Medical devices, 2022
Shortlist up to four to read them side by side.
2,192 medical device recalls FDA’s Enforcement Report published in 2022, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 6, 2026.
2,192of 2,192 medical device recallsshown with your filters
The list
- Medical device recall CENTURION MEDICAL PRODUCTS, LP Centurion CATH KIT, FML W/LUBE 8FR Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall COOPER SURGICAL Milex PESSARY, RING MILEX INCONT FLEXIBLE SZ6 1 3/4” Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MORRISON MEDICAL Morrison Medical OB KIT, HARD PK SEALED W/CARDBOARD BX MORMED Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DYNAREX Dynarex SWABSTICK, PVP Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Dynarex SWAB, LEMON GLYCERIN Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DYNAREX DynaLube LUBRICATING JELLY, STR 2.7GM Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall FISHER SCIENTIFIC Fisherbrand SWAB, ROUND BOTTOM CLR Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDICAL CHEMICAL CORPORATION Total-Fix STOOL COLL KIT, TOTAL FIX PARASITOLOGY Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE Battery performance issues. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 24, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2022ClassClass IStatusOngoingWhereNationwide
- Medical device recall (1) CVS Health Sterile Surgical Pads, Cushion Comfort The product falls apart during handling after removal from its primary packaging. Class IIFDA’s classAug 24, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedAug 24, 2022ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Florida, Indiana, Michigan, Missouri, New Jersey, New York, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas and Virginia named
- Medical device recall The Alinity m System Incorrect optical calibration Class IIFDA’s classAug 24, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 24, 2022ClassClass IIStatusCompletedWhereNo state named
- Medical device recall Power electronic box, Part #AS-0066, subassembly for the MyoCycle MC-2. Screws mounting an internal power supply may come loose during shipping resulting in increased risk of high voltage electrical shock. Class IIFDA’s classAug 24, 2022in FDA’s Enforcement Report23 statesnamed in where it went PublishedAug 24, 2022ClassClass IIStatusTerminatedWhereArizona, California, Connecticut, Florida, Georgia, Idaho, Illinois, Kentucky, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New Mexico, New York, Ohio, Oregon, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall ARIES SARS-CoV-2 Assay SARS-CoV-2 assay that detects SARS-CoV-2 ORF1ab and N genes may not detect the ORF1ab gene. Class IIFDA’s classAug 24, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedAug 24, 2022ClassClass IIStatusOngoingWhereNationwide, and California, Kentucky, Maine, Mississippi, Nebraska, Tennessee and Texas named
- Medical device recall CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022. Class IIFDA’s classAug 24, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VERIQUICK PREGNANCY TEST 1CT Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022. Class IIFDA’s classAug 24, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Veriquick Pregnancy Test 2CT Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022. Class IIFDA’s classAug 24, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DENTEMP ONE STEP .077OZ Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022. Class IIFDA’s classAug 24, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SKYN ORIGINAL NON LATEX CONDOM 12CT Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022. Class IIFDA’s classAug 24, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall B L BIOTRU MULTI PURPOSE SOLUTION 4 FLOZ Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022. Class IIFDA’s classAug 24, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CURAD FIRST AID KIT Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022. Class IIFDA’s classAug 24, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CLEAR EYES CONTCT LENS DRPS LBRCTNG .5FO Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022. Class IIFDA’s classAug 24, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall GS DENTURE CLEANSER GRN TAB 40CT Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022. Class IIFDA’s classAug 24, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TRVL KIT TOTHBRSH CAP PASTE IN POUCH 1CT Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022. Class IIFDA’s classAug 24, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CURAD STRNG WATRPRF STRIP 1IN 20CT Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022. Class IIFDA’s classAug 24, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall FIRST RESPONSE 2 CT Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022. Class IIFDA’s classAug 24, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall FIXODENT ORG CREAM 2.4OZ Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022. Class IIFDA’s classAug 24, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall POLIGRIP ADH CREAM FREE 2.4OZ Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022. Class IIFDA’s classAug 24, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall OPTI FREE REPLENISH MULTI PURPOSE 2 OZ Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022. Class IIFDA’s classAug 24, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall NEW SKIN LIQUID BANDAGE CLEAR .3FL OZ Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022. Class IIFDA’s classAug 24, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall AT HOME MARIJUANA TEST STRIP Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022. Class IIFDA’s classAug 24, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall GS SALINE SOLUTION 12FL OZ Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022. Class IIFDA’s classAug 24, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall POLIDENT DENTURE CLEANSERS 84 CT Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022. Class IIFDA’s classAug 24, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SIMPLY SALINE NASAL MIST 3.1 OZ Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022. Class IIFDA’s classAug 24, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall LIFESTYLES ULTRA SENSITIVE CONDOMS 12CT Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022. Class IIFDA’s classAug 24, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall KY JELLY LUBRICANT 2 FL OZ Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022. Class IIFDA’s classAug 24, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Sklar Instruments IV Cath Dressing Tray Cs/25 Re-Order Number: 96-1708 Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains natural rubber latex. Class IIFDA’s classAug 24, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 24, 2022ClassClass IIStatusTerminatedWhereNationwide, and Florida and Pennsylvania named
- Medical device recall Wolf-Pak Premium Dressing Kit with GuardVA Cs/30 Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains natural rubber latex. Class IIFDA’s classAug 24, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 24, 2022ClassClass IIStatusTerminatedWhereNationwide, and Florida and Pennsylvania named
- Medical device recall Wolf Pak Premium Dressing Change Kit with Statlock CS/30 Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains natural rubber latex. Class IIFDA’s classAug 24, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 24, 2022ClassClass IIStatusTerminatedWhereNationwide, and Florida and Pennsylvania named
- Medical device recall Wolf Pak Premium Dressing Change Kit with GuardVA and Statlok Cs/30 Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains natural rubber latex. Class IIFDA’s classAug 24, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 24, 2022ClassClass IIStatusTerminatedWhereNationwide, and Florida and Pennsylvania named
- Medical device recall NARMD MEDICAL DEPOT Scissors Iris Curved 4.5” The sterile barrier may be compromised. Class IIFDA’s classAug 24, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 24, 2022ClassClass IIStatusOngoingWhereNationwide, and South Carolina named
- Medical device recall NARMD MEDICAL DEPOT Forceps - Kelly Straight 5.5” The sterile barrier may be compromised. Class IIFDA’s classAug 24, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 24, 2022ClassClass IIStatusOngoingWhereNationwide, and South Carolina named
- Medical device recall NARMD MEDICAL DEPOT Forceps - Kelly Curved 5.5” The sterile barrier may be compromised. Class IIFDA’s classAug 24, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 24, 2022ClassClass IIStatusOngoingWhereNationwide, and South Carolina named
- Medical device recall BD PhaSealTM Y-Site Connector (C80)- airtight and leak-proof Closed System Drug Transfer Device (CSTD) that… Incorrect expiration date listed on the product labels. Class IIFDA’s classAug 24, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedAug 24, 2022ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Illinois, Maryland, Michigan, Oregon, Pennsylvania, Puerto Rico, Tennessee and Texas named
- Medical device recall Echelon -14, 45 Tip Shape Outer carton packaging of microcatheters were exposed to wet substance during transport. Class IIFDA’s classAug 24, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Echelon -14 Micro Catheter Outer carton packaging of microcatheters were exposed to wet substance during transport. Class IIFDA’s classAug 24, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall AXIOM Sensis or Sensis Vibe Combo systems as follows: System Material # AXIOM Sensis, Combo 64 6623974 The Sensis Signal Input Box provides hooks as a milled item on the bottom of the box support the possibility of mounting the Signal Input Box on an accessory… Class IIIFDA’s classAug 24, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2022ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall HXBL/WETEX/Genesis Biomedical Viral Transport Container Distributed VTM outside of VTM Guidance and without clearance. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 17, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedAug 17, 2022ClassClass IStatusOngoingWhereNationwide, and California, Florida, Illinois and New York named
- Medical device recall HXBL/WETEX/Genesis Biomedical Viral Transport Container Distributed VTM outside of VTM Guidance and without clearance. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 17, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedAug 17, 2022ClassClass IStatusOngoingWhereNationwide, and California, Florida, Illinois and New York named
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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