PlainRecalls

2016 Recalls

6,806 recalls · Page 12 of 137

2016 Recall Year Insight

Federal agencies issued 6,806 product recalls indexed by PlainRecalls in calendar year 2016. That represents about 8.11% of the 83,949 total recalls we track from 1995 through the present, and averages roughly 18.6 recalls per day across the FDA, CPSC, NHTSA, and USDA FSIS 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 137 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 2016.

On this page of 50 records, severity classification shows 7 critical, 39 moderate, and 4 lower-severity recalls. The page references 23 distinct recalling firms operating in 5 distinct product categories, with 48 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (21), FDA Drug (15), FDA Food (14), 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 2016 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, NHTSA, or USDA FSIS for the system-of-record on any specific recall. PlainRecalls indexes this archive for research and consumer awareness purposes.

FDA Food Critical Dec 7, 2016

Nor-Tech Dairy Sharp White Cheddar Feather Shred Cheese, 5 lb. packages packed in plastic bags, keep refrigerated

Kuster's Inc.

FDA Food Critical Dec 7, 2016

Kuster's Dairy Foods Sliced Colby JackCheese, 5 lb. packages packed in plastic bags, keep refrigerated

Kuster's Inc.

FDA Food Moderate Dec 7, 2016

Arrowhead/Christmas Tree Shells; Best If Used By 02/26/2017; Batch 162734737; NET WT 12 Pounds; Approximate Unit Count [Per Case]: 8 Dozen [96 units]

Mel-O Cream Donuts International, Inc.

FDA Food Moderate Dec 7, 2016

ISLAND SOUPS, RED PEAS SOUP NO MEAT, NET WT. 16 OZ (28.4G)

Island Soups Company Inc.

FDA Food Moderate Dec 7, 2016

ISLAND SOUPS, RED PEAS SOUP, NET WT. 16 OZ (28.4G)

Island Soups Company Inc.

FDA Food Critical Dec 7, 2016

A New Dairy Pepper Jack cut Cheese, 5 lb. packages packed in plastic bags, keep refrigerated

Kuster's Inc.

FDA Food Moderate Dec 7, 2016

Hy Vee Shells (Bavarian Filled); Best If Used By 02/25/2017; Batch 162724703; NET WT 26.48 Pounds; Approximate Unit Count: 84 units

Mel-O Cream Donuts International, Inc.

FDA Food Moderate Dec 7, 2016

Jumbo Pershing (Cinnamon) Rolls; NET WT 11.25 and 16.1 Pounds; Approximate Unit Count [Per Case]: 6-8 Dozen; Brands: Mel-O-Cream and Hy-Vee

Mel-O Cream Donuts International, Inc.

FDA Food Moderate Dec 7, 2016

Hy Vee Long Johns (Red Raspberry Filled); Best If Used By 02/25/2017; Batch 162724690; NET WT 14.63 Pounds; Approximate Unit Count: 72 units

Mel-O Cream Donuts International, Inc.

FDA Food Moderate Dec 7, 2016

ISLAND SOUPS, GUNGO PEAS SOUP, NET WT. 16 OZ (28.4G)

Island Soups Company Inc.

FDA Food Critical Dec 7, 2016

Fata's Best Four Blend Feather Shred Shredded Cheese, 5 lb. packages packed in plastic bags, keep refrigerated

Kuster's Inc.

FDA Food Moderate Dec 7, 2016

Chocolate Sea Salt Probiotic Granola, Purely Elizabeth, 8oz, PET/LLDPE Pouch, 6 units/case,

purely elizabeth.

FDA Food Critical Dec 7, 2016

A New Dairy PepperJack 3/4" Cubed Cheese, 5 lb. packages packed in plastic bags, keep refrigerated

Kuster's Inc.

FDA Food Critical Dec 7, 2016

Kuster's Dairy Foods Three Blend Shredded Cheese, 5 lb. packages packed in plastic bags, keep refrigerated

Kuster's Inc.

FDA Drug Moderate Dec 7, 2016

Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey 08…

Nationwide Laboratories, LLC

FDA Drug Moderate Dec 7, 2016

Travoprost Ophthalmic Solution USP, 0.004%, a) 2.5 mL and b) 5 mL bottles, Rx only, FOR USE IN THE EYES ONLY, Made in India, Distributed by: Par Phar…

Par Pharmaceutical, Inc.

FDA Drug Moderate Dec 7, 2016

Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals, Inc., Richland, MS --- NDC 3…

Burel Pharmaceuticals Inc

FDA Drug Moderate Dec 7, 2016

AZUPHEN MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 120 mg, Monobasic Sodium Phosphate 40.8 mg, Phenyl Salicylate 36 mg, Meth…

Burel Pharmaceuticals Inc

FDA Drug Moderate Dec 7, 2016

Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals, Inc., Richland, MS --- NDC 3…

Burel Pharmaceuticals Inc

FDA Drug Moderate Dec 7, 2016

Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey 08…

Nationwide Laboratories, LLC

FDA Drug Moderate Dec 7, 2016

URAMIT MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 118 mg, Monobasic Sodium Phosphate 40.8 mg, Phenyl Salicylate 36 mg, Methy…

Burel Pharmaceuticals Inc

FDA Drug Moderate Dec 7, 2016

Ondansetron HCI API, Bulk, Manufacturer: Cadila Pharmaceuticals, Ltd., Ankleshwar, Gujarat, India 393002

Cadila Pharmaceuticals Limited

FDA Drug Moderate Dec 7, 2016

Hyolev MB URINARY ANTISEPTIC Tablets, Each tablet for oral administration contains: Hyoscyamine Sulfate 0.12 mg, Methenamine 81 mg, Methylene Blue 10…

Burel Pharmaceuticals Inc

FDA Drug Moderate Dec 7, 2016

Indiomin MB URINARY ANTISEPTIC, ANTISPASMODIC Capsules, Each capsule contains: Methenamine 120 mg, Monobasic Sodium Phosphate 40.8 mg, Methylene Blu…

Burel Pharmaceuticals Inc

FDA Drug Moderate Dec 7, 2016

Salsalate Tablets, USP, 500 mg, packaged in a) 500 count bottles (NDC 42937-703-18); b) 100 count bottles (NDC 42937-703-10); and c) 1000 count bottl…

Nationwide Laboratories, LLC

FDA Drug Moderate Dec 7, 2016

Metformin Hydrochloride Tablets, USP 500 mg, 1000 tablets, Rx Only Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed b…

Ascend Laboratories LLC

FDA Drug Moderate Dec 7, 2016

UROPHEN MB URINARY ANTISEPTIC Tablets, Each tablet contains: Methenamine 81.6 mg, Benzoic Acid 9.0 mg, Phenyl Salicylate 36 mg, Methylene Blue 10.8 …

Burel Pharmaceuticals Inc

FDA Drug Moderate Dec 7, 2016

Salsalate Tablets, USP, 750 mg, packaged in a) 100 count bottles (NDC 42937-704-10); b) 500 count bottles (NDC 42937-704-18); and c) 1000 count bottl…

Nationwide Laboratories, LLC

FDA Drug Moderate Dec 7, 2016

UROLET MB URINARY ANTISEPTIC, ANTISPASMODIC Tablets, Each tablet contains: Methenamine 81.6 mg, Monobasic Sodium Phosphate 40.8 mg, Phenyl Salicylat…

Burel Pharmaceuticals Inc

FDA Devices Moderate Dec 7, 2016

ARROW OnControl Bone Marrow Biopsy System Tray, Sterile, Rx only, Manufactured for: Teleflex Medical, The Arrow OnControl Bone Marrow Aspiration S…

Teleflex Medical

FDA Devices Moderate Dec 7, 2016

Z6Ms transesophageal transducers used on ACUSON SC2000 ultrasound systems, Z6Ms model 10436113. Radiology: The ACUSON SC2000 ultrasound imaging s…

Siemens Medical Solutions USA, Inc.

FDA Devices Low Dec 7, 2016

Dynasty Liners: REF DLCOGA28, REF DLCOGB32, REF DLCOGC36, REF DLCOGD38, REF DLCOGE40, REF DLCOGF42, REF DLCOGG44, REF DLCOGH48, REF DLCOGJ52, REF DL…

MicroPort Orthopedics Inc.

FDA Devices Critical Dec 7, 2016

Greatbatch, Offset Cup Impactor with the following Parts and Catalogue #: Tl0600 ~ MMP3100CHA04 T10491 MIMP3100CHA04 T12230 M2M1P3100CHA04 T1575…

Greatbatch Medical

FDA Devices Moderate Dec 7, 2016

Sterile IV Start Kits 50 units/trays per case Convenience kit for IV start procedures

B. Braun Medical, Inc.

FDA Devices Low Dec 7, 2016

Cobalt Chromium Heads Transcend: 26000017, 26000018, 26000019, 26000020, 26000021, 26000022, 26000023, 26000024, 26000025, 26000026, 26000027, 2600…

MicroPort Orthopedics Inc.

FDA Devices Moderate Dec 7, 2016

Merge FlexConnect software, a component of Merge LIS. Merge FlexConnect is middleware used in conjunction with Merge LIS to facilitate connection to…

Merge Healthcare, Inc.

FDA Devices Moderate Dec 7, 2016

Adiprep Adipose Transfer System. Product Codes: 51431; 51432; 51433; 514001-347.

Terumo BCT, Inc.

FDA Devices Moderate Dec 7, 2016

Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm Stop/44.5 mm Non-Sterile

Synthes (USA) Products LLC

FDA Devices Low Dec 7, 2016

Procotyl (Rim- Lock) Liners: REF PHA04702, REF PHA04704, REF PHA04706, REF PHA04708, REF PHA04710, REF PHA04712, REF PHA04714 For use with the cons…

MicroPort Orthopedics Inc.

FDA Devices Moderate Dec 7, 2016

FMsealer Open Shears. Model FM3001

Domain Surgical, Inc.

FDA Devices Moderate Dec 7, 2016

ARROW OnControl Bone Lesion Biopsy System Tray, Sterile, Rx only, The Arrow OnControl Bone Lesion Biopsy System is intended for bone biopsy of the v…

Teleflex Medical

FDA Devices Moderate Dec 7, 2016

MSS CASSETTE GLU/LAC/UREA (BUN) as a part of the Roche OMNI S Analyzer: cobas b 221<6>Roche OMNI S6 system The Roche Diagnostics Omni S Analyzer is…

Roche Diagnostics Operations, Inc.

FDA Devices Moderate Dec 7, 2016

Bridge Occlusion Balloon. Model: 590-001 Temporary vessel occlusion of the superior vena cava in applications including perioperative occlusion and …

Spectranetics Corporation

FDA Devices Moderate Dec 7, 2016

Hamilton-MR1 Ventilator: Catalog# 161010 The Hamilton MR1 Ventilator is intended to provide pressure ventilator support to adults and pediatrics, a…

Hamilton Medical, Inc.

FDA Devices Moderate Dec 7, 2016

OnControl Biopsy System Ported Needle Tray, Sterile, Rx only, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiratio…

Teleflex Medical

FDA Devices Moderate Dec 7, 2016

Turbo Elite Atherectomy Catheter. Models: 410-152, 410-154, 414-151, 414-159, 417-152, 417-156, 420-006, 420-159, 423-001, 423-135-01 The Laser Cath…

Spectranetics Corporation

FDA Devices Moderate Dec 7, 2016

ConforMIS iTotal Cruciate Retaining (CR) Knee Replacement System, Sterile Catalog Number: TCR-111-1111. Intended for use as a total knee replacem…

ConforMIS, Inc.

FDA Devices Moderate Dec 7, 2016

Monaco TRP System The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy.

Elekta, Inc.

FDA Devices Moderate Dec 7, 2016

Monaco RTP System; Used to make treatment plans for patients with prescriptions for external beam radiation therapy.

Elekta, Inc.

FDA Devices Low Dec 7, 2016

Conserve Cups: REF 38BF3642, REF 38BF3642SP, REF 38BF3844, REF 38BF3844SP, REF 38BF4046, REF 38BF4046SP, REF 38BF4248, REF 38BF4248SP, REF 38BF4450,…

MicroPort Orthopedics Inc.

Nearby Recall Years

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

Compare 2016 with 2015 →

Data Sources

  • Source: FDA openFDA Enforcement API — calendar-year recall filings for food, drugs, and devices
  • Source: CPSC + NHTSA + USDA FSIS — consumer product, vehicle, and meat/poultry recall feeds for 2016