PlainRecalls

2025 Recall Year Insight

Federal agencies issued 6,236 product recalls indexed by PlainRecalls in calendar year 2025. That represents about 5.97% of the 104,423 total recalls we track from 1995 through the present, and averages roughly 17.1 recalls per day across the FDA, CPSC, USDA FSIS, and NHTSA combined. Year-level views are the cleanest way to see macro patterns: volume spikes often correlate with new regulatory priorities (e.g., infant-sleep products after 2021, lithium-ion batteries after 2022), supply-chain contamination events, or changes in agency enforcement intensity, while quiet years can reflect either genuine product-safety improvements or reduced agency staffing and reporting lag. With 125 pages at 50 recalls each, browsing this year end-to-end gives a statistically representative sample of what the federal recall pipeline looked like in 2025.

On this page of 50 records, severity classification shows 8 critical, 38 moderate, and 4 lower-severity recalls. The page references 32 distinct recalling firms operating in 7 distinct product categories, with 48 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (25), FDA Drug (13), FDA Food (11), which matters because each agency's recall authority, hazard framing, and remedy mechanism differ, an FDA food recall, a CPSC consumer-product recall, and a NHTSA vehicle recall are legally distinct instruments even when the underlying hazard language sounds similar. Reviewing the dominant agency for a given year is one of the fastest ways to understand where federal attention was concentrated.

Year-indexed browsing serves three practical purposes: historical research (tracking how a hazard class evolved over time), consumer action (finding whether a product purchased in 2025 was later recalled), and journalistic or regulatory context (understanding what the enforcement landscape looked like in a given period). Every record on this page links to a full detail view with the hazard, remedy, distribution, and agency-assigned recall number, always use that recall number to verify current status directly with the issuing agency before acting on time-sensitive remedies, because agencies amend, terminate, and expand recalls in the months and years after initial publication. Data on this page reflects federal agency public filings; the agency's live record remains authoritative for legal, medical, or safety decisions. Verify with FDA openFDA, CPSC, USDA FSIS, or NHTSA for the system-of-record on any specific recall. PlainRecalls indexes this archive for research and consumer awareness purposes.

FDA Devices Moderate Dec 31, 2025

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509300 Software Version: N/A Product Description: Affixus 9 mm, Length 300 mm, Right, Trochanteric Nail Component: N/A

Zimmer, Inc.

FDA Devices Moderate Dec 31, 2025

Brand Name: Diasol Product Name: 100325-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters

Diasol, Inc

FDA Devices Moderate Dec 31, 2025

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609380 Software Version: N/A Product Description: Affixus 9 mm, Length 380 mm, Left, Trochanteric Nail Component: N/A

Zimmer, Inc.

FDA Devices Moderate Dec 31, 2025

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509320 Software Version: N/A Product Description: Affixus 9 mm, Length 320 mm, Right, Trochanteric Nail Component: N/A

Zimmer, Inc.

FDA Devices Moderate Dec 31, 2025

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609360 Software Version: N/A Product Description: Affixus 9 mm, Length 360 mm, Left, Trochanteric Nail Component: N/A

Zimmer, Inc.

FDA Devices Moderate Dec 31, 2025

BECKMAN COULTER BICARBONATE REF: OSR6137 OSR6237 OSR6637 OSR6x37 Bicarbonate is a system reagent for the quantitative determination of Bicarbonate in human serum and plasma on Beckman Coulter AU analyzers.

Beckman Coulter Ireland, Inc.

FDA Devices Moderate Dec 31, 2025

Ring Transjugular Intrahepatic Access Sets, Reference Part Numbers: 1) RTPS-100; 2) RTPS-100-10.0; The Ring Transjugular Intrahepatic Access Set is intended for transjugular liver access in diagnostic and interventional procedures.

Cook Incorporated

FDA Devices Moderate Dec 31, 2025

Brand Name: Diasol Product Name: 100125-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters

Diasol, Inc

FDA Devices Critical Dec 31, 2025

Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Numbers: 9903-20, 17188-04, 19762-03, 19203-04, 19203-04, 17957-10 Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalm

Alcon Research LLC

FDA Devices Critical Dec 31, 2025

Draeger Vapor 3000. Unheated, calibrated anesthetic vaporizer.

Draeger, Inc.

FDA Devices Moderate Dec 31, 2025

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509440 Software Version: N/A Product Description: Affixus 9 mm, Length 440 mm, Right, Trochanteric Nail Component: N/A

Zimmer, Inc.

FDA Devices Moderate Dec 31, 2025

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609400 Software Version: N/A Product Description: Affixus 9 mm, Length 400 mm, Left, Trochanteric Nail Component: N/A

Zimmer, Inc.

FDA Devices Moderate Dec 31, 2025

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609440 Software Version: N/A Product Description: Affixus 9 mm, Length 440 mm, Left, Trochanteric Nail Component: N/A

Zimmer, Inc.

FDA Devices Moderate Dec 31, 2025

Brand Name: Diasol Product Name: 100230-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters

Diasol, Inc

USDA FSIS Critical Dec 27, 2025

Mountain West Food Group, LLC Recalls Ground Beef Products Due To Possible E. Coli O26 Contamination

Mountain West Food Group LLC

FDA Food Moderate Dec 24, 2025

Celebration Herbals Senna Leaf Herbal Tea 24 Teabags, net wt. 1.48oz. UPC 628240201829

CELEBRATION HERBALS US

FDA Food Critical Dec 24, 2025

SENNA LEAVES F/C OG Item No: SEN15001 Net Wt: 44.75 Lbs Distributed By Whole Herb Company 19800 8th Street East, Sonoma, CA 95476 UPC 10031 44312

The Whole Herb Company, Inc.

FDA Food Moderate Dec 24, 2025

Pasteurized Donor Human Milk in 4 ounce/120 ml clear plastic bottles. The bottles have a foil seal and are capped with a green lid. Bottle size: 120ml

The New York Milk Bank, Inc.

FDA Food Critical Dec 24, 2025

Belevini BICHKI, Dried Salted Whole Smelts, Net. Weight, 5.29 oz (150 g) VACUUM PACK,20 PACKAGES PER CASE, FROZEN, REFRIGERATE AFTER OPENING

MAMTAKIM, Inc.

FDA Food Moderate Dec 24, 2025

Linzer Hearts Baked Cut Out Cookies UPC 0 44964 22072 2 72 - 4.0 oz Cut Cookies CBB-220-LZ Net Weight: 18 lbs Ingredients: Enriched flour (bleached WHEAT flowr, malted barley flour, niacin, iron, thaimine mononitrate, riboflavin, folic acid), butter (pasteurized cream (MILK), salt), granulated sugar, EGGS (whole EGGS, citric acid), raspberry filling (raspberries, corn syrup, sugar, water, contains 2% or less of the following, pectin, citric acid, guar gum, calcium chloride, potassium sorbate (pr

Dough-To-Go Inc

FDA Food Critical Dec 24, 2025

Food to Live brand ORGANIC MORINGA LEAF POWDER, packaged heat-sealed, resealable stand-up pouches in 8 oz, 1 lb., 2 lb., 4 lb., 8 lb., 16 lb., and 44 lb. bags; Ingredients: ORGANIC MORINGA LEAF POWDER; UPC: 8 oz - 840374833268 1 lb. - 840374812881 2 lb. - 840374813109 4 lb. - 840374810283 8 lb. - 840374833275 12 lb. - 840374812898 16 lb. - 840374812904 44 lb. - 840374833282

Lexunder Inc

FDA Food Critical Dec 24, 2025

Belevini KORUSHKA, Dried Salted Whole Smelts, Net. Weight, 5.29 oz (150 g) VACUUM PACK, 20 PACKAGES PER CASE, FROZEN, REFRIGERATE AFTER OPENING

MAMTAKIM, Inc.

FDA Food Moderate Dec 24, 2025

BaiLiFeng Dried Cinnamon Powder; Net Wt 4 oz/114G; Good Way Trading Group Inc 58-51 Maspeth Avenue Maspeth NY 11378; Product of China; Ingredients: Dried Cinnamon; UPC code: 4 897055 79940 1

Good Way Trading Group Inc

FDA Food Moderate Dec 24, 2025

Chef brand Milk Pan 24cm

Shata Traders Inc.

FDA Food Critical Dec 24, 2025

Food to Live brand ORGANIC SUPERGREENS POWDER MIX, packaged heat-sealed, resealable stand-up pouches in 8 oz, 1 lb., 1.5 lb., 3 lb., 6 lb., 12 lb.; Ingredients: ORGANIC KALE; ORGANIC MORINGA LEAF; ORGANIC WHEAT GRASS; ORGANIC SPIRULINA UPC: 8 oz. - 810097461475 1 lb. - 810097461482 1.5 lb. - 810097461499 3 lb. - 810097461505 6 lb. - 810097461512 12 lb. - 810097461529

Lexunder Inc

FDA Food Moderate Dec 24, 2025

Hollandia Dairy, Inc. 100% Appleberry Juice; Half Pint (236mL). UPC: 0 27495 03679 6

Hollandia Dairy, Inc.

FDA Drug Moderate Dec 24, 2025

Baclofen Tablets USP, 10 mg, 1000-count bottles, Rx only, Marketed by: GSMS, Incorporated, CA 93012 USA. NDC 51407-973-10

Golden State Medical Supply Inc.

FDA Drug Moderate Dec 24, 2025

Ciclopirox Shampoo, 1%, 120 mL, Rx only, Mfg by: Taro Pharmaceuticals Inc., Ontario, Canada; Dist. by: Taro Pharmaceuticals USA, Inc., NY 10532. NDC 51672-1351-08

SUN PHARMA /TARO

FDA Drug Low Dec 24, 2025

Cisatracurium Besylate Injection USP, 20 mg/10 mL*,(2 mg/mL), 10 x 10 mL Multiple-dose Vials per carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, 10mL Multiple-dose vial, NDC 70069-161-01; 10x10mL Multiple-dose vials per Carton, NDC 70069-161-01.

SOMERSET THERAPEUTICS LLC

FDA Drug Moderate Dec 24, 2025

Benco dental Graham CHEMICAL CO., Mepivacaine HCI 3% (30 mg/mL) Injection, [Mepivacaine HCI Injection, USP], packaged in a carton containing 50 single-dose Cartridges, 1.7 mL each, Rx only, Distributed by Benco Dental 295 Center Point Blvd, Pittston, PA 18640, Manufactured by Novocol Pharmaceutical of Canada, Inc., NDC 66975-406-51.

Novocol Pharmaceutical of Canada, Inc.

FDA Drug Moderate Dec 24, 2025

Ondansetron ODT Tablets, USP 4mg, 1x10 unit dose tablets, Mfg: Glenmark Pharmaceuticals Limited, Repackaged by Preferred Pharmaceuticals NDC 68788-8666-01

Preferred Pharmaceuticals, Inc.

FDA Drug Moderate Dec 24, 2025

darby dental supply, MEPIVACAINE, Mepivacaine HCI 3% (30mg/mL) Injection, [Mepivacaine HCI Injection, USP], packaged in a carton containing 50 single-dose Cartridges, 1.7 mL each, Rx only, Manufactured by Novocol Pharmaceutical of Canada, Inc., NDC 66467-9760-5.

Novocol Pharmaceutical of Canada, Inc.

FDA Drug Moderate Dec 24, 2025

3% Polocaine DENTAL, Mepivacaine Hydrochloride 3% (30mg/mL) (Mepivacaine HCI Injection, USP), packaged in a carton containing 50 single-dose Cartridges, 1.7 ml each, Rx only, Manufactured for Dentsply Pharmaceutical, York, PA 17404, by Novocol Pharmaceutical of Canada, Inc., NDC 66312-441-16.

Novocol Pharmaceutical of Canada, Inc.

FDA Drug Low Dec 24, 2025

Cisatracurium Besylate Injection USP, 200mg/20mL*(10mg/mL), 10 x 20 mL Single-dose Vials per Carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, Single dose 20mL vial NDC 70069-151-01; 10 x 20 Single dose vials per Carton, NDC 70069-151-10.

SOMERSET THERAPEUTICS LLC

FDA Drug Moderate Dec 24, 2025

2% Xylocaine DENTAL with Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton containing 50 single-dose cartridges, 1.7 mL each, Rx only, Manufactured for Dentsply Pharmaceutical, York, PA 17404, by Novocol Pharmaceutical of Canada, Inc., NDC 66312-176-16.

Novocol Pharmaceutical of Canada, Inc.

FDA Drug Moderate Dec 24, 2025

OraVerse, (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a carton containing 10 cartridges, 0.4 mg/1.7mL, Rx only, Made in Canada by Novocol Pharmaceutical of Canada, Inc., Distributed by Septodont, Inc., Louisville, Co, 80027, NDC 0362-0101-10

Novocol Pharmaceutical of Canada, Inc.

FDA Drug Low Dec 24, 2025

Cisatracurium Besylate Injection USP, 10 mg/5 mL* (2mg/mL), 10 x 5 mL Single-dose Vials per Carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, Single-dose 5 mL vial NDC 70069-141-01; 10x5 mL single dose vial per Carton NDC 70069-141-10.

SOMERSET THERAPEUTICS LLC

FDA Drug Moderate Dec 24, 2025

Cook-Walte, Carbocaine 3% (30 mg/mL), (mepivacaine hydrochloride Injection, USP), packaged in a carton containing 50 Single-Dose Cartridges, 1.7 mL, Rx only, Manufactured by Novocol Pharmaceutical of Canada, Inc., NDC 0362-0753-05.

Novocol Pharmaceutical of Canada, Inc.

FDA Drug Moderate Dec 24, 2025

Lidocaine HCI 2% and Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton containing 50 single-dose Cartridges, 1.7 ml each, Rx only, Manufactured for Patterson Dental Supply, Inc., 1031 Mendota Heights Road, Saint Paul, MN55120, Manufactured by: Novocol Pharmaceutical of Canada, Inc., NDC 50227-1030-5.

Novocol Pharmaceutical of Canada, Inc.

FDA Devices Moderate Dec 24, 2025

Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10

Cepheid

FDA Devices Moderate Dec 24, 2025

BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.

Smith & Nephew, Inc.

FDA Devices Low Dec 24, 2025

HemosIL SynthAFax. Partial Thromboplastin Time Tests.

Instrumentation Laboratory

FDA Devices Moderate Dec 24, 2025

Zimmer Air Dermatome, Model/Catalog Number: 00880100100

Zimmer Surgical Inc

FDA Devices Moderate Dec 24, 2025

Hardware configuration of the BeneVision Central Monitoring System (CMS), marketed as BeneVision Distributed Monitoring System (DMS). Model Number: 115-050935-00 and E115-050935-00. Software Version: Audio Driver version 6.0.9484.1 HP Pro Mini 400 G9 Desktop PC with Realtek HD Audio Driver Officially Released by HP (audio driver version 6.0.9484.1)

Mindray DS USA, Inc. dba Mindray North America

FDA Devices Moderate Dec 24, 2025

MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)

PATH

FDA Devices Moderate Dec 24, 2025

Myosa for Kids KS1 REF MyOSAKS1_Sb/Sp/Mb/Mp/Lb/Lc KS2 REF MyOSAKS2_Sb/Sc/Mb/Mc/Mp/Lb/Lc Myosa for Kids is a mouthguard in 3 different sizes (sm, med, lg) that can be used in children ages 3-15 to address breathing and myofunctional disorders. Catalog Numbers:

Myofunctional Research Company USA

FDA Devices Moderate Dec 24, 2025

Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20

Abbott Laboratories

FDA Devices Moderate Dec 24, 2025

Halyard, MIDTOWN GENERAL ARTERIOGRAM. Catalog Number: EUHM009-01.

AVID Medical, Inc.

FDA Devices Moderate Dec 24, 2025

Brand Name: Rocket Product Name: Rocket 16Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54549-16-PK Software Version: N/A Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pack to allow percutaneous insertion, supplied with connectors to allow attachment to chest drain bottle devices. Component: N/A

Rocket Medical Plc

FDA Devices Moderate Dec 24, 2025

GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system

GE Healthcare GmbH

Nearby Recall Years

Browse recalls from adjacent calendar years to see how federal enforcement volume has shifted over time.

Compare 2025 with 2024 →

Data Sources

  • Source: FDA openFDA Enforcement API - calendar-year recall filings for food, drugs, and devices
  • Source: USDA FSIS Recalls - calendar-year meat, poultry, and processed egg product recall filings
  • Source: CPSC + NHTSA - consumer product and vehicle recall feeds for 2025

Every figure on PlainRecalls is rendered directly from official FDA, CPSC, USDA FSIS and NHTSA recall records; no number is typed in by an editor. Figures cover calendar year 2025 across the FDA, CPSC, USDA FSIS and NHTSA federal recall feeds. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of September 2026.