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 5, 2026.
2,192of 2,192 medical device recallsshown with your filters
The list
- Medical device recall Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit There is the potential for inadequate connection between the top and bottom housings of the Micro Clave Clear Connectors included in the Arrow MAC Two-Lumen… FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 21, 2022in FDA’s Enforcement Report6 statesnamed in where it went PublishedDec 21, 2022ClassClass IStatusTerminatedWhereFlorida, Georgia, Kentucky, Ohio, Pennsylvania and West Virginia
- Medical device recall Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT 2 IAPB There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 21, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 21, 2022ClassClass IStatusOngoingWhereNo state named
- Medical device recall Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 IAPB, REFURBISHED There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 21, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 21, 2022ClassClass IStatusOngoingWhereNo state named
- Medical device recall Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2 There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 21, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 21, 2022ClassClass IStatusOngoingWhereNo state named
- Medical device recall Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 21, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 21, 2022ClassClass IStatusOngoingWhereNo state named
- Medical device recall Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE REFURBISHED There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 21, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 21, 2022ClassClass IStatusOngoingWhereNo state named
- Medical device recall Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT 2 WAVE There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 21, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 21, 2022ClassClass IStatusOngoingWhereNo state named
- Medical device recall Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2 WAVE REFURBISHED There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 21, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 21, 2022ClassClass IStatusOngoingWhereNo state named
- Medical device recall Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/EMEA There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 21, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 21, 2022ClassClass IStatusOngoingWhereNo state named
- Medical device recall Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/EMEA There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 21, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 21, 2022ClassClass IStatusOngoingWhereNo state named
- Medical device recall Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 21, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 21, 2022ClassClass IStatusOngoingWhereNo state named
- Medical device recall Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 21, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 21, 2022ClassClass IStatusOngoingWhereNo state named
- Medical device recall Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 21, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 21, 2022ClassClass IStatusOngoingWhereNo state named
- Medical device recall Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 21, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 21, 2022ClassClass IStatusOngoingWhereNo state named
- Medical device recall Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 21, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 21, 2022ClassClass IStatusOngoingWhereNo state named
- Medical device recall Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus REFURBISHED There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 21, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 21, 2022ClassClass IStatusOngoingWhereNo state named
- Medical device recall Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 21, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 21, 2022ClassClass IStatusOngoingWhereNo state named
- Medical device recall Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 21, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 21, 2022ClassClass IStatusOngoingWhereNo state named
- Medical device recall Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 21, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 21, 2022ClassClass IStatusOngoingWhereNo state named
- Medical device recall Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 21, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 21, 2022ClassClass IStatusOngoingWhereNo state named
- Medical device recall Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 21, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 21, 2022ClassClass IStatusOngoingWhereNo state named
- Medical device recall Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 21, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 21, 2022ClassClass IStatusOngoingWhereNo state named
- Medical device recall Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 21, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 21, 2022ClassClass IStatusOngoingWhereNo state named
- Medical device recall Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 21, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 21, 2022ClassClass IStatusOngoingWhereNo state named
- Medical device recall Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 21, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 21, 2022ClassClass IStatusOngoingWhereNo state named
- Medical device recall Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 21, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 21, 2022ClassClass IStatusOngoingWhereNo state named
- Medical device recall Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 21, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 21, 2022ClassClass IStatusOngoingWhereNo state named
- Medical device recall Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 21, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 21, 2022ClassClass IStatusOngoingWhereNo state named
- Medical device recall Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 21, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 21, 2022ClassClass IStatusOngoingWhereNo state named
- Medical device recall Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 21, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 21, 2022ClassClass IStatusOngoingWhereNo state named
- Medical device recall Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 21, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 21, 2022ClassClass IStatusOngoingWhereNo state named
- Medical device recall Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 21, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 21, 2022ClassClass IStatusOngoingWhereNo state named
- Medical device recall NexGen Option Stemmed Tibial Component Size 3 Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall NexGen Option Stemmed Tibial Component Size 4 Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall NexGen Option Stemmed Tibial Component Size 5 Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall NexGen Option Stemmed Tibial Component Size 6 Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall NexGen Option Stemmed Tibial Component Size 7 Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall NexGen Option Stemmed Tibial Component Size 8 Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ARTISTE, ONCOR and PRIMUS with syngo RT Therapist with software version 4.3.1 MR3 When selecting the site fraction group for treatment, the User may select the wrong site for treatment, and potentially deliver the dose to wrong isocenter Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide, and California, Iowa, Louisiana, Nebraska, Nevada, Ohio and South Carolina named
- Medical device recall BBL Chocolate II Agar- IVD for the isolation and cultivation of Neisseria species Boxes contain a reduced concentration of Nicotinamide Adenine Dinucleotide and does not provide enough of the blood factors necessary to support Haemophilus… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Foot Controlled Electrosurgical Suction Coagulator, Electrosurgical Suction Coagulator 10FR Suction ports may potentially be occluded on the affected devices. Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Leica MICROSYSTEMS Proveo 8 There is a potential issue resulting in the Power Supply potentially becoming overheated due to internal components overstressing. Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Leica MICROSYSTEMS Provido There is a potential issue resulting in the Power Supply potentially becoming overheated due to internal components overstressing. Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Leica MICROSYSTEMS M530 OHX There is a potential issue resulting in the Power Supply potentially becoming overheated due to internal components overstressing. Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CarePoint 60 mL Syringe Without Needle Syringe without needle may have a green substance on the plunger. Class IIFDA’s classDec 21, 2022in FDA’s Enforcement Report5 statesnamed in where it went PublishedDec 21, 2022ClassClass IIStatusCompletedWhereFlorida, Iowa, Louisiana, Mississippi and Puerto Rico
- Medical device recall Power-PRO 2, Model No. 6507, Item No. 650705550001 (US); 650700000000 (International) Cot may experience unintended motion due to damaged cables. Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PDS II (polydioxanone) Suture- VIOLET MONOFILAMENT 27IN 0 S/A CT-1 knot tensile strengths were observed to be significantly below the minimum knot tensile, will result in breakage prior to use or intra-operatively rather than… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall STRADIS HEALTHCARE, WECKCELL EYE SPEARS Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 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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