PlainRecalls

2022 Recalls

4,921 recalls · Page 3 of 99

2022 Recall Year Insight

Federal agencies issued 4,921 product recalls indexed by PlainRecalls in calendar year 2022. That represents about 5.86% of the 83,949 total recalls we track from 1995 through the present, and averages roughly 13.5 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 99 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 2022.

On this page of 50 records, severity classification shows 7 critical, 43 moderate, and 0 lower-severity recalls. The page references 6 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 2022 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 Devices Critical Dec 21, 2022

Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700 (IPN001112), cardiac pump

ARROW INTERNATIONAL Inc.

FDA Devices Moderate Dec 21, 2022

GEO-MED PLASTIC HAND PACK RF, REF 89-6667.10

DeRoyal Industries Inc

FDA Devices Moderate Dec 21, 2022

DeRoyal TRACECART POSTEROR LAMI MICRODISC TRACECART, REF 53-1960.02

DeRoyal Industries Inc

FDA Devices Moderate Dec 21, 2022

DeRoyal HAND PACK, REF 89-10314.02

DeRoyal Industries Inc

FDA Devices Moderate Dec 21, 2022

HENRY SCHEIN, Novasure Pack, Item No.570-1462, general surgery tray

Stradis Medical, LLC dba Stradis Healthcare

FDA Devices Moderate Dec 21, 2022

HENRY SCHEIN, UNIVERSAL TRAY, Item No.570-2787

Stradis Medical, LLC dba Stradis Healthcare

FDA Devices Moderate Dec 21, 2022

GEO-MED TOTAL KNEE PACK A & B PGYK, REF 89-5796.13

DeRoyal Industries Inc

FDA Devices Moderate Dec 21, 2022

DeRoyal MYELOGRAM PACK, REF 89-9304.06

DeRoyal Industries Inc

FDA Devices Moderate Dec 21, 2022

STRADIS HEALTHCARE, CURVED TIP SYRINGE, Item No.60060GCTS,

Stradis Medical, LLC dba Stradis Healthcare

FDA Devices Moderate Dec 21, 2022

HENRY SCHEIN, PROCEDURE KIT, Item No.570-1508, general surgery tray

Stradis Medical, LLC dba Stradis Healthcare

FDA Devices Moderate Dec 21, 2022

DeRoyal PEDI ORTHO PACK, REF 89-5323.20

DeRoyal Industries Inc

FDA Devices Critical Dec 21, 2022

Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN916549), cardiac pump

ARROW INTERNATIONAL Inc.

FDA Devices Moderate Dec 21, 2022

HENRY SCHEIN, Vas Pack, Item No.888-2520,

Stradis Medical, LLC dba Stradis Healthcare

FDA Devices Moderate Dec 21, 2022

STRADIS HEALTHCARE, Phleb, Item No.682-1425,

Stradis Medical, LLC dba Stradis Healthcare

FDA Devices Moderate Dec 21, 2022

HENRY SCHEIN, Labiaplasty PackItem No.570-3118,

Stradis Medical, LLC dba Stradis Healthcare

FDA Devices Moderate Dec 21, 2022

HENRY SCHEIN, PACEMAKER PACK IItem No.570-2793

Stradis Medical, LLC dba Stradis Healthcare

FDA Devices Moderate Dec 21, 2022

Surgical room, Implant Pack, Item No.41111UTI, oral surgery tray

Stradis Medical, LLC dba Stradis Healthcare

FDA Devices Moderate Dec 21, 2022

DeRoyal BASIC NEURO PACK, REF 89-7258.10

DeRoyal Industries Inc

FDA Devices Moderate Dec 21, 2022

STRADIS HEALTHCARE, Basic Implant Pack, Item No.40561BIP, oral surgery tray

Stradis Medical, LLC dba Stradis Healthcare

FDA Devices Moderate Dec 21, 2022

NexGen Option Stemmed Tibial Component Size 7, Item Number 00-5986-057-01

Zimmer, Inc.

FDA Devices Moderate Dec 21, 2022

DeRoyal TOTAL KNEE PACK, REF 89-9300.08

DeRoyal Industries Inc

FDA Devices Moderate Dec 21, 2022

STRADIS HEALTHCARE, Surg Pack, Item No.40450SMS, dental

Stradis Medical, LLC dba Stradis Healthcare

FDA Devices Critical Dec 21, 2022

Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2, REF IAP-0435 (IPN000312), cardiac pump

ARROW INTERNATIONAL Inc.

FDA Devices Moderate Dec 21, 2022

HENRY SCHEIN, MAJOR EXTREMITY PACK, Item No.570-2783,

Stradis Medical, LLC dba Stradis Healthcare

FDA Devices Critical Dec 21, 2022

Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/EMEA, REF IAP-0600 (IPN001108), cardiac pump

ARROW INTERNATIONAL Inc.

FDA Devices Moderate Dec 21, 2022

DeRoyal TRACECART SHOULDER ARTHROSCOPY TRACECART, REF 53-1962.02

DeRoyal Industries Inc

FDA Devices Moderate Dec 21, 2022

DeRoyal MAJOR ORAL PACK RF, REF 89-3936.15

DeRoyal Industries Inc

FDA Devices Critical Dec 21, 2022

Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500SV (IPN000327), cardiac pump

ARROW INTERNATIONAL Inc.

FDA Devices Moderate Dec 21, 2022

www.StradisHealthcare.com, Endovenous Pack, Item No.682-494,

Stradis Medical, LLC dba Stradis Healthcare

FDA Devices Moderate Dec 21, 2022

GEO-MED LOCAL ANESTHESIA PACK, REF 89-10800.01

DeRoyal Industries Inc

FDA Devices Moderate Dec 21, 2022

CarePoint 60 mL Syringe Without Needle, REF: 04-7560

Allison Medical, Inc.

FDA Devices Moderate Dec 21, 2022

DeRoyal EYE TRAY, REF 89-4957.08

DeRoyal Industries Inc

FDA Devices Moderate Dec 21, 2022

DeRoyal SPINAL FUSION PACK, REF 89-7515.12

DeRoyal Industries Inc

FDA Devices Moderate Dec 21, 2022

DeRoyal CUSTOM NEURO PACK, REF 89-7353.17

DeRoyal Industries Inc

FDA Devices Moderate Dec 21, 2022

DeRoyal EMERGENT TRAUMA PACK, REF 89-9453.14

DeRoyal Industries Inc

FDA Devices Moderate Dec 21, 2022

HENRY SCHEIN, EXTREMITY PACK, Item No.570-2946

Stradis Medical, LLC dba Stradis Healthcare

FDA Devices Moderate Dec 21, 2022

DeRoyal LAMINECTOMY SPINAL FUSION PACK, REF 89-9105.08

DeRoyal Industries Inc

FDA Devices Moderate Dec 21, 2022

NexGen Option Stemmed Tibial Component Size 5, Item Number 00-5986-047-01

Zimmer, Inc.

FDA Devices Moderate Dec 21, 2022

DeRoyal CATARACT PACK, REF 89-9241.04

DeRoyal Industries Inc

FDA Devices Critical Dec 21, 2022

Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500NL (IPN000326), cardiac pump

ARROW INTERNATIONAL Inc.

FDA Devices Moderate Dec 21, 2022

DeRoyal CRANI PACK, REF 89-10202.03

DeRoyal Industries Inc

FDA Devices Moderate Dec 21, 2022

NexGen Option Stemmed Tibial Component Size 4, Item Number 00-5986-037-02

Zimmer, Inc.

FDA Devices Moderate Dec 21, 2022

STRADIS HEALTHCARE, Endo Pack, Item No.682-509,

Stradis Medical, LLC dba Stradis Healthcare

FDA Devices Moderate Dec 21, 2022

DeRoyal LAPINECTOMY PACK, REF 89-7198.11

DeRoyal Industries Inc

FDA Devices Moderate Dec 21, 2022

STRADIS HEALTHCARE, Surg, Item No.40551TMS. oral surgery tray

Stradis Medical, LLC dba Stradis Healthcare

FDA Devices Moderate Dec 21, 2022

DeRoyal TOTAL HIP PACK, REF 89-9113.06

DeRoyal Industries Inc

FDA Devices Critical Dec 21, 2022

Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT 2 IAPB, REF IAP-0400 (IPN000302), cardiac pump

ARROW INTERNATIONAL Inc.

FDA Devices Moderate Dec 21, 2022

Power-PRO 2, Model No. 6507, Item No. 650705550001 (US); 650700000000 (International)

Stryker Medical Division of Stryker Corporation

FDA Devices Moderate Dec 21, 2022

DeRoyal TOTAL HIP PACK, REF 89-9113.07

DeRoyal Industries Inc

FDA Devices Moderate Dec 21, 2022

DeRoyal PACEMAKER ICD PACK, REF 89-10902.01

DeRoyal Industries Inc

Nearby Recall Years

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

Compare 2022 with 2021 →

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 2022