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

1726–1750 of 27375

HighFDA (Devices)·Z-0626-2026·2025-12-03
Caresite set 354207 recalled over backflow and priming occlusion
B. Braun Medical is recalling 381,850 Caresite primary gravity sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
Caresite utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. Primary Gravity Filtered Set with 2 CARE
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0699-2026·2025-12-03
IV set 490239 recalled over medication backflow between IV containers
B. Braun Medical is recalling 5,100 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET 103 IN.; Catal
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0632-2026·2025-12-03
Short extension sets recalled over piggyback backflow and occlusion
B. Braun Medical is recalling 13,600 extension sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. EXT SET W/ B/C VLV, ULTRAPORT, 57 I
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0657-2026·2025-12-03
IV set 490427 recalled over piggyback backflow and priming occlusion
B. Braun Medical is recalling 224,856 units iv administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/ 15 DROPS/ML
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0624-2026·2025-12-03
Caresite set 354204 recalled over piggyback backflow and priming occlusion
B. Braun Medical is recalling 12,225,913 units caresite sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
Caresite utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog numbers: 1. Primary Gravity IV Set with 2 CARESITE¿
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-0430-2026·2025-11-26
Infusion pump modules recalled because drops can damage the bezel assembly
CareFusion is recalling 2,574,396 BD Alaris Infusion Pump Modules 8100 because a dropped or jarred pump can suffer bezel damage causing under-infusion, over-infusion or unregulated flow.
Product
BD Alaris infusion Pump Module 8100, REF: 8100; KIT, BEZEL ASSY 8100BD, REF: 49000437; KIT ASSY ONE PIECE BEZEL 8100, REF: 49000270. Used with the following new and updated documents: BD Alaris Infusion System Inspection Safety Reminder, Part: BD-163124, Revision: 00; Clean
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0488-2026·2025-11-26
Jaw joint implants recalled over a discrepancy in screw hole position
TMJ Solutions is recalling 63 TMJ Bilateral Implants because the patient-fitted temporomandibular joint implant contained a discrepancy in screw hole position. The FDA classified it Class I.
Product
TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only
Category
Medical Device
Distribution
15 states
HighFDA (Devices)·Z-0526-2026·2025-11-26
Caesarean section kits recalled over smoke pencils that may activate
Medline is recalling 11,032 C-section convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.
Product
MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075W; 2) C-SECTION, REF CDS984261J; 3) C-SECTION CDS, REF CDS985282F; 4) C-SECTION PACK, REF DYNJ02577D; 5) C-SECTION PACK-LF, REF DYNJ0536924U; 6) C-SECTION PACK-LF, REF DYNJ0551169V; 7) C-SECT
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0541-2026·2025-11-26
Flow cytometers recalled over software that crashes during sample acquisition
Beckman Coulter is recalling 25 DxFLEX Flow Cytometers because a software error crashes the system during acquisition on a patient sample when running a customer defined protocol.
Product
DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 The DxFLEX Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping up to ten fluorescent detection channels using three lasers (488 nm, 638 nm and 405 nm) and two light s
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0515-2026·2025-11-26
Breast biopsy packs recalled over smoke pencils that may activate
Medline is recalling 301 breast biopsy and mastectomy convenience packs containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.
Product
MEDLINE convenience kits labeled as: 1) BREAST BIOPSY PACK-LF, REF DYNJ0160598C; 2) BIOPSY BREAST PACK, REF DYNJ65361A; 3) BREAST BIOPSY/MASTECTOMY, REF DYNJ908839A.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0540-2026·2025-11-26
Bone void implants recalled over an incorrect product name on packaging
Berkeley Advanced Biomaterials is recalling 62 Tribio Implants 7.5mm x 40mm because the outer packaging carries an incorrect product name.
Product
Tribio Implant 7.5mm x 40mm REF M80 SB008 UDI code: (01) 00816125023653(10) EBL10B13C(17) 270630 Tribio" Implant is indicated for use in bony voids or gaps of the skeletal system (i.e. extremities, pelvis and posterolateral spine). These osseous defects are surgically created
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0517-2026·2025-11-26
Laparotomy kits recalled over smoke pencils that may activate unprompted
Medline is recalling 28,679 laparotomy convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.
Product
MEDLINE convenience kits labeled as: 1) MAJOR LAPAROTOMY CDS, REF CDS860015W; 2) MAJOR LAPAROTOMY CDS, REF CDS860015X; 3) MINOR LAPAROTOMY CDS, REF CDS860016R; 4) MINOR LAPAROTOMY CDS, REF CDS860016S; 5) LAPAROTOMY CDS #31-RF, REF CDS860062S; 6) LAPAROSCOPY CDS, REF
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0527-2026·2025-11-26
Gynecology surgery kits recalled over smoke pencils that may activate
Medline is recalling 570 gynecology laparotomy, lithotomy and hysterectomy convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall by 47 lots.
Product
MEDLINE convenience kits labeled as: 1) GYN LAPAROTOMY HARPER PACK-LF, REF DYNJ0160684F; 2) MAJOR LITHOTOMY PACK-LF, REF DYNJ0425778O; 3) MINOR VAGINAL #76-RF, REF DYNJ27434R; 4) ABDOMINAL HYST PACK, REF DYNJ44848M; 5) DA VINCI HYSTERECTOMY, REF DYNJ44863Q; 6) VAGINA
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0521-2026·2025-11-26
General surgery and knee kits recalled over smoke pencil activation defect
Medline is recalling 20,941 general surgery, laparoscopy and total knee convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall by 47 lots.
Product
MEDLINE convenience kits labeled as: 1) GENERAL LAPAROSCOPY, REF CDS930027W; 2) GENERAL MAJOR CDS, REF CDS980245X; 3) BASIC GENERAL CDS, REF CDS980566F; 4) TOTAL KNEE CDS, REF CDS982823R; 5) BASIC CDS, REF CDS982936U; 6) UPPER EXTREMITY CDS, REF CDS983907M; 7) MAJO
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0511-2026·2025-11-26
Local basic kits recalled over smoke pencils that may stay active
Medline is recalling 48 LOCAL BASIC convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.
Product
MEDLINE convenience kits labeled as LOCAL BASIC, REF DYNJ34418M
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0525-2026·2025-11-26
Circumcision packs recalled over smoke pencils that may activate unprompted
Medline is recalling 120 Circumcision Pack convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.
Product
MEDLINE convenience kits labeled as: CIRCUMCISION PACK, REF DYNJ16826O
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0574-2026·2025-11-26
Reprocessed imaging catheters recalled after exceeding validated reprocessing cycles
Sterilmed is recalling four reprocessed ACUSON AcuNav diagnostic ultrasound catheters because they were reprocessed beyond validated cycles.
Product
Brand Name: Sterilmed Reprocessed Imaging Catheter Product Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR FOR USE WITH SIEMENS SYSTEM Model/Catalog Number: ACU10135936 Software Version: N/A Product Description: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR FOR US
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0504-2026·2025-11-26
Luer tip caps recalled after trays failed routine biocompatibility testing
Becton Dickinson is recalling 4,180,000 BD Luer Tip Caps after internal testing confirmed that certain device trays failed routine biocompatibility testing.
Product
BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0572-2026·2025-11-26
Nephrostomy balloon kits recalled after containing the wrong sized catheter
Olympus is recalling 60 Nephro-EZDilate nephrostomy balloon catheter kits because they contained a 4mm x 4cm urinary tract balloon instead of the correct 8mm x 15cm nephrostomy balloon.
Product
Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name: Olympus Nephro-EZDilate Nephrostomy Balloon Catheter Model/Catalog Number: BPCN0815K Product Description: The Nephro-EZDilate nephrostomy balloon catheter is a reinforced catheter attached
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-0542-2026·2025-11-26
Cell morphology analyzers recalled over barcodes read from the previous slide
Cellavision is recalling 688 DI-60 automated digital cell morphology analyzers because the barcode reader may read the previous slide's barcode, misattributing diagnostic results.
Product
REF: CC286297 or BS737162 Automated Digital Cell Morphology analyzer DI-60, IVD in conjunction with a Honeywell Vuquest or Jadk FM-5 barcode reader component.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0507-2026·2025-11-26
Heart pump implant kits recalled over corrosion at the battery connector
Thoratec is recalling 248 HeartMate II LVAS Implant Kits because potential corrosion at the backup battery cable connector may cause a Backup Battery Fault Alarm.
Product
Brand Name: HeartMate Product Name: HeartMate II¿ LVAS Implant Kit Model/Catalog Number: 106015, HeartMate II¿ LVAS Kit, with Pocket Controller, Sealed, US; 106016, HeartMate II¿ LVAS Kit, with Pocket Controller, Sealed, EU Software Version: N/A Product Description: The Heart
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0520-2026·2025-11-26
Basin packs recalled over smoke pencils that may activate unprompted
Medline is recalling 1,921 basin convenience packs containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.
Product
MEDLINE convenience kits labeled as: 1) MINOR SINGLE BASIN PACK, REF DYNJ37698L; 2) BASIN PACK, REF DYNJ50123D; 3) MAJOR BASIN PACK, REF DYNJ59816A; 4) OSC BASIN PACK, REF DYNJ68217A.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0512-2026·2025-11-26
Pacemaker packs recalled over smoke pencils that can remain active
Medline is recalling 12 Cath Lab Pacemaker Pack convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.
Product
MEDLINE convenience kits labeled as: CATH LAB PACEMAKER PACK, REF DYNJ59818A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0513-2026·2025-11-26
Vascular and open heart kits recalled over smoke pencils that may activate
Medline is recalling 5,133 vascular, carotid and open heart convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall by 47 lots.
Product
MEDLINE convenience kits labeled as: 1) GENERAL AAA #11-RF, REF CDS840261AB; 2) CAROTID ENDARTERECTOMY CDS-LF, REF CDS983637I; 3) PERIPHERAL VASCULAR CDS, REF CDS983723J; 4) ACH OPEN HEART, REF CDS983773J; 5) VASCULAR, REF CDS984255K; 6) OPEN HEART CHILDRENS PACK-LF,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0523-2026·2025-11-26
Major vaginal surgery packs recalled over smoke pencil activation defect
Medline is recalling 424 major vaginal surgery convenience packs containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.
Product
MEDLINE convenience kits labeled as: 1) MAJOR VAGINAL HARPER PACK-LF, REF DYNJ0161768G; 2) ACH MAJOR VAGINAL PACK, REF DYNJ67757B.
Category
Medical Device
Distribution
Distributed nationwide

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1726–1750 of 27375