2024-09-18
Medline Medical Convenience Kits Recalled Due to Plastic Syringe Defects
Medline is recalling medical convenience kits containing plastic syringes affected by an FDA Safety Alert due to leaks, breakage, and other quality issues.
Product
Medline Convenience kits labeled as: 1) KIT GENERAL CLOSURE , Pack Number DYKMBNDL200A ; 2) KIT GENERAL CLOSURE , Pack Number DYKMBNDL200AH; 3) CUST CHEST TUBE INSERTION X , Pack Number DYNDA2415B ; 4) LACERATION TRAY , Pack Number DYNDL1495A ; 5) LACERATION TRAY , Pac
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3096-2024·2024-09-18
Smith & Nephew Recalls Rotation Medical Tendon Staples Due to Seal Defects
Smith & Nephew is recalling Rotation Medical Tendon Staples because packaging defects may compromise sterility. The recall affects 6,465 units distributed worldwide.
Product
ROTATION MEDICAL TENDON STAPLES (8) (broad indication)-Intended for fixation of prosthetic material to soft tissues. Product Number: 2504-1
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3061-2024·2024-09-18
Medline Burn Packs Recalled Due to Syringe Quality Issues
Medline is recalling burn convenience kits because they contain plastic syringes with leaks or breakage risks identified in an FDA Safety Alert.
Product
Medline Convenience kits, labeled as: aa1) BURN PACK-LF, Pack Number DYNJ0781678S ; 2) BURN PACK , Pack Number DYNJ0976092P ; 3) BURN PACK-LF, Pack Number DYNJ42829B ; 4) BURN PACK , Pack Number DYNJ54386C ; 5) LARGE BURN PACK , Pack Number DYNJ69770; 6) LARGE BURN
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2981-2024·2024-09-18
Medline Medical Convenience Kits With Defective Syringes Recalled Worldwide
Medline recalled medical convenience kits containing plastic syringes with leaks, breakage, and quality defects. The affected syringes may pose a risk to patient health.
Product
Medline Convenience kits, labeled as: 1) TRACHEOTOMY TRAY, Pack Number DYNDA1894; 2) ULTRASOUND GUIDED PIV KIT, Pack Number MNS9580;
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3117-2024·2024-09-18
Medline Suction Liners Recalled Due to Potential Suction Loss
Medline Industries is recalling 134 units of semi-rigid suction liners due to potential loss of suction during intermittent use. The affected kits were distributed worldwide including the US, Canada, and Panama.
Product
Medline convenience kits containing semi-rigid suction liners labeled as follows: KIT NEURO SHUNT ST LOUIS CHILD, Pack Number DYNJ907829B
Category
Medical Device
Distribution
Distributed nationwide
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-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-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-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-3023-2024·2024-09-18
Medline Convenience Kits with Plastic Syringes Recalled for Leaks and Breakage
Medline Convenience kits with plastic syringes affected by an FDA safety alert are being recalled due to leaks, breakage, and quality issues that may harm patients.
Product
Medline Convenience kits labeled as: 1) CENTRAL LINE CDS, Pack Number CDS930092U ; 2) SMALL WOUND TRAY, Pack Number DYNDA1822; 3) RADIOLOGY UTILITY TRAY, Pack Number DYNDA2865; 4) BLOOD CULTURE SET , Pack Number DYNDH1495A ; 5) LACERATION TRAY , Pack Number DYNDL1050; 6) L
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-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

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4351–4375 of 27375