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U.S. Food and Drug Administration

The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.

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1176–1200 of 26417

HighFDA (Devices)·Z-1513-2026·2026-03-18
Endo-Model SL Connection Component recalled for potential bushing fracture
Waldemar Link is recalling the Endo-Model SL Connection Component orthopedic implant due to potential detachment of the plateau screw bushing from the shaft caused by longitudinal fracture. The recall affects 49 units distributed worldwide.
Product
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1537-2026·2026-03-18
Lab analyzer cartridges may eject during warm-up, delaying results
Instrumentation Laboratory is recalling GEM Premier 5000 cartridges that may eject during warm-up due to Process Control Solution Not Detected errors, potentially delaying diagnostic results. The issue affects 253 units distributed worldwide.
Product
GEM Premier 5000; Part No. 00055430004.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1496-2026·2026-03-18
Syringe Recall: Luer Slip Syringes Incorrectly Packaged in Luer-Lok Batches
BD is recalling 204,000 units of 10mL non-sterile Luer-Lok syringes because Luer Slip syringes were mistakenly packaged in batches marked for Luer-Lok. The recall affects units distributed in California and Texas.
Product
10mL Non-Sterile BD Luer-Lok Tip Syringe Only. Catalog Number: 301029. 850 bulk non-sterile units per case.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1564-2026·2026-03-18
Medline Surgical Drapes Recalled Due to Premature Fabric Delamination
Medline Industries is recalling surgical drapes that may develop premature fabric delamination during laundering. This could delay patient care or allow surgical site contamination if the affected product is used.
Product
Medline Surgical Drapes: MDTBTCS6070GN DBD-DRAPE,COVER,TABLE,RESIS/XALT GRN,60X MDTBTCS6090GN DBD-DRAPE,COVER,TABLE,RESIS/XALT GRN,60X MDTDXUNDBGN DBD-DRAPE,UNDERBUTTOCK,28 X 50.5,XALT GR MDTMAYOXGN DBD-DRAPE,COVER,MAYO STAND,RESISTAT/XALT MDTZ1003656GN DBD-POCKET SHEET,RESISTAT
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1519-2026·2026-03-18
Endo-Model Replacement Plateau implant may experience bushing detachment from fracture
Waldemar Link is recalling Endo-Model Replacement Plateau implants because the bushing could detach from the screw shaft due to a longitudinal fracture. This mechanical failure could compromise the implant's integrity.
Product
Endo-Model Replacement Plateau; Item Number: 15-8521/11;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1518-2026·2026-03-18
Endo-Model Replacement Plateau implant screw bushing may detach
Waldemar Link's Endo-Model Replacement Plateau knee implant is recalled because the bushing on the plateau screw could detach due to longitudinal fracture. Eight units with specific lot numbers were distributed globally.
Product
Endo-Model Replacement Plateau; Item Number: 15-8521/09;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1559-2026·2026-03-18
Unapproved Wondfo Streptococcal A At-Home Self-Test Recalled by FDA
Wondfo Streptococcal A At-Home Self-Test has been recalled nationwide because the product was not cleared by the FDA. Consumers should discontinue use immediately.
Product
Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolytic streptococcal infection.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1543-2026·2026-03-18
Blood chemistry analyzer cartridges experience increased malfunction rate during warm-up
GEM Premier 5000 cartridges experience increased ejection errors during warm-up. The malfunction may delay test results and require manual cartridge replacement.
Product
GEM Premier 5000; Part No. 00055445010 & 00055445011.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1534-2026·2026-03-18
GEM Premier 5000 cartridges recalled for startup errors
Instrumentation Laboratory is recalling GEM PAK cartridges for the GEM Premier 5000 analyzer due to startup errors that may delay test results. The recall affects 195 units with 19 affected lot numbers.
Product
GEM Premier 5000; Part No. 00055415008.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1531-2026·2026-03-18
Blood gas analyzer cartridges recalled for warm-up ejection errors
Instrumentation Laboratory is recalling GEM Premier 5000 PAK cartridges due to increased Process Control Solution Not Detected errors during warm-up that may cause cartridge ejection and delay test results.
Product
GEM Premier 5000 PAK; Part No. 00055407511.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1532-2026·2026-03-18
Lab Analyzer Cartridges May Malfunction During Warm-Up Initialization
GEM Premier 5000 analyzer cartridges may experience increased malfunctions during warm-up initialization, causing ejection and requiring replacement. This may delay test results and operational continuity.
Product
GEM Premier 5000 PAK; Part No. 00055415004.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·H-0547-2026·2026-03-18
Vegetarian Chicken Flavor Ramen recalled for undeclared Yellow #5
Palmetto Gourmet Foods is recalling VEGETARIAN CHICKEN FLAVOR RAMEN Express (3oz packages) because it contains undeclared Yellow #5, an FDA-approved food colorant that must be labeled for consumers with sensitivities.
Product
VEGETARIAN CHICKEN FLAVOR RAMEN Express Net wt 3oz (85g) Ingredients: Enriched unbleached flour (wheat flour***) Vegetable oil***" Contains: Wheat, Soy. UPC 8 10037 81061 5 Produced by PALMETTO GOURMET FOODS, INC SALUDA, SC 29138
Category
Food
Distribution
32 states
ModerateFDA (Devices)·Z-1536-2026·2026-03-18
GEM Premier 5000 cartridges may experience detection failures during startup
Instrumentation Laboratory is recalling GEM PAK cartridges for the GEM Premier 5000 blood gas analyzer due to increased Process Control Solution Not Detected errors during warm-up, which may cause cartridge ejections and operational delays.
Product
GEM Premier 5000; Part No: 00055415011.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1495-2026·2026-03-18
Medline Unna-Z Stretch Zinc Paste Bandage Recalled for Incomplete Ingredient Labeling
Medline Unna-Z Stretch Zinc Paste Bandage (approximately 35,328 units) has been recalled due to incomplete ingredient labeling. The product label does not include castor oil and calamine.
Product
MEDLINE UNNA-Z STRETCH ZINC PASTE BANDAGE, REF NONUNNAS40 KOB article #40307010
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-1539-2026·2026-03-18
Medical Analyzer Cartridges May Fail Quality Control Detection During Startup
GEM Premier 5000 analyzer cartridges may fail quality control detection during startup, causing cartridge ejection and potential delays in laboratory test results. Approximately 1,607 units affected worldwide.
Product
GEM Premier 5000; Model No. 00055430010.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1499-2026·2026-03-18
Penner Pacific Bathing Spa Lacks Required Unique Device Identifier
Penner Patient Care is recalling 21 units of the Penner Pacific Bathing Spa due to missing unique device identifiers (UDI) required by regulations.
Product
Penner Pacific Bathing Spa, Model Numbers 350010-1, 350000-2, 350010-X
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1562-2026·2026-03-18
Medline Chest Drainage Units: Instructions Clarified for Adult Use Only
Medline is clarifying instructions for Aqua-Seal Chest Drainage Units to specify they are intended for adults 18 years and older. Approximately 2,894 units distributed worldwide are affected.
Product
Medline Kits containing Cardinal Health s Aqua-Seal Chest Drainage Unit: 1) OPEN HEART, Model Number: DYNJ902487A; 2) CARDIAC PROCEDURE, Model Number: DYNJ908126; 3) CARDIO CONGENITO, Model Number: DYNJ910851
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1526-2026·2026-03-18
GEM Premier 5000 Cartridges May Fail Quality Control Detection
GEM PAK cartridges for the GEM Premier 5000 analyzer may fail to detect process control solution during startup, causing cartridge rejection and potential delays in patient test results. No illnesses have been reported.
Product
GEM Premier 5000 PAK; Part No. 00055360010.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1527-2026·2026-03-18
GEM Premier 5000 PAK Laboratory Cartridges Recalled for Ejection Failures
GEM Premier 5000 PAK cartridges for laboratory testing equipment may experience increased ejection failures during warm-up, requiring frequent replacement and potentially delaying test results.
Product
GEM Premier 5000 PAK; Part No. 00055360011.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·H-0552-2026·2026-03-18
Lowes Foods sour cream and onion potato chips recalled for inaccurate nutrition
Uncle Ray's LLC is recalling Lowes Foods sour cream and onion flavored potato chips (8oz bags) due to inaccurate Nutrition Facts labels, including understated sodium content and undeclared monosodium glutamate.
Product
Lowes Foods sour cream and onion flavored potato chips, 8oz. bag, UPC 7 41643 05576 6, 9 retail units per case
Category
Food
Distribution
1 state
ModerateFDA (Devices)·Z-1530-2026·2026-03-18
GEM Premier 5000 PAK cartridges recalled for quality control errors
Instrumentation Laboratory recalls 1,126 GEM Premier 5000 PAK cartridges worldwide due to Process Control Solution Not Detected (PCSND) errors during warm-up that cause cartridge ejection and test delays. No illnesses or injuries reported.
Product
GEM Premier 5000 PAK; Part No. 00055407510.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1561-2026·2026-03-18
Bisaf Strep A Self-Test recalled; product not FDA cleared
Altruan GmbH is recalling the Bisaf Strep A Self-Test because the product was distributed without FDA clearance. This diagnostic test is used to detect Group A Streptococcal antigens in throat swabs.
Product
Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1541-2026·2026-03-18
GEM Premier 5000 Cartridge Malfunction May Delay Lab Results
GEM PAK cartridges in the GEM Premier 5000 may eject repeatedly during warm-up, causing operational delays. Affected cartridges will be replaced.
Product
GEM Premier 5000; Part No. 00055445004.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1528-2026·2026-03-18
GEM Premier 5000 PAK cartridges: process control detection errors recall
Instrumentation Laboratory is recalling 489 units of GEM Premier 5000 PAK lab cartridges that may experience increased process control solution detection errors during warm-up, potentially delaying patient test results.
Product
GEM Premier 5000 PAK; Part No. 00055407504.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1500-2026·2026-03-18
Penner Pacific Bathing Spa Recalled for Missing Device Identifier
Penner Patient Care, Inc. is recalling Penner Pacific Bathing Spa units nationwide because they lack a unique device identifier required by FDA regulations. The recall affects 643 units.
Product
Penner Pacific Bathing Spa, Model Numbers 360010-2WT, 360010-1, 370000-1W, 360010-1WT, 362010-1, 370000-1WL, 360010-1L, 360010-1W, 360010-XWTL, 370000-XWL, 360010-1WTL, 360010-XWT, 360010-2, 370000-2W, 360010-2L, 370000-2WL, 360010-X, 370000-XW, 360010-2W, 362010-2, 360010, 37000
Category
Medical Device
Distribution
Distributed nationwide