All recalls
- 2026-03-18FDA-DeviceWaldemar Link GmbH & Co. KG (Mfg Site)Class IIEndo-Model Replacement Plateau; Item Number: 15-8521/11;
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
- 2026-03-18FDA-DeviceWaldemar Link GmbH & Co. KG (Mfg Site)Class IIEndo-Model Replacement Plateau; Item Number: 15-8521/09;
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
- 2026-03-18FDA-DeviceWaldemar Link GmbH & Co. KG (Mfg Site)Class IIEndo-Model Replacement Plateau; Item Number: 15-8030/12;
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
- 2026-03-18FDA-DeviceWaldemar Link GmbH & Co. KG (Mfg Site)Class IIEndo-Model Replacement Plateau; Item Number: 15-2836/11;
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
- 2026-03-18FDA-DeviceWaldemar Link GmbH & Co. KG (Mfg Site)Class IIEndo-Model Replacement Plateau; Item Number: 15-2835/12;
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
- 2026-03-18FDA-DeviceWaldemar Link GmbH & Co. KG (Mfg Site)Class IIEndo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
- 2026-03-18FDA-DeviceWaldemar Link GmbH & Co. KG (Mfg Site)Class IIEndo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
- 2026-03-18FDA-DeviceWaldemar Link GmbH & Co. KG (Mfg Site)Class IIEndo-Model Replacement Plateau; Item Number: 15-0027/15;
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
- 2026-03-18FDA-DeviceWaldemar Link GmbH & Co. KG (Mfg Site)Class IIEndo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
- 2026-03-18FDA-DeviceExactech, Inc.Class IIBrand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number: KIT-311X
Impactor handle may be missing cross-pin
- 2026-03-18FDA-DeviceExactech, Inc.Class IIBrand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05
Impactor handle may be missing cross-pin
- 2026-03-18FDA-DevicePenner Patient Care, Inc.Class IIIPenner Pacific Bathing Spa, Model Numbers 860010-1L
The device does not bear a unique device identifier.
- 2026-03-18FDA-DevicePenner Patient Care, Inc.Class IIIPenner Pacific Bathing Spa, Model Numbers 760010-1, 770010-1
The device does not bear a unique device identifier.
- 2026-03-18FDA-DevicePenner Patient Care, Inc.Class IIIPenner Pacific Bathing Spa, Model Numbers 560010-2L, 560010-XL, 560010-1L, 560010-XL
The device does not bear a unique device identifier.
- 2026-03-18FDA-DevicePenner Patient Care, Inc.Class IIIPenner Pacific Bathing Spa, Model Numbers 390010-1, 390010-X, 390010-2
The device does not bear a unique device identifier.
- 2026-03-18FDA-DevicePenner Patient Care, Inc.Class IIIPenner Pacific Bathing Spa, Model Numbers 361910-1A, 361910-1A, 361910-XA, 361910-2I, 361910-1A, 361910-1, 361910-XI, 361910-1I, 361910-2A, 36191-1A, 361910-X
The device does not bear a unique device identifier.
- 2026-03-18FDA-DevicePenner Patient Care, Inc.Class IIIPenner Pacific Bathing Spa, Model Numbers 360030-1C, 360030-1CE, 360030-1CTS, 360030-XCE, 360030-XC, 360030-1CT, 360030-1C, 360030-XC, 360030-XCT, 360030-1CTS, 360030-XCTS, 3600301-CTS, 360030-XCE, 360030-1CT, 360030-1CE, 36030-XCT
The device does not bear a unique device identifier.
- 2026-03-18FDA-DevicePenner Patient Care, Inc.Class IIIPenner Pacific Bathing Spa, Model Numbers 360020-1P
The device does not bear a unique device identifier.
- 2026-03-18FDA-DevicePenner Patient Care, Inc.Class IIIPenner Pacific Bathing Spa, Model Numbers 360020-1EP
The device does not bear a unique device identifier.
- 2026-03-18FDA-DevicePenner Patient Care, Inc.Class IIIPenner 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-XWL, 362010-X, 362010-XL, 362010-1L, 360010-XL, 37000-1W, 360010-XW, 3700000-1W, 362010-2L, 36010-XWT, 370000-1L, 360010-2WT, 360000-1, 360010-XWSB, 360010-XLSB
The device does not bear a unique device identifier.
- 2026-03-18FDA-DevicePenner Patient Care, Inc.Class IIIPenner Pacific Bathing Spa, Model Numbers 350010-1, 350000-2, 350010-X
The device does not bear a unique device identifier.
- 2026-03-18FDA-DeviceRaz Design IncClass IIRaz-AT (Attendant Tilt) Mobile Shower Commode Chair, Catalog Number Z300 UDI-DI code: (01)00628758003007 Raz-ART (Attendant Rotational Tilt) Mobile Shower Commode Chair, Catalog Number Z333 UDI-DI code: (01)00628758003335 Raz-AT600 (Bariatric Tilt) Mobile Shower Commode Chair, Catalog Number Z360 UDI-DI code: (01)00628758003601 Raz-SP (Self Propel) Mobile Shower Commode Chair, Catalog Number Z200 UDI-DI code: (01)00628758001003 Raz-AP (Attendant Propel) Mobile Shower Commode Chai
Due to a modification by a vendor and may be reinstalled without properly engaging the outside rear seat brackets that are used to keep the seat in place.
- 2026-03-18FDA-DeviceIon Beam Applications S.A.Class IIIBA Proton Therapy System - PROTEUS 235
It was identified that eh Universal Beam Triggering Interface (UBTI) is disabled in the Therapy Safety System (TSS) configuration. In this condition, the TSS does not interrupt the beam delivery if the Healthy Signal from an external gating device is lost. This may lead to a risk of mistreatment when external gating devices are used.
- 2026-03-18FDA-DeviceBecton Dickinson & CompanyClass II10mL Non-Sterile BD Luer-Lok Tip Syringe Only. Catalog Number: 301029. 850 bulk non-sterile units per case.
During the bulk packaging process, some Luer Slip syringes were incorrectly included in a batch designated for Luer Lok syringes.
- 2026-03-18FDA-DeviceKOB GmbHClass IIMEDLINE UNNA-Z STRETCH ZINC PASTE BANDAGE, REF NONUNNAS40 KOB article #40307010
Due to labeling error. Incomplete ingredients listed. Labeling did not include castor oil or calamine.
- 2026-03-18FDA-FoodHouse Of Flavors, Inc.Class IHouse of Flavors 4893 Chicago Vanilla Naturally Flavored Ice Cream, 3 GAL tub
Undeclared egg
- 2026-03-18FDA-FoodCNC Noodle CorporationClass IISecondary Packaging: ZHONG HUA CHAO MIAN NOODLE INGREDIENTS: ENRICHED FLOUR, WATER, STARCH, SALT, POTASSIUM, CARBONATE AND BENZOATE OF SODA ADDED AS PRESERVATIVE F.D. & C. YELLOW COLOR #5 & #5 (TARTRAZINE) ARTIFICIAL COLORS) Primary Packaging: CHINA NOODLE CO. FRESH NOODLE NET WEIGHT 10 LBS. (4536 grams) PERISHABLE KEEP REFRIGERATED INGREDIENTS: ENRICHED WHEAT FLOUR (BLEACHED WHEAT FLOUR, NIACIN, IRON, ASCORBIC ACID, THIAMIN MONONITRATE, RIBOFLAVIN), WATER, SALT, SODIUM BI-CARBONATE, 1/1000 BEN
Undeclared wheat and Yellow #6.
- 2026-03-18FDA-FoodCNC Noodle CorporationClass IISecondary Packaging: STEAM NOODLES INGREDIENTS: ENRICHED FLOUR, WATER, STARCH, SALT, POTASSIUM, CARBONATE AND BENZOATE OF SODA ADDED AS PRESERVATIVEM F.D. & C. YELLOW COLOR #5 & #6 (TARTRAZINE) ARTIFICIAL COLORS) Primary Packaging: CHINA NOODLE CO. STEAM NOODLE NET WEIGHT 10 LBS. (4536 grams) PERISHABLE KEEP REFRIGERATED INGREDIENTS: ENRICHED WHEAT FLOUR (BLEACHED WHEAT FLOUR, NIACIN, IRON, ASCORBIC ACID, THIAMIN MONONITRATE, RIBOFLAVIN), WATER, SALT, SOYBEAN OIL, SODIUM BI-CARBONATE, 1/1000 BE
Undeclared wheat.
- 2026-03-18FDA-FoodMade Fresh Salads IncClass IMade Fresh Salads brand Tofu Whipped; 5 lb white plastic tub
Products may be contaminated with Listeria monocytogenes.
- 2026-03-18FDA-FoodMade Fresh Salads IncClass IMade Fresh Salads brand Whipped Cream Cheese; 5 lb white plastic tub
Products may be contaminated with Listeria monocytogenes.