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 The BioZorb LP Marker is an implantable radiopaque marker used to facilitate visualization of a soft tissue… Hologic BioZorb LP Marker, (Product number F0221), lot number 22A0RL, contained removable labels with an expiration date that indicated the product had already… Class IIFDA’s classOct 12, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 28 states named PublishedOct 12, 2022ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Massachusetts, Maryland, Michigan, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia and Washington named
- Medical device recall VIDAS CMV IgM, 30 tests Invalid calibrations (out of range high) while using the product. Class IIFDA’s classOct 5, 2022in FDA’s Enforcement Report18 statesnamed in where it went PublishedOct 5, 2022ClassClass IIStatusTerminatedWhereCalifornia, Florida, Georgia, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Maine, Missouri, New Jersey, New York, Ohio, Pennsylvania, Texas, Virginia, Wisconsin and West Virginia
- Medical device recall NanoSight LM10 fitted with LM12 module Product found to not comply to Class 1 Laser safety requirement. Class IIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall NanoSight LM10 fitted with LM14 module Product found to not comply to Class 1 Laser safety requirement. Class IIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TANDEM LIFE LivaNova LIFESPARC Controller Critical Failure of the LifeSPARC controller when the software freezes or crashes and the screen does not display data. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2022ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Collagen Dental Wound Dressing - Bovine Dermis Tap, 25mm x 75mm Product was The packaging may not be sealed, which could compromise sterility. Class IIFDA’s classOct 5, 2022in FDA’s Enforcement Report6 statesnamed in where it went PublishedOct 5, 2022ClassClass IIStatusOngoingWhereIllinois, Indiana, Michigan, North Carolina, Ohio and Texas
- Medical device recall Short tibial bearing MK4 - Std, STM A MK4 Tibial Bearing was supplied with the intention to mate with the Tibial Metal Casing in-situ. Class IIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedOct 5, 2022ClassClass IIStatusOngoingWhereNew York
- Medical device recall Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH The kits are being recalled due to a lack of sterility of a spare needle contained within the kits. Class IIFDA’s classOct 5, 2022in FDA’s Enforcement Report10 statesnamed in where it went PublishedOct 5, 2022ClassClass IIStatusTerminatedWhereAlabama, Florida, Georgia, Illinois, Louisiana, Missouri, New Jersey, New York, Tennessee and Texas
- Medical device recall BD Pyxis MedBank Cabinet Software v2.1.2.9 Legacy MedBank Cabinets with Matrix Drawers include The automated dispensing cabinet software update included a .dll file that is not compatible with MedBank Cabinet stations with MedCart Matrix drawers. Class IIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedOct 5, 2022ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19 Software calibration error with product equip with a Dose Area Product (DAP) meter. Class IIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedOct 5, 2022ClassClass IIStatusOngoingWhereNationwide, and California, Nevada, New York, Ohio, Texas and Washington named
- Medical device recall DERMARITE INDUSTRIES SafeWash Saline Saline Wound Flush SafeWash 7.1 oz Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2022ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall a. Skin Adhesive McKesson LiquiBand Exceed 0.4 mL Liquid Dome Applicator Tip 2-Octyl Cyanoacrylate. Model… Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2022ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall DERMARITE INDUSTRIES DermaCol 100 Collagen Powder DermaCol 100 Collagen 1 Gram Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2022ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall a. SporView Culture Set SporView Sterilization Biological Indicator Kit Steam / EO Gas / Dry Heat / Chemical… Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2022ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall SPS MEDICAL SUPPLY Crosstex International Sterilization Roll Sani-Roll Ethylene Oxide (EO) Gas / Steam 3 Inch… Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2022ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall a. SPS MEDICAL SUPPLY Steam Indicator Strip SPSmedical Sterilization Chemical Indicator Strip Steam 4 Inch… Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2022ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall a. STERIS CORP Celerity Celerity 20 Sterilization Indicator Challenge Pack Steam 3 Inch Length Model Number:… Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2022ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall a. Comply INDICATOR, COMPLY VAPOR GAS (250/BG 4BG/CS) 3M Model Number: 1248. b. 3M Attest INDICATOR, CHEMICAL… Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2022ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall Cooper Surgical PREFILTER, SMOKE EVAC Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2022ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall a. DERMARITE INDUSTRIES DermaCol Collagen Dressing DermaCol Without Border Collagen / Sodium Alginate /… Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2022ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall MERIT MEDICAL SYSTEMS StayFIX FIXATION DEVICE, STAYFIX F/PERCUTAN CATH 5FR-14FR Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2022ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall a. TIDI PRODUCTS, LLC AquaGuard DRESSING, AQUA GUARD MOISTR 7X7 (5/PK) 9CENCO Catalog #68751510104. b. TIDI… Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2022ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall a. DERMA SCIENCES, INC Surgitube BANDAGE, GAUZE SURGI WHT SZ15/8” 50YDS Catalog #GL-219. b. DERMA SCIENCES,… Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2022ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall a. INTEGRA LIFESCIENCE (WND CARE) Shur-Conform Oil Emulsion Oil Emulsion Impregnated Dressing Shur-Conform 3… Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2022ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall Skin markers: a Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2022ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall Medical Monofilament Manufacturing MONOFILIMENT TEST, SENSORY F/FOOT 10GM Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2022ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall Absorbent dressings Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2022ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall a. Dynarex DRESSING, UNNA BOOT 3”X10’ (12/CS), Catalog # 3453. b. Dynarex DRESSING, UNNA BOOT BANDAGE 4”X10’… Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2022ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall a. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, CALCIUM ALGINATE SHEET 4”X8” (5/BX 10BX/CS), Catalog #3563.… Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2022ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall a. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, WOUND GELLING FIBERHIGH-ABSRB 4”X4 3/4” (10/BX) Catalog… Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2022ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall 3M SYSTAGENIX/KCI KerraCel Ag DRESSING, WOUND KERRACEL AG 4X5 Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2022ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall a. DYNAREX WeCare PETROLATUM JELLY, WHT 5GM (144/BX 6BX/CS) DYNREX Catalog #1140. b. DYNAREX Dynarex… Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2022ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall a. DYNAREX Nice’n Fresh WIPE, BABY WET 6X6.75” (140/CN12CN/CS) Catalog # 1313. b. DYNAREX DynaCare WIPE, WET… Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. Class IIIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2022ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 1002821, 1002822, 1002823, and… The IFU incorrectly states the insulin fill value of two sizes of cannula which can result in an initial insulin infusion to be fewer units than intended. Class IIFDA’s classOct 5, 2022in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedOct 5, 2022ClassClass IIStatusTerminatedWhereCalifornia
- Medical device recall t:slim X2 insulin pump Insulin pumps may have the following issues: 1) Malfunction 6 Non-Volatile Memory, 2) Inaccurate (Fluctuating) Battery Life Display, 3) Touchscreen Staying On,… Class IIFDA’s classOct 5, 2022in FDA’s Enforcement Report53 statesnamed in where it went PublishedOct 5, 2022ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall t:slim X2 insulin pump Insulin pumps may have the following issues: 1) Malfunction 6 Non-Volatile Memory, 2) Inaccurate (Fluctuating) Battery Life Display, 3) Touchscreen Staying On,… Class IIFDA’s classOct 5, 2022in FDA’s Enforcement Report53 statesnamed in where it went PublishedOct 5, 2022ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Olympus POWERSEAL 5MM, 23CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION An out of specification component preventing the blue retention ring from keeping the rotation knob in place. Class IIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Olympus POWERSEAL 5MM, 37CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION An out of specification component preventing the blue retention ring from keeping the rotation knob in place. Class IIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Olympus POWERSEAL 5MM, 44CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION An out of specification component preventing the blue retention ring from keeping the rotation knob in place. Class IIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Dimension Magnesium (MG) Flex reagent cartridge Siemens Material Number (SMN)/REF (Catalog… Dimension Magnesium (MG) Flex reagent cartridge lots may exhibit imprecision for Quality Control (QC) and produce Abnormal Reaction flags. Class IIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 5, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Starling Monitor Labeling has incorrect or incomplete Unique Device Identification (UDI) information; and the barcodes are not compliant with GS-1 standards. Class IIIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2022ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall Ambra PACS, Ambra ProViewer A race condition between the storage system and services database has the potential to revert edits made to patient information upon first ingestion of a study. Class IIFDA’s classOct 5, 2022in FDA’s Enforcement Report43 statesnamed in where it went PublishedOct 5, 2022ClassClass IIStatusOngoingWhereArkansas, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall VenaCure EVLT KIT WITH SPOTLIGHT OPS SHEATH 55CM Ref./ OPS Fiber packaged within specific VenaCure EVLT Procedure Kits does not meet the required dimensional specification, may result in damage to the sheath,… Class IIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedOct 5, 2022ClassClass IIStatusOngoingWhereNationwide, and Florida, North Carolina, New Jersey, New Mexico, New York, Pennsylvania, Texas and Virginia named
- Medical device recall IMMULITE 2000 and IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI) Siemens Material Number (SMN):… An average negative bias of -23% with IMMULITE 2000/IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI) when compared to other in-date kit lots, there… Class IIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedOct 5, 2022ClassClass IIStatusOngoingWhereNationwide, and Florida, Indiana, Massachusetts, Michigan, New Hampshire, New Jersey, New York, Ohio, Texas and Utah named
- Medical device recall OSSUR Power Knee Battery may dislodge from the Power Knee Class IIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 36 states named PublishedOct 5, 2022ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall Humidifier bottle and syringe filter kit There is a potential breach to the sterile barrier containing the Humidifier Bottles due to the packaging of the filter box located inside the bottle packaging. Class IIFDA’s classOct 5, 2022in FDA’s Enforcement Report25 statesnamed in where it went PublishedOct 5, 2022ClassClass IIStatusOngoingWhereAlabama, Arizona, California, Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Kansas, Massachusetts, Michigan, Minnesota, Missouri, New Jersey, New York, Ohio, Oregon, South Carolina, Texas, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall Humidifier bottle and syringe filter kit There is a potential breach to the sterile barrier containing the Humidifier Bottles due to the packaging of the filter box located inside the bottle packaging. Class IIFDA’s classOct 5, 2022in FDA’s Enforcement Report25 statesnamed in where it went PublishedOct 5, 2022ClassClass IIStatusOngoingWhereAlabama, Arizona, California, Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Kansas, Massachusetts, Michigan, Minnesota, Missouri, New Jersey, New York, Ohio, Oregon, South Carolina, Texas, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall Amplatz extra Stiff Wire Guide, Stiff Guidewire (OUS ONLY) Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Class IIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2022ClassClass IIStatusOngoingWhereNationwide
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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