PlainRecalls

2016 Recalls

6,806 recalls · Page 95 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, 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 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 11 critical, 39 moderate, and 0 lower-severity recalls. The page references 20 distinct recalling firms operating in 7 distinct product categories, with 44 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (31), FDA Drug (7), CPSC (6), 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, or NHTSA for the system-of-record on any specific recall. PlainRecalls indexes this archive for research and consumer awareness purposes.

FDA Drug Moderate May 18, 2016

Repaskin 50 (octocrylene 7%, titanium oxide 2%) Facial Sunscreen gel cream, Broad Spectrum SPF 50, 1.7 fl oz (50 mL) tube, over the counter, Manufact…

Sesderma, SL

FDA Drug Moderate May 18, 2016

Salises Facial Moisturizing Acne Treatment Gel, (salicylic acid 1.5%), 1.7 fl. oz (50 mL) bottle, over the counter, Manufactured by Sesderma S.L., Va…

Sesderma, SL

FDA Drug Moderate May 18, 2016

Brevibloc DOUBLE STRENGTH Premixed Injection, Esmolol Hydrochloride in Sodium Chloride, 2000mg/100mL (20 mg/mL), 100 mL, Rx only, Manufactured by Bax…

Baxter Healthcare Corp.

FDA Drug Moderate May 18, 2016

Repaskin 30 (octacrylene 4%, oxybenzone 3%, octisalate 3%, octinoxate 3% Avobenzone 3%) Body Lotion Sunscreen gel cream, Broad Spectrum SPF 30, 6.8 f…

Sesderma, SL

FDA Drug Moderate May 18, 2016

Screenses Color Sunscreen Tinted facial make-up compact, Broad Spectrum SPF 50, Brown, 0.35 oz (10 g), Manufactured by Sesderma S.L., Valencia, Spain…

Sesderma, SL

FDA Drug Moderate May 18, 2016

Repaskin 30 (octacrylene 4%, oxybenzone 3%, octisalate 3%, octinoxate 3% Avobenzone 3%) Facial Sunscreen gel cream, Broad Spectrum SPF 30, 1.7 fl oz …

Sesderma, SL

FDA Drug Moderate May 18, 2016

Dryses Aluminum Chlorohydrate Deodorant for Women, Roll-on, 2.5 fl oz (75 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spai…

Sesderma, SL

FDA Devices Critical May 18, 2016

Vitek 2 Gram Positive Susceptibility Test Cards (AST-P640 REF 418579), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility C…

Biomerieux Inc

FDA Devices Moderate May 18, 2016

Ellipse ICD (Implantable Cardioverter Defibrillator) Model CD2411-36Q, CD2411-36C, CD1411-36Q, CD1411-36C Product Usage: Ellipse ICD devices are …

St Jude Medical Inc.

FDA Devices Moderate May 18, 2016

Dimension Vista Blood Urea Nitrogen (BUN) Flex reagent cartridge The BUN method is an in vitro diagnostic test for the quantitative measurement of…

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate May 18, 2016

Dimension Assays: Triglycerides (TGL)

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate May 18, 2016

Distal Femoral Replacement (patient specific, custom made orthopedic implant device). PIN 19960

Stanmore Implants Worldwide Ltd.

FDA Devices Moderate May 18, 2016

ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA Chemistry Glucose & Concentrated Glucose Oxidase Assay and ADVIA Chemistry Glucose.

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate May 18, 2016

Dimension clinical chemistry system, Sirolimus (SIRO) Flex reagent cartridge (DF306 SMN 10464331) Lot EB6064, Open Well Instability The SIRO metho…

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate May 18, 2016

GEM(TM), FLOWCOUPLER(R), 2.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2753-FC. Product Usage: The FlowCOUPLER Device is a single use, impla…

Baxter Healthcare Corp.

FDA Devices Moderate May 18, 2016

Dimension Assays: ENZYMATIC CREATININE

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate May 18, 2016

Given Imaging Bravo¿ pH capsule delivery device, 5-pack. In-Vitro Diagnostic for pH monitoring of gastric reflux Item Number: FGS-0312 The Bravo…

Covidien LLC

FDA Devices Critical May 18, 2016

Battery Pack Used with the Capnostream"20 and Capnostream"20p Patient Monitor, Battery Packs Model Number - 016400, 010520. Battery Pack used with t…

Medtronic

FDA Devices Critical May 18, 2016

Vitek 2 Gram Positive Susceptibility Test Cards (AST-P645 REF 419602), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Car…

Biomerieux Inc

FDA Devices Critical May 18, 2016

Vitek 2 Gram Positive Susceptibility Test Cards (AST-P639 REF 418662), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Ca…

Biomerieux Inc

FDA Devices Moderate May 18, 2016

Dimension Assays: Direct HDL Cholesterol (AHDL)

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate May 18, 2016

CinchLock SS Knotless Anchor with Inserter; Model number CAT02462; Orthopedic: The Pivot CinchLock SS Knotless Anchor (CAT02462) and Pivot Cinc…

Stryker Corporation

FDA Devices Moderate May 18, 2016

Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 Used to rotate implant into position

Atlas Spine, Inc.

FDA Devices Moderate May 18, 2016

Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. Distrib…

Applied Medical Resources Corp

FDA Devices Moderate May 18, 2016

Dimension Vista Assays: Triglycerides (TRIG)

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate May 18, 2016

Ascom Mobile Monitoring Gateway (versions 4.1.1 and 4.2.0) and Ascom Unite Connect for Nurse Call (version 2.2.0).

Ascom US, INC.

FDA Devices Critical May 18, 2016

Vitek 2 Gram Positive Susceptibility Test Cards (AST-P644 REF 418673), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Car…

Biomerieux Inc

FDA Devices Critical May 18, 2016

Vitek 2 Gram Positive Susceptibility Test Cards (AST-P642 REF 418604), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Car…

Biomerieux Inc

FDA Devices Moderate May 18, 2016

ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT & ADVIA CHEMISTRY TRIGLYCERIDES_2 Concentrated (TRIG_c) REAGENT

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate May 18, 2016

GEM(TM), FLOWCOUPLER(R), 2.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2752-FC Product Usage: The FlowCOUPLER Device is a single use, implan…

Baxter Healthcare Corp.

FDA Devices Moderate May 18, 2016

GEM(TM), FLOWCOUPLER(R), 3.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2754-FC Product Usage: The FlowCOUPLER Device is a single use, implan…

Baxter Healthcare Corp.

FDA Devices Moderate May 18, 2016

Given Imaging Bravo¿¿ pH capsule delivery device, 1-pack. In- Vitor Diagnostic for pH monitoring of gastric reflux Item Number: FGS-0313 The Bra…

Covidien LLC

FDA Devices Moderate May 18, 2016

Dimension Vista Assays: Direct HDL Cholesterol (AHDL)

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate May 18, 2016

Dimension Vista Assays: Uric Acid (URCA)

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate May 18, 2016

Advia Chemistry Assay: Direct HDL Cholesterol (D-HDL)

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate May 18, 2016

NovaPACS  Diagnostic Viewer versions 8.3.7, 8.4.2, 8.4.3, and 8.4.4. Novarad Corporation

Novarad Corporation

FDA Devices Moderate May 18, 2016

Advia Chemistry Assay: Uric Acid and Uric Acid, concentrated

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate May 18, 2016

GEM(TM), FLOWCOUPLER(R), 3.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2755-FC Product Usage: The FlowCOUPLER Device is a single use, implanta…

Baxter Healthcare Corp.

CPSC Moderate May 18, 2016

phil&teds Recalls Dash Strollers Due to Risk of Injury

phil&teds, of Fort Collins, Colo.

CPSC Moderate May 17, 2016

Pacific Cycle Recalls Infant Bicycle Helmets Due to Choking and Magnet Ingestion Hazards; Sold Exclusively at Target

CPSC Moderate May 17, 2016

Target Recalls Menorahs Due to Fire Hazard

NHTSA Critical May 17, 2016

KIA 2013: SEAT BELTS:FRONT:RETRACTOR

KIA

NHTSA Critical May 17, 2016

BMW 2011: POWER TRAIN:DRIVELINE:DRIVESHAFT

BMW

NHTSA Critical May 17, 2016

MERCEDES-BENZ 2016: POWER TRAIN:DRIVELINE:DRIVESHAFT

MERCEDES-BENZ

NHTSA Critical May 16, 2016

FIAT 2013-2016: ELECTRICAL SYSTEM:PROPULSION SYSTEM:TRACTION BATTERY

FIAT

NHTSA Critical May 16, 2016

FIAT 2012-2016: POWER TRAIN:MANUAL TRANSMISSION

FIAT

NHTSA Moderate May 16, 2016

CHRYSLER,DODGE 2016: SEATS:MID/REAR ASSEMBLY

CHRYSLER,DODGE

CPSC Moderate May 12, 2016

Hobby Lobby Recalls Infant Pacifier Holders Due to Choking Hazard

CPSC Moderate May 12, 2016

Hobby Lobby Recalls Infant Rattles Due to Choking Hazard

CPSC Moderate May 12, 2016

Kubota Recalls Utility Vehicles Due to Injury and Collision Hazards (Recall Alert)

Kubota Tractor Corporation, of Torrance, Calif.

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 — consumer product and vehicle recall feeds for 2016