PlainRecalls

2016 Recalls

8,148 recalls · Page 127 of 163

2016 Recall Year Insight

Federal agencies issued 8,148 product recalls indexed by PlainRecalls in calendar year 2016. That represents about 9.71% of the 83,949 total recalls we track from 1995 through the present, and averages roughly 22.3 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 163 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 1 critical, 49 moderate, and 0 lower-severity recalls. The page references 12 distinct recalling firms operating in 1 distinct product categories, with 50 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (50), 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 Devices Moderate Apr 20, 2016

Catalog Number: 9002511 MINOR SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound heali…

Customed, Inc

FDA Devices Moderate Apr 20, 2016

Catalog Number: 900944 CATARACT SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound hea…

Customed, Inc

FDA Devices Moderate Apr 20, 2016

BARDEX I.C. Anti-Infective 2-Way 3cc Foley Catheter, Rx only. Intended for urinary bladder drainage in female patients requiring catheterization for…

C.R. Bard, Inc.

FDA Devices Moderate Apr 20, 2016

Catalog Number: 900618A LAPAROSCOPY-GYN SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wo…

Customed, Inc

FDA Devices Moderate Apr 20, 2016

Catalog Number: 9001402 PLASTIC SURGERY PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound heali…

Customed, Inc

FDA Devices Moderate Apr 20, 2016

X-Guide Surgical Navigation System, X-Clip Bulk Kit The X-Guide Surgical Navigation System is a computerized navigational system intended to provi…

X-NAV Technologies, LLC

FDA Devices Moderate Apr 20, 2016

Catalog Number: 9002164 FEMORAL SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound heal…

Customed, Inc

FDA Devices Moderate Apr 20, 2016

Catalog Number: 900633 FAN FOLD SHEET 44 X 58 Used by medical staff to perform surgical procedures and patient care procedures such as wound heal…

Customed, Inc

FDA Devices Moderate Apr 20, 2016

Catalog Number: 900168 LABOR & DELIVERY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as w…

Customed, Inc

FDA Devices Moderate Apr 20, 2016

SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Du…

Synthes (USA) Products LLC

FDA Devices Moderate Apr 20, 2016

Catalog Number: 900164 FEMORAL SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound hea…

Customed, Inc

FDA Devices Moderate Apr 20, 2016

Custom Tubing Packs Custom tubing pack for oxygenators

Maquet Cardiovascular Us Sales, Llc

FDA Devices Moderate Apr 20, 2016

Catalog Number: 900796 FEMORAL ANGIOGRAPHY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such a…

Customed, Inc

FDA Devices Moderate Apr 20, 2016

GE Healthcare, Aisys Carestation.

GE Medical Systems, LLC

FDA Devices Moderate Apr 20, 2016

The Concerto Basic Shower Trolley is intended for assisted hygiene care, especially showering and bathing of residents in care environments such as s…

Arjo, Inc. dba ArjoHuntleigh

FDA Devices Moderate Apr 20, 2016

Catalog Number: 900064 WOUND CLOSURE TRAY II Used by medical staff to perform surgical procedures and patient care procedures such as wound healin…

Customed, Inc

FDA Devices Moderate Apr 20, 2016

Diana Automated Compounding System, Diana Onco Plus 1.2, Item No. ASN222, ASN222-GST, ASN222-R The Diana is an automated compounding device for the …

ICU Medical, Inc.

FDA Devices Moderate Apr 20, 2016

Catalog Number: 900419 LABOR & DELIVERY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as w…

Customed, Inc

FDA Devices Moderate Apr 20, 2016

Catalog Number: 9001154 WOUND MANAGEMENT TRAY Used by medical staff to perform surgical procedures and patient care procedures such as wound heali…

Customed, Inc

FDA Devices Moderate Apr 20, 2016

Catalog Number: 900547 BASIC SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healin…

Customed, Inc

FDA Devices Moderate Apr 20, 2016

Catalog Number: 900741A ORTHO-IMPLANT SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as woun…

Customed, Inc

FDA Devices Moderate Apr 20, 2016

Catalog Number: 900742A CARPAL TUNEL LARGE SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as…

Customed, Inc

FDA Devices Critical Apr 20, 2016

Dexcom G4 PLATINUM Receiver with Share Receiver Part Number: MT22495 Receiver (mg/dL), Black; MT22495-PNK, Receiver (mg/dL), Pink; MT22495-BLU, Rec…

Dexcom Inc

FDA Devices Moderate Apr 20, 2016

BARDEX I.C. Anti-Infective 2-Way Red Latex Foley Catheter, 5cc (Council Model); Intended for urinary bladder drainage in female patients requiring c…

C.R. Bard, Inc.

FDA Devices Moderate Apr 20, 2016

Catalog Number: 900278 URETHRAL CATHETER TRAY 14FR Used by medical staff to perform surgical procedures and patient care procedures such as woun…

Customed, Inc

FDA Devices Moderate Apr 20, 2016

Catalog Number: 9001574 LEGGINS 30X42 W/7" CUFF Used by medical staff to perform surgical procedures and patient care procedures such as wound he…

Customed, Inc

FDA Devices Moderate Apr 20, 2016

Catalog Number: 9002614 HIP AND KNEE REPLACEMENT SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures s…

Customed, Inc

FDA Devices Moderate Apr 20, 2016

Diana Automated Compounding System, Diana Onco 3xx, Item No. ASN303 The Diana is an automated compounding device for the accurate, safe and efficien…

ICU Medical, Inc.

FDA Devices Moderate Apr 20, 2016

Catalog Number: 900450 LAPAROTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound h…

Customed, Inc

FDA Devices Moderate Apr 20, 2016

Diana Automated Compounding System, Diana V1.3, Item No. CH5300, CH5300R The Diana is an automated compounding device for the accurate, safe and eff…

ICU Medical, Inc.

FDA Devices Moderate Apr 20, 2016

Catalog Number: 900548A PERY-GYN SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound hea…

Customed, Inc

FDA Devices Moderate Apr 20, 2016

Catalog Number: 9001198 WOUND MANAGE II Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, s…

Customed, Inc

FDA Devices Moderate Apr 20, 2016

da Vinci S Surgical System (IS1200/IS2000/IS3000) user manual, instrument & accessory. Product Usage: The Intuitive Surgical Endoscopic Instrumen…

Intuitive Surgical, Inc.

FDA Devices Moderate Apr 20, 2016

Catalog Number: 900403 CESAREAN SECTION SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as w…

Customed, Inc

FDA Devices Moderate Apr 20, 2016

Oblique Posterior Atraumatic Lumbar (OPAL) System, Polymeric spinal fusion cage, non-sterile, OPAL Spacer 10 mm x 24 mm, 11 mm Height - Revolve Pr…

Synthes (USA) Products LLC

FDA Devices Moderate Apr 20, 2016

Catalog Number: 900629 STERILE OR CLOTH TOWEL BLUE Used by medical staff to perform surgical procedures and patient care procedures such as wound…

Customed, Inc

FDA Devices Moderate Apr 20, 2016

BARD ArcticGel Pads Product Usage: The Arctic Sun Temperature Management System is intended for monitoring and controlling patient temperature. A…

C.R. Bard, Inc.

FDA Devices Moderate Apr 20, 2016

SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Du…

Synthes (USA) Products LLC

FDA Devices Moderate Apr 20, 2016

SOMATOM Definition AS, a family of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission…

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Apr 20, 2016

Catalog Number: 9002510 UROLOGY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound hea…

Customed, Inc

FDA Devices Moderate Apr 20, 2016

Catalog Number: 9002469 BASIC SURGICAL PACK IV Used by medical staff to perform surgical procedures and patient care procedures such as wound he…

Customed, Inc

FDA Devices Moderate Apr 20, 2016

Catalog Number: 9002193 SHOULDER ARTHROSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such …

Customed, Inc

FDA Devices Moderate Apr 20, 2016

Catalog Number: 9001738 UROLOGY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound hea…

Customed, Inc

FDA Devices Moderate Apr 20, 2016

Catalog Number: 9001296 PREMIUM LAPAROTOMY PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound he…

Customed, Inc

FDA Devices Moderate Apr 20, 2016

Catalog Number: 900169 UNIVERSAL SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound he…

Customed, Inc

FDA Devices Moderate Apr 20, 2016

Catalog Number: 9001933 OPHTALMIC SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound h…

Customed, Inc

FDA Devices Moderate Apr 20, 2016

Bard TruGuide Disposable Coaxial Biopsy Needle Product Usage: The TruGuide Disposable Coaxial Biopsy Needles are intended for use as a guiding ne…

Bard Peripheral Vascular Inc

FDA Devices Moderate Apr 20, 2016

Catalog Number: 900010 SUTURE REMOVAL KIT Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, …

Customed, Inc

FDA Devices Moderate Apr 20, 2016

Catalog Number: 9002940 OBSTETRICAL SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound …

Customed, Inc

FDA Devices Moderate Apr 20, 2016

Catalog Number: 900277 SUCTION CATHETER TRAY 14FR WITH SODIUM CHLORIDE 0.9% IRRIGATION Used by medical staff to perform surgical procedures and p…

Customed, 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 — consumer product and vehicle recall feeds for 2016