Safety Recalls
RSS ↗15,259 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.
Showing 5,001–5,050 of 15,259
- Class II
Drug Recall · August 18, 2025
Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg, Double Strength, Rx Only, Packaged as a) 100-count bottle, NDC 65162-272-10; b) 500-count bottle, NDC 65162-272-50; Manufactured by: AmnealPresence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
- Class II
Medical Device Recall · August 18, 2025
CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 ¿mReviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.
- Class II
Medical Device Recall · August 18, 2025
AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R.Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."
- Class II
Medical Device Recall · August 18, 2025
ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Numbers (UPN) FPRCH8000, FPRCH8000-02, H749396118000Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
- Class II
Drug Recall · August 18, 2025
chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: AmnealPresence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
- Class I
Drug Recall · August 18, 2025
Lactated Ringers's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-07Presence of Particulate Matter
- Class II
Medical Device Recall · August 18, 2025
EverPatch+, REF: 1044002, Permanent Scleral Reinforcement Matrix 1x5.0mm x 8.5 mm Shield/1 x 5.0mm x 6.5 mm Rectangle, STERILE VH202Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.
- Class II
Food Recall · August 16, 2025
Panko Style Breaded Butterfly Shrimp (16/20 CT per pound) in bulk packaging, corrugated master cartons. Master carton case is NET WT 12 lbs. (192 OZ) 5.44 kg (4 x 3lbs cartons), Farm Raised Clean TailProduct may be contaminated with Cesium-137 (Cs-137)
- Class II
Food Recall · August 16, 2025
Clean-tail Coconut Farm Raise Breaded Butterfly Shrimp Clean Tail (21/25 CT per pound) in bulk packaging, corrugated master cartons. Master carton case (4 x 3lb), KEEP FROZEN. Product of Indonesia, ItProduct may be contaminated with Cesium-137 (Cs-137)
- Class II
Food Recall · August 16, 2025
ADMIRAL OF THE FLEET and PORTICO SEAFOOD CLASSIC (SYSCO) Cleantail Breaded Butterfly Shrimp (16/20 CT per pound) in bulk packaging, corrugated master cartons. Master carton case is NET WT 12 lbs. (192Product may be contaminated with Cesium-137 (Cs-137)
- Class II
Food Recall · August 15, 2025
Great Value branded and Sea Best branded raw frozen shrimp in bulk packaging, master cartons. Master carton case is 20 lbs (10 x 2lbs retail bags), and 18 lbs (12 x 1.5lbs retail bags) and (10x1lb reProduct may be contaminated with Cesium-137 (Cs-137)
- Class I
Food Recall · August 15, 2025
Organic Mango Freeze Dried Powder, Bulk, 15-kilogram boxes (2 packs of 7.5 kilograms in a carton box), 7.5kg packaged in multi-wall kraft paper boxes with inner food-grade polyethylene liner, Store inPotential Salmonella contamination
- Class II
Medical Device Recall · August 15, 2025
Exactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG PE 38MM HUM LINER +0/ 320-38-03,145-DEG PE 38MM HUM LINER +2.5/ 320-42-00,145-DEG PE 42MM HUM LINER +0/ 320-42-03,145-DEReverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.
- Class II
Medical Device Recall · August 15, 2025
Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder.Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis.
- Class II
- Class II
Medical Device Recall · August 15, 2025
STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device, SFX SPI PDS+ BI VIO 14X14IN(36X36CM) USP1(M4) D/A MO-4. Product Code: SXPP2B400-11.Potential for barb non-engagement.
- Class III
Food Recall · August 15, 2025
Stanley Pearlman Enterprises, Inc.
NAFCO, WHITING FILLET SKIN-ON BONELESS IQF, 2 lb., Cases are corrugate. The product is individually frozen and packed in food contact retail bag. 15 bags per case. Keep FrozenRecall initiated due to the wrong best by date (1-11-2025) being printed on the retail bag which would imply that these are expired but in truth they are good until 1-11-2027.
- Class II
Medical Device Recall · August 15, 2025
Heartstring III Proximal Seal System. Intravascular anastomosis occluder.Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis.
- Class II
Medical Device Recall · August 15, 2025
Exactech Equinoxe, Reverse Shoulder Humeral Liners, 322-38-00 (145-DEG PE 38MM HUM LINER +0), REF: 322-38-03 (145-DEG PE 38MM HUM LINER +2.5), REF:322-42-00 (145-DEG PE 42MM HUM LINER +0), REF: 3Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.
- Class II
Medical Device Recall · August 15, 2025
Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder.Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis.
- Class II
Medical Device Recall · August 15, 2025
Mindray DS USA, Inc. dba Mindray North America
BeneVision N1 Patient Monitor (N1). Part Numbers: 6660E-PA00017, 6660E-PA00014, 6660E-PA00012, 6660E-PA00011, 6660E-PA00018, 6660E-PA00015, 6660E-PA00020, Q6660E-PA00011, 6660E-PA00021, 6660E-PA00016,Potential for activation of an abnormal alarm pause.
- Unclassified
Consumer Product Recall · August 14, 2025
Werner Co., of Itasca, Illinois
Werner 20' and 24' Multi-Max Pro Multi-Purpose LaddersThe ladders' locking mechanism can jam and not fully lock into place, posing a fall hazard.
- Unclassified
Consumer Product Recall · August 14, 2025
Electronic LED modules used on Floating Stairs and RailsThe LED module can overheat, causing it to melt, posing a fire hazard.
- Class II
Food Recall · August 14, 2025
Admiralty Island Fisheries Inc dba AquaStar (USA) Corp.
Frozen AquaStar Breaded Shrimp, Butterfly, Clean-Tail, 16/20 count/lb. 3 lbs. package. Net wt. per case 36lbs. (12x3lbs. packages per case). UPC 731149601192. Packed For: AquaStar Seattle, WA. Farm RaProduct may be contaminated with Cesium-137 (Cs-137).
- Unclassified
Consumer Product Recall · August 14, 2025
Synergy Housewares LLC, of Coconut Creek, Florida
Wolfgang Puck Stainless Steel Petite Tea KettlesThe kettle's infuser basket lid is loose and can fall off during use, posing a burn hazard to consumers.
- Unclassified
Consumer Product Recall · August 14, 2025
IDrink Products Inc. dba Drinkmate, Inc., of Saline, Michigan
Drinkmate 1L Carbonation BottlesThe recalled Drinkmate 1L Carbonation Bottles can explode during use, posing serious impact, laceration and hearing damage hazards to users and bystanders.
- Class II
Food Recall · August 14, 2025
Admiralty Island Fisheries Inc dba AquaStar (USA) Corp.
AquaStar Cocktail Shrimp, 4oz. shrimp/2oz. cocktail sauce. Each case consists of 6x6 oz packages, UPC 19434612191. Distributed by Aqua Star, Seattle, WA. Farm Raised Product of Indonesia. Master casesProduct may be contaminated with Cesium-137 (Cs-137).
- Class II
Food Recall · August 14, 2025
Admiralty Island Fisheries Inc dba AquaStar (USA) Corp.
Frozen Mercado Kroger Cooked Shrimp - Medium - Peeled - Tail-Off - Shrimp Pieces. 2 lbs. package. Net wt. per case 10lbs. (5x2lb packages per case). UPC 011110626196.Product may be contaminated with Cesium-137 (Cs-137).
- Unclassified
Consumer Product Recall · August 14, 2025
Shantou Jinping District Wuqikong Daily Necessities Store, dba STWUQIKONG, of China
Children's Spiral Tower ToysThe recalled toy contains small balls and is intended for children under three years of age, which violates the small ball ban, posing a deadly choking hazard.
- Unclassified
Consumer Product Recall · August 14, 2025
Spectrum Brands Inc. for the benefit of Empower Brands, LLC, both of Middleton, Wisconsin
Hair Dryers sold under the "Remington" brand, model number D3190DCDNThe handheld hair dryers lack an immersion protection device, which presents a substantial product hazard to consumers, posing the risk of death or serious injury from electrocution or shock if the hair dryers fall into water while plugged in.
- Unclassified
Consumer Product Recall · August 14, 2025
ESR HaloLock Wireless Power BanksThe lithium-ion battery in the recalled power banks can overheat and ignite, posing fire and burn hazards to consumers.
- Unclassified
Consumer Product Recall · August 14, 2025
Firefly Fuels Inc., of Sarasota, Florida
Firefly Safe & Green 32 oz. Fuel BottlesThe recalled Safe & Green 32 oz. fuel bottles contain hydrocarbons, which must be in child-resistant packaging, as required by the Poison Prevention Packaging Act. The product includes a nozzle applicator which is not child-resistant, violating the mandatory standard. When the applicator is used instead of the child-resistant closure, it poses a deadly poisoning hazard to young children. Hydrocarbons can get into the lungs, causing chemical pneumonia and pulmonary damage, which can be fatal. In addition, the torch fuel violates the Federal Hazardous Substances Act because it is incorrectly labeled as "Non-Toxic".
- Class II
Drug Recall · August 13, 2025
Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension Rx Only, For Use in Ears Only, Manufactured By: Novartis Manufacturing NV, Belgium, Distributed by: Sandoz, Inc., Princeton, NJ, NDC# 0781-61Temperature Abuse
- Class II
Medical Device Recall · August 13, 2025
UniCel DxH 690T COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C34520Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.
- Class II
Medical Device Recall · August 13, 2025
Philips CT systems labeled as the following: 1. Big Bore RT, Model Number: 728242. 2. Brilliance CT Big Bore Oncology, Model Number: 728243. 3. Brilliance CT Big Bore, Model Number: 728244.The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
- Class III
Medical Device Recall · August 13, 2025
Penner Pacific Bathing Spa, Model Numbers 360020-1EPThe device does not bear a unique device identifier.
- Class II
Medical Device Recall · August 13, 2025
Philips CT systems labeled as the following: 1. Ingenuity CT 728326, Model Number: 728321. 2. Ingenuity CT 728326, Model Number: 728323. 3. Ingenuity CT, Model Number: 728326.The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
- Class II
Food Recall · August 13, 2025
Product Name: Blueberry Pretzels " Brand Name: HEB " Description: 8oz HEB Blueberry Flavored Yogurt Pretzels " UPC Codes: 9787011400 " Lot Numbers: 080226, 080326 " Best By / Use By Dates: 080226 & 08Undeclared wheat allergen.
- Class II
Medical Device Recall · August 13, 2025
CHANGE HEALTHCARE CANADA COMPANY
Change Healthcare Radiology Solutions software version 14.2.2Due to software issue, radiology reports may not be fully displayed when viewing.
- Class I
Food Recall · August 13, 2025
Chili Crunch Market Mezze; Keep Refrigerated, NET WT: 14.5 OZ, UPC# Manufactured by Fresh and Ready Foods LLC, San Fernando, CA 91340undeclared allergen (Wheat) on ready to eat sandwiches.
- Class I
Food Recall · August 13, 2025
Piccolo Pranzo Box; Keep Refrigerated, NET WT: 14.5 OZ, UPC# Manufactured by Fresh and Ready Foods LLC, San Fernando, CA 91340undeclared allergen (Wheat and Milk) on ready to eat sandwiches.
- Class II
Medical Device Recall · August 13, 2025
UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB Photometer REFs:B24802, 629029, B63322Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.
- Class III
Medical Device Recall · August 13, 2025
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, 370000-2WThe device does not bear a unique device identifier.
- Class III
Medical Device Recall · August 13, 2025
Penner Pacific Bathing Spa, Model Numbers 860010-1LThe device does not bear a unique device identifier.
- Class II
Medical Device Recall · August 13, 2025
iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Softwareit was found that in versions 1.3.7, 1.4.2, and 1.4.3, the Lock Screen and Limited Access Passcode Screen on the iLet graphical user interface (GUI) include certain icons displayed in the status bar that are active, thereby allowing the user to bypass those screens when those icons on the status bar are pressed, allowing unauthorized access while the device is in Limited Access Mode. A Health Risk associated with Limited access mode includes severe hypoglycemia due to unauthorized access to the iLet if someone were to make unauthorized meal announcements or stopped insulin delivery.
- Class III
Medical Device Recall · August 13, 2025
Penner Pacific Bathing Spa, Model Numbers 390010-1, 390010-X, 390010-2The device does not bear a unique device identifier.
- Class II
Medical Device Recall · August 13, 2025
Philips CT systems labeled as the following: 1. Brilliance iCT SP, Model Number: 728311.The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
- Class II
Medical Device Recall · August 13, 2025
Philips CT systems labeled as the following: 1. Brilliance 16 Power, Model Number: 728240. 2. Brilliance CT 16 Slice, Model Number: 728246. 3. Brilliance CT 6 Slice, Model Number: 728256.The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
- Class II
Medical Device Recall · August 13, 2025
Philips CT systems labeled as the following: 1. Ingenuity CT Family Brazil, Model Number: 728325.The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
- Class II
Medical Device Recall · August 13, 2025
UniCel DxH 600 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF:B23858Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.