PlainRecalls

2016 Recalls

6,806 recalls · Page 88 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 0 critical, 46 moderate, and 4 lower-severity recalls. The page references 26 distinct recalling firms operating in 3 distinct product categories, with 50 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (40), FDA Drug (9), CPSC (1), 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 Drug Low Jun 8, 2016

Ceftriaxone Sodium (Sterile) USP active pharmaceutical ingredient, DMF No. 15931; Manufactured by: Lupin Limited, Unit-1, 198-202, New Industrial Are…

Lupin Pharmaceuticals Inc.

FDA Drug Moderate Jun 8, 2016

Sulfacetamide Sodium Ophthalmic Solution, USP, 10%, Sterile, Rx Only, 15 mL bottles, Mfd. by: Akorn, Inc., Lake Forest, IL 60045 --- NDC 17478-221-12

Akorn, Inc.

FDA Drug Moderate Jun 8, 2016

Dobutamine 2000 mcg/mL in a) D5W-500 mL, b) D5W-750 mL, c) D5W-1000 mL, d) D5W-1750 mL Bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy …

Baptist Health Medical Towers Pharmacy and Infusion Services

FDA Drug Moderate Jun 8, 2016

Ceftriaxone 2 gram in 100 mL 0.9% NS bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR

Baptist Health Medical Towers Pharmacy and Infusion Services

FDA Drug Moderate Jun 8, 2016

D5 1/2 NS 1000 mL with Electrolytes bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR

Baptist Health Medical Towers Pharmacy and Infusion Services

FDA Drug Low Jun 8, 2016

Ceftriaxone for Injection USP, 250 mg, Single Use Vial, packaged in a) 1-count Vials per box (NDC 68180-611-01), and b) 10-count Vials per box (NDC 6…

Lupin Pharmaceuticals Inc.

FDA Drug Moderate Jun 8, 2016

Deferoxamine 3300 mg/20 mL Sterile Water for Injection syringe, FOR SUBCUTANEOUS USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little …

Baptist Health Medical Towers Pharmacy and Infusion Services

FDA Drug Moderate Jun 8, 2016

Vancomycin 2 grams in 540 mL 0.9% NS bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR

Baptist Health Medical Towers Pharmacy and Infusion Services

FDA Drug Low Jun 8, 2016

¿Topicort (desoximetasone) Cream USP, 0.05%, Packaged in 5 g Tubes, Professional Sample Only, Rx Only. Mfd. by: Taro Pharmaceuticals Inc., Brampton, …

Taro Pharmaceuticals U.S.A., Inc.

FDA Devices Moderate Jun 8, 2016

Vistec X-Ray Detectable Sponges, 16 Ply, 8" x 4" (20.3 cm x 10.2 cm) Item Number: 7319

Covidien LLC

FDA Devices Moderate Jun 8, 2016

Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 12" x 12" (30.5 cm x 30.5 cm) Item Number:6534

Covidien LLC

FDA Devices Moderate Jun 8, 2016

COSEAL Surgical Sealant Kit, 4 mL, Product Code: 934071; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealin…

Baxter Healthcare Corp

FDA Devices Moderate Jun 8, 2016

COSEAL Surgical Sealant Kit, 8 mL, Product Code: 934072; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealin…

Baxter Healthcare Corp

FDA Devices Moderate Jun 8, 2016

Non-Vented Dispensing Pin with One-Way Valve and Luer Lock Ultrasite Valve Product Usage: Used for aspiration of medication from inverted bags or…

B. Braun Medical, Inc.

FDA Devices Moderate Jun 8, 2016

The ARCHITECT Estradiol Kit Intended to measure estradiol, an estrogenic steroid, in plasma.

Abbott Laboratories

FDA Devices Moderate Jun 8, 2016

Curity All Purpose Sponges, Non-woven, 4 Ply, Soft Pouch, 4" x 4" (10.2 cm x 10.2 cm) Item Number: 8047

Covidien LLC

FDA Devices Moderate Jun 8, 2016

EZ Slide Battery/line powered hydraulic table with removable leg section and 21 top slide General Purpose Surgical Table Skytron EZ Slide Opera…

Skytron, Div. The KMW Group, Inc

FDA Devices Moderate Jun 8, 2016

Laparotomy Pack Latex Free, part number 007725-7. This is a custom convenience surgical instrument disposable kit. There are multiple component…

Windstone Medical Packaging, Inc.

FDA Devices Low Jun 8, 2016

CytoScan¿ Dx Assay. The CytoScan Dx Assay consists of five reagent modules, wash buffers (WS), a microarray kit, and analysis software. The CytoScan…

Affymetrix Inc

FDA Devices Moderate Jun 8, 2016

Novation Press-Fit Tapered, Standard Offset, 12/14 Taper, Size 14, Femoral Stem, Catalog Number 160-00-14; For use in primary total hip arthroplasty.

Exactech, Inc.

FDA Devices Moderate Jun 8, 2016

Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 56mm, O.D. (Acetabular Cup), Catalog Number 140-01-56; For use in primary total hip arthrop…

Exactech, Inc.

FDA Devices Moderate Jun 8, 2016

Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments

Integra LifeSciences Corp.

FDA Devices Moderate Jun 8, 2016

Dimension Vista 500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V.3.6.2, Device listing # D011374, All serial numbers and lot…

Siemens Healthcare Diagnostics Inc.

FDA Devices Moderate Jun 8, 2016

Curity X-Ray Detectable Laparotomy Sponges, Tray Pack, 8" x 36" (20.3 cm x 91.4 cm Item Number: 6056

Covidien LLC

FDA Devices Moderate Jun 8, 2016

Vistec X-Ray Detectable Sponges, 26 Ply, 8" x 4" (20.3 cm x 10.2 cm) Item Number: 7321

Covidien LLC

FDA Devices Moderate Jun 8, 2016

Endoscope ED-250XL5 Operations Manual: Cleaning, Disinfection

Fujifilm Medical Systems U.S.A., Inc.

FDA Devices Moderate Jun 8, 2016

Torque Limiting Screwdriver: Greatbatch Medical, Torque Limiting Driver, Non Sterile, Rx Only. PRECIMED, Non Sterile. Zimmer, Non Sterile,…

Greatbatch Medical

FDA Devices Moderate Jun 8, 2016

STAT-Check Resuscitation Bag Manual Emergency Resuscitation Bag with Carbon dioxide gas analyzer Intended for use in various clinical situations to…

Ventlab LLC

FDA Devices Moderate Jun 8, 2016

Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments

Integra LifeSciences Corp.

FDA Devices Moderate Jun 8, 2016

Endoscope ED-450XL5 Operation Manual: Cleaning, Disinfection and Storage

Fujifilm Medical Systems U.S.A., Inc.

FDA Devices Moderate Jun 8, 2016

Dimension Vista 1500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V.3.6.2, Device listing # D011374, All serial numbers and lo…

Siemens Healthcare Diagnostics Inc.

FDA Devices Moderate Jun 8, 2016

Ingenuity Core 128 Computed Tomography X-ray Systems Product Usage: Intended to produce cross-sectional images of the body by computer reconstruc…

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Jun 8, 2016

Miltex Premium Grade Self-Lock Chisel Blade Handle, Catalogue No. 4-405, manual surgical instrument.

Integra York PA, Inc

FDA Devices Moderate Jun 8, 2016

SEAL,IS4000 PORTS,12MM&STAPLER,BOX of 10; Model numbers: 470380-04, 470380-05, 470380-06; Part number:470380. The da Vinci Xi Surgical System cannul…

Intuitive Surgical, Inc.

FDA Devices Moderate Jun 8, 2016

General Surgery Pack, part number 006880-3. This is a custom convenience surgical instrument disposable kit. There are multiple component in th…

Windstone Medical Packaging, Inc.

FDA Devices Moderate Jun 8, 2016

Endoscope ED-250XT5 Operations Manual: Cleaning Disinfection and Storage

Fujifilm Medical Systems U.S.A., Inc.

FDA Devices Moderate Jun 8, 2016

EVIS EXERA Duodenovideoscope Olympus TJF Type 160F/VF used with an Olympus video system center, light source, documentation equipment monitors, Endo…

Olympus Corporation of the Americas

FDA Devices Moderate Jun 8, 2016

AllergiEnd ST-9 Multiple Skin Test Applicator (Item 1000) and AllergiEnd ST-9 Multiple Well Test Tray (Item (1001). Contents: 8 applicators to perfor…

Medscience Inc

FDA Devices Moderate Jun 8, 2016

Curity X-Ray Detectable Laparotomy Sponges, Tray Pack, 18" x 18" (45.7 cm x 45.7 cm) Item Number: 6022

Covidien LLC

FDA Devices Moderate Jun 8, 2016

Novation Press-Fit Tapered, Standard Offset, HA Coated, 12/14 Taper, Femoral Stem; Catalog Number 160-10-16; For use in primary total hip arthropla…

Exactech, Inc.

FDA Devices Moderate Jun 8, 2016

SEAL,IS4000 PORTS,5MM-8MM,BOX of 10; Model numbers: 470361-03, 470361-04, 470361-05, 470361-06; Part number: 470361. The da Vinci Xi Surgical System…

Intuitive Surgical, Inc.

FDA Devices Moderate Jun 8, 2016

Video Duodenoscope

Pentax Medical Company

FDA Devices Moderate Jun 8, 2016

Pneumatic Impactor, General Surgery, With Microaire Hose Connector Professional Use, Medical Industry

MicroAire Surgical Instruments, LLC

FDA Devices Moderate Jun 8, 2016

Kerlix" X-Ray Detectable Laparotomy Sponges, Tray Pack, 8" x 32" (20.3 cm x 81.3 cm) Item Number: 4037

Covidien LLC

FDA Devices Moderate Jun 8, 2016

Novocastr Liquid Mouse Monoclonal Antibody CDX2 (CDX2) is recommended for the assessment of CDX2 protein in normal and neoplastic tissues.

Leica Microsystems, Inc.

FDA Devices Moderate Jun 8, 2016

Endoscope; ED-530XT Operation Manual 'Operation and Preparation' and 'Cleaning, Disinfection and Storage'

Fujifilm Medical Systems U.S.A., Inc.

FDA Devices Moderate Jun 8, 2016

Hip Preservation System Signature Series PreBent Burs under the following labels: 1) PreBent Spherical Bur, 5.5mm x 19cm Catalog Number HPS-HB11, 2) …

ConMed Corporation

FDA Devices Moderate Jun 8, 2016

Ingenuity Core Computed Tomography X-ray Systems, Product Usage: Intended to produce cross-sectional images of the body by computer reconstruc…

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Jun 8, 2016

Novation Press-Fit Tapered, Standard Offset, 12/14 Taper, Size 13, Femoral Stem, Catalog Number 160-00-13; For use in primary total hip arthroplasty.

Exactech, Inc.

CPSC Moderate Jun 8, 2016

Kwik Tek Recalls Sleds Due to Crash Hazard

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