PlainRecalls

2016 Recalls

6,806 recalls · Page 54 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 4 critical, 41 moderate, and 5 lower-severity recalls. The page references 27 distinct recalling firms operating in 5 distinct product categories, with 45 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (35), FDA Drug (11), FDA Food (4), 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 Moderate Aug 31, 2016

The Cheese & Berries Danish was labeled Pleasant Hill Ovens, Cheese Danish, Artificial Flavored, Net WT 5.0 OZ (142 g), UPC 7 63913 13003 4.

Northern Tier Bakery (dba\ Super Mom's)

FDA Food Moderate Aug 31, 2016

Oregon Sardines - Custom Smoked-NW Wild Products, 6.5 oz. metal cans. No UPC

Northwest Wild Products

FDA Food Moderate Aug 31, 2016

Pacific White Albacore Tuna - Custom Smoked -NW Wild Products, 6.5 oz. metal cans. No UPC

Northwest Wild Products

FDA Food Moderate Aug 31, 2016

Pacific Black Cod, NW Wild Products, 6.5 oz. metal cans. No UPC

Northwest Wild Products

FDA Drug Low Aug 31, 2016

Urea (50% Urea in a Cream Base), a) Net Wt. 5 oz (142 g), (NDC 42808-0200-05) b) Net Wt. 9 oz (225 g) (NDC 42808-0200-09), Rx Only, Manufactured in t…

Exact-Rx Inc

FDA Drug Moderate Aug 31, 2016

Human Chorionic Gonadotropin Injection (a) 2500 iu, (b) 2500 iu with B12, (c) 3500 iu, (d) 5000 iu, (e) 5000 iu with B12, (f) 6000 iu, (g) 7500 iu, (…

Talon Compounding Pharmacy

FDA Drug Low Aug 31, 2016

Acetasol HC (hydrocortisone and acetic acid otic solution USP) , Rx Only, 10 mL bottle, Manufactured by: Actavis Midatlantic LLC 1877 Kawai Road Linc…

Actavis Inc

FDA Drug Moderate Aug 31, 2016

Amlodipine Besylate Tablets, USP, 5 mg*, packaged in a) 100-count (10 x 10) unit dose blisters per carton, NDC 51079-451-20; b) 300-count (10 x 30) u…

Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

FDA Drug Moderate Aug 31, 2016

Sermorelin 6 mg and Sermorelin 6 mg/GHRP-2 Injection, 12 mg, 10 ml depyrogenated vials, Rx Only, Compounded by Talon Compounding Pharmacy, San Anton…

Talon Compounding Pharmacy

FDA Drug Moderate Aug 31, 2016

Amoxicillin for Oral Suspension USP, 400 mg/ 5 mL, 50 mL bottle, Rx only, Manufactured In Canada by: Teva Canada Limited, Toronto, Canada, NDC 0093-4…

Teva North America

FDA Drug Low Aug 31, 2016

Hydrocortisone and acetic acid otic solution, Rx only, 10 mL bottle, Distributed by Actavis Inc. 60 Columbia Road Bldg B. Morristown, NJ 07560 USA , …

Actavis Inc

FDA Drug Low Aug 31, 2016

Remeven Cream, (50% Urea in a Cream Base), a) 5.0 oz (142 g) and b) 9.0 oz (255 g) tubes, Rx only, Manufactured by Sonar Products Inc, Carlstadt, N…

Stratus Pharmaceuticals Inc

FDA Drug Moderate Aug 31, 2016

Amlodipine Besylate Tablets, USP, 10 mg*, packaged in a) 100-count (10 x 10) unit dose blisters per carton, NDC 51079-452-20; b) 300-count (10 x 30) …

Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

FDA Drug Low Aug 31, 2016

Desoximetasone Gel USP, 0.05%, packaged in 60 gram aluminum tubes, Rx only, Marketed by: VersaPharm Incorporated Marietta, GA 30062, Manufactured by…

Akorn, Inc.

FDA Drug Moderate Aug 31, 2016

Amlodipine Besylate Tablets, USP, 2.5 mg*, packaged in a)100-count (10 x 10) unit dose blisters per carton, NDC 51079-450-20 and b) 30-count tablets …

Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

FDA Devices Moderate Aug 31, 2016

TIBIAL TRAY , SIZE 5, REF 90-SRK-200500, QTY: 1, STERILE R, Responsive Orthopedics, total knee replacement

Medtronic Sofamor Danek USA Inc

FDA Devices Critical Aug 31, 2016

Alere INRatio PT/INR Test Strips Model Number: 0100071, 0100139 Product Usage: The INRatio/INRatio2 Test Strips perform a modified version of th…

Alere San Diego, Inc.

FDA Devices Moderate Aug 31, 2016

Ziehm Vision R, Mobile C-arm for Mobile Fluoroscopic Imaging

Ziehm Imaging Inc

FDA Devices Moderate Aug 31, 2016

TIBIAL TRAY , SIZE 2, REF 90-SRK-200200, QTY: 1, STERILE R, total knee replacement .

Medtronic Sofamor Danek USA Inc

FDA Devices Moderate Aug 31, 2016

TrueBeam¿ Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System, K140528. The TrueBeam and Edge Systems are intended to provide stereo…

Vision RT Ltd

FDA Devices Moderate Aug 31, 2016

Brilliance CT 16 Power, Model number 728240 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the bo…

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Aug 31, 2016

Ziehm Vision RFD 3D Mobile C-arm for Mobile Fluoroscopic Imaging

Ziehm Imaging Inc

FDA Devices Moderate Aug 31, 2016

Neff DAgostino Percutaneous Access Set Accessories, Catheter Intended for single-puncture percutaneous access to facilitate placement of an .038 in…

Cook Inc.

FDA Devices Moderate Aug 31, 2016

NovaPACS versions 8.4.7, 8.5.3, and 8.5.6. Distributed by Novarad Corporation. Picture archiving and communication system (PACS) Product Usage Nova…

Novarad Corporation

FDA Devices Critical Aug 31, 2016

Alere INRatio2 Replacement Monitor (Home) Model Number: 0200457 Product Usage: Alere INRatio 2 PT/INR Home Monitoring System: The Alere INRatio …

Alere San Diego, Inc.

FDA Devices Moderate Aug 31, 2016

Brilliance 64 CT Model number 728231 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by c…

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Aug 31, 2016

Ziehm Vision RFD Mot, Mobile C-arm for Mobile Fluoroscopic Imaging

Ziehm Imaging Inc

FDA Devices Moderate Aug 31, 2016

120 V Neptune 3 Rover, Model Number: 0703-001-000

Stryker Instruments Div. of Stryker Corporation

FDA Devices Moderate Aug 31, 2016

SOMATOM Definition AS with software version VA48A-SP2; Model # 10430603, computed tomography x-ray system

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Aug 31, 2016

Brilliance CT Big Bore Oncology, Model number 728243 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images …

Philips Medical Systems (Cleveland) Inc

FDA Devices Critical Aug 31, 2016

Alere INRatio2 PT/INR Professional Monitoring System Model Number: 55128A Product Usage: The Alere INRatio¿/INRatio¿2 system uses a modified ver…

Alere San Diego, Inc.

FDA Devices Moderate Aug 31, 2016

BVX-450NR Bovie Precise 360 Handpiece 45cm, needle Product is used for the delivery of helium gas plasma for cutting, coagulation, and ablation …

Bovie Medical Corporation

FDA Devices Moderate Aug 31, 2016

RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 5R, REF 90-SRK-311500, QTY: 1, STERILE R,

Medtronic Sofamor Danek USA Inc

FDA Devices Moderate Aug 31, 2016

Brilliance BigBore Radiology CT Model number 728244 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images o…

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Aug 31, 2016

Adult ThermoGard¿ Dual Dispersive Electrodes (for patients >15 kg.), 10' (3.05m) Cable, Catalog Number 51-7310. Intended to be used for the disper…

Conmed Corporation

FDA Devices Moderate Aug 31, 2016

Large QWIX Compression screw, dia. 7.5 mm L 90 mm, Lot No. FH86, Rx only, Product Usage: The QWIX Positioning screw is indicated for fixation of…

Integra LifeSciences Corp.

FDA Devices Moderate Aug 31, 2016

Aprima Access Nonvascular Introducer Set Accessories, Catheter Intended for single-puncture percutaneous access to facilitate placement of an .038 …

Cook Inc.

FDA Devices Moderate Aug 31, 2016

Shuttle Select Slip-Cath Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained an…

Cook Inc.

FDA Devices Moderate Aug 31, 2016

Radiesse (+) Lidocaine, Injectable Implant 1.5cc, Rx only, P/N: 8063M0K1, Merz Aesthetics. Product Usage: RADIESSE is indicated for sub-dermal im…

Merz North America, Inc.

FDA Devices Moderate Aug 31, 2016

Beacon Tip Royal Flush Plus High-Flow Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by…

Cook Inc.

FDA Devices Critical Aug 31, 2016

Alere INRatio/ INRatio2 PT/INR Test Strips Model Number: 99007EU, 99007G1, 99007G3, 99007G5, 99007G7, 99008EU, 99008G1, 99008G3, 99008G5, 99008G7 …

Alere San Diego, Inc.

FDA Devices Moderate Aug 31, 2016

RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.

Merge Healthcare, Inc.

FDA Devices Moderate Aug 31, 2016

OEC UroView 2800, fluoroscopic x-ray system

GE OEC Medical Systems, Inc

FDA Devices Moderate Aug 31, 2016

Conical portio adapter (acorn) small & large are used for examination and diagnosis in conjunction with endoscopic accessories in gynecological lapar…

Richard Wolf Medical Instruments Corp.

FDA Devices Moderate Aug 31, 2016

Panacea Air Pro Mattress Control Unit, Model: Platinum 5000, US Model Number 5000. Use with alternating pressure air flotation mattress.

American National Mfg Inc

FDA Devices Moderate Aug 31, 2016

BVX-330BR Bovie Precise 360 Handpiece 33cm, blade Product is used for the delivery of helium gas plasma for cutting, coagulation, and ablation o…

Bovie Medical Corporation

FDA Devices Moderate Aug 31, 2016

SUNRISE instrument. The INFINITE F50 instrument is a 96-well absorbance reader for the measurement of light absorbance (optical density) of liquid m…

Tecan US, Inc.

FDA Devices Moderate Aug 31, 2016

Pediatric ThermoGard¿ Dual Dispersive Electrodes (for patients 5-15 kg.), 10' (3.05m) Cable, Catalog Number 51-7710. Intended to be used for the d…

Conmed Corporation

FDA Devices Moderate Aug 31, 2016

Adult ThermoGard¿ Dual Dispersive Electrodes (for patients >15 kg.), No Cable, Catalog Number 51-7410. Intended to be used for the dispersion and …

Conmed Corporation

FDA Devices Moderate Aug 31, 2016

FluoroSet Radiographic Tubal Assessment Set Cannula, Manipulator/ Injector, Uterine Used for instillation of contrast media into the uterine cavity…

Cook 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