Recalls in 2021
Records start Oct 2021
By month
Most recalled brands
Drugs & medical recalls in the United States in 2021
- 2021-12-29
USMedtronic Navigation, Inc. recalls Stealth Autoguide Tracker, Model: 28248, which is an instrument in the Stealth Autoguide Basic Instrument Kit, Mode: 9736188, and the…
A tracker that holds and guides neurosurgical surgical instruments may be subject to separation/weld failure, where the tracker connects to the instrument tube. If a weld separation occurs and a navigation inaccuracy…
FDA · DeviceMedtronic Navigation, Inc.US: FL, NE, CA, MN, TX, OH, IL, AZ, KS, KY, OR, OK, WA, NV, MO, IN, MI, UT,…Official notice →- US
Philips North America Llc recalls Philips Allura Xper FD series with Software Version Number: 2.1.x- intended for Vascular, cardiovascular and neurovascular imaging…
Set screws securing the two gliding rods of the Extra Monitors (called 7th and 8th monitor) mounted on the Monitor Ceiling Suspension (MCS) can come loose, the Extra monitors might disengage from the Mounting Ceiling…
FDA · DevicePhilips North America LlcWorldwide distribution - US Nationwide distribution in the states of DC, GA,…Official notice → - US
Acclarent, Inc. recalls TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS070Z; and 90-Degree, REF: TDNS090Z
Suction Instruments were incorrectly calibrated so they may not meet the system accuracy specification for visual verification of device location in the patient anatomy. If the surgeon does not detect the accuracy…
FDA · DeviceAcclarent, Inc.US: AZ, MI, IA, LA, IL, VA, SC, NY, IN, OR, SD, TX, PA, NE, FL, CT, MN, NV,…Official notice → - US
Cook Inc. recalls Skinny Needle with Chiba Tip. RPN 090010, 090010-ET; GPN G14254, G15290. Rigid needle available with EchoTip to provide enhanced…
Specific lots may contain black debris on the exterior of the inner stylet and/or on the interior of the outer cannula. Local inflammatory reactions may occur if an affected product is used.
FDA · DeviceCook Inc.Worldwide distribution - US Nationwide distribution in the states of AL, CA,…Official notice → - US
Coloplast Manufacturing US, LLC recalls Torosa Saline-Filled Testicular Prosthesis (Size Small)
Product is mislabeled for size.
FDA · DeviceColoplast Manufacturing US, LLCWorldwide distribution - US Nationwide distribution and the country of Canada.Official notice → - US
Leica Microsystems, Inc. recalls Leica Microsystems M220 F12 Microscope Systems
In May 2021, Leica Microsystems received one (1) complaint pertaining to the M220 F12 Surgical Microscope system. There was no patient injury reported for this complaint. However, the identified defect carries some…
FDA · DeviceLeica Microsystems, Inc.Worldwide distribution - US Nationwide distribution in the states of CA, DC,…Official notice → - US
ROi CPS LLC recalls regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit, containing 2 25GA x .625IN needles.
The kit contains a non-sterile needle.
FDA · DeviceROi CPS LLCDistribution was made to Missouri. There was no foreign/military/government…Official notice → - US
Beaver Visitec International, Inc. recalls Malosa Core SMILE Pack 1-Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part…
Kit packaging may have small holes compromising product sterility
- US
MEDLINE INDUSTRIES, LP - Northfield recalls Stanbio TDM/B-Hydroxybutyrate Tri-Level Controls, Ref. No. 2460-605
Affected product was shipped from the warehouse at room temperature instead of the required refrigerated environment.
FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldUS Nationwide distribution in the states of IL, OH, MS, and PA.Official notice → - US
Maquet Cardiovascular, LLC recalls Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890
There is a probable mislabeling of product. A Hemashield Platinum Woven Double Velour Bifurcated Vasuclar Graft, SN 1259735369, 24 mm x 12 mm, REF Number M00202166241P0 is likely packaged inside of the carton instead…
FDA · DeviceMaquet Cardiovascular, LLCUS Nationwide distribution in the states of IL and NC.Official notice → - US
Hill-Rom Inc. recalls These are communication systems, labeled as: a. NaviCare Nurse Call, Part Numbers: 3.6, 3.7, 3.9 b. Voalte Nurse Call, Part Number 4.0…
An unrecoverable error may occur where a component will fail to complete the reboot cycle, become non-functional and must be replaced.
- US
Wright Medical Technology, Inc. recalls Wright Medical Technology Inc. CHARLOTTE MTP Hex Screw, Model #41122718, 2.7mm x 18mm, a component of the CHARLOTTE Lisfranc…
Incorrect product is contained in the packaging.
FDA · DeviceWright Medical Technology, Inc.Worldwide distribution - US Nationwide distribution in the states of AZ, IA,…Official notice → - US
Stradis Medical, LLC dba Stradis Healthcare recalls Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk
This recall has been initiated to address bulk packed, non-sterile Intravascular Administration Sets that were erroneously distributed to fill orders for the sterile version of the same Intravascular Administration Set.
FDA · DeviceStradis Medical, LLC dba Stradis HealthcareNJ, MI, MA, NY, TX, CO, NC, CT, OR, OHOfficial notice → - US
Beckman Coulter Inc. recalls SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825
Cholesterol Reagent may fail with Out of Calibration Range Low (OCR Low) and/or Back to Back (B/B) errors. Low quality control recovery failures may be observed after passing calibration. Brown particulates in…
FDA · DeviceBeckman Coulter Inc.US Nationwide distribution in the states of Louisiana, Ohio, North Carolina,…Official notice → - US
Civco Medical Instruments Co. Inc. recalls VirtuTRAX Instrument Navigator, 14 Ga VirtuTRAX
There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.
FDA · DeviceCivco Medical Instruments Co. Inc.Worldwide distribution - US Nationwide and the countries of Belgium, Canada,…Official notice → - US
Cardiovascular Systems Inc recalls WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval Catheter, 6Fr, REF (Model Number) WRN-D6
Under certain circumstances, the WIRION filter assembly may become difficult to withdraw. Under such circumstances, alternative means may be necessary for withdrawal and the device may be prone to tearing or separating…
FDA · DeviceCardiovascular Systems IncUnited States- AK, AL, AR, AZ, CA, DC, FL, GA, GU, HI, IA, IL, IN, KY, LA, MA,…Official notice → - US
Wright Medical Technology Inc recalls Stryker DARCO Screw, Locking, Ti6A14V, REF DC2825016, 2.7mm x 16mm.
The incorrect product is contained in the packaging.
FDA · DeviceWright Medical Technology IncWorldwide distribution in the states of AZ, IA, ID, NC, NY, VA, and WV. The…Official notice → - US
Medtronic Navigation, Inc. recalls Stealthstation System w/ Stealthstation Cranial Software 3.1.1,3.1.2,3.1. or SynergyCranial Software. Synergy Cranial, Model:…
Cranial biopsy procedure software can enter a state where the biopsy depth gauge is no longer synchronized with the rest of the navigational information on the screen and may display an incorrect position of the biopsy…
FDA · DeviceMedtronic Navigation, Inc.US: MN, FL, MD, IL, AK, NE, NH, PA, ND, AR, CA, WI, NJ, GA, SD, AZ, KY, AL,…Official notice → - US
- US
Efficient Laboratories, Inc. recalls Rompe Pecho Max Multi-Symptoms Maximum Strength, 8 Fl. Oz. (237 mL) bottles, Distributed by: Efficient Laboratories, Inc. Miami, FL…
Microbial Contamination of Non-Sterile Products
- US
The Harvard Drug Group recalls Fexofenadine Hydrochloride Tablets, 60 mg, 500 Tablets per bottle, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Drive,…
Failed Impurities/Degradation Specifications
- US
Denver Solutions, LLC DBA Leiters Health recalls Moxifloxacin, 1 mg/mL, 1mL in 2mL vial, solution for intracameral injection, 10 vials/carton, Rx only, Leiters 13796…
Labeling: Label Mix-up: Vials labeled as moxifloxacin 1 mg/mL may actually contain moxifloxacin 5 mg/mL
FDA · DrugDenver Solutions, LLC DBA Leiters HealthNationwide within the United StatesOfficial notice → - US
Medline Industries Inc recalls Hand Sanitizer Foam (ethyl alcohol), 62% v/v, packaged in a) 1.5 Oz. cans, NDC 53329-970-12; b) 8 Oz. (227 g) cans, NDC 53329-970-08; and…
Defective Container: Customer complaints for leaking bottles and dispensing issues.
- 2021-12-22
- US
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN 6935M72
The back of some Medical Device Identification Cards provided to patients were printed with an erroneous statement stating the following: "This patient has a complete MR conditional system implanted."
FDA · DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)US, Canada, Northern Mariana IslandsOfficial notice → - US
Xstrahl Limited recalls Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system
Base plate may detach from the main body of the treatment applicator.
FDA · DeviceXstrahl LimitedUS and ALGERIA, AUSTRALIA, AUSTRIA, BULGARIA, CANADA, COSTA RICA, CROATIA,…Official notice → - US
Cook Inc. recalls Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-7.0-18/38-45-RB-ANL0-HC Order Number/GPN: G44155 Intended to introduce…
Flexor Check-Flo Introducer Ansel Modification mislabeled. Products packaged with a label stating 6FR may contain a 7FR device and vice versa
FDA · DeviceCook Inc.AL, AZ, CA, FL, GA, KS, MI, MO, MN, NC, NY, OK, TX Foreign: BE, CH, DE, ES,…Official notice → - US
Activbody, Inc. recalls Box Label: activ5 TINY GYM IN YOUR POCKET activbody Model: Activ5 User Manual: ACTIV5 USER MANUAL Welcome to Activ5, the first…
Due to: 1) Manufacturing issue that result in inaccurate force measurement which may lead to may potential lead to incorrect treatment planning. 2) Firm failing to register and list its medical devices with U.S. Food…
FDA · DeviceActivbody, Inc.U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, LA MA,…Official notice → - US
CryoLife, Inc. recalls BioGlue Surgical Adhesive, Model BG3510-5-G
Product is not approved for use in the EU and should not have been distributed in the EU.
FDA · DeviceCryoLife, Inc.Distribution in the European Union only (Germany/Switzerland)Official notice → - US
Clark Laboratories, Inc. recalls Bartels Legionella Urinary Antigen- an adjunct to culture for the presumptive diagnosis of past or current Legionnaire's Disease by…
Contamination of the conjugate may cause a pipetting issue which then could lead to an invalid assay
- US
Boston Scientific Corporation recalls Boston Scientific ROTAPRO, Rotational Atherectomy System Console, Model numbers H74939309010 (US) and H74939309030 (EU).
Manufacturing instructions did not include the directions to not retest the pneumatic kit component of the ROTAPRO console upon failure, an internal nonconformity.
FDA · DeviceBoston Scientific CorporationWorldwide distribution - US Nationwide distribution in the states of FL, NV,…Official notice → - US
Ossur Americas recalls Miami J Select Collar, Item: MJS-101, and Miami J Select Collar Set, Item: MJSR-101 Instructions for Use
Instructions for use were updated to include additional information to facilitate the selection and use of the collar device.
FDA · DeviceOssur AmericasUS Nationwide distribution in the states of CA, NH, CT, RI, MA, FL, DE, NY,…Official notice → - US
Olympus Corporation of the Americas recalls EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V Model Number: TJF-Q180V
Use of a TJF-Q180V with adhesive deterioration or other damages may pose a risk of endoscope contamination due to ineffective reprocessing or fluid invasion; contaminated endoscope can present an infection risk to…
- US
Cardinal Health recalls RoyalSilk Non-Reinforced Surgical Gowns X-large SKU: 9548
Potential for open packaging seals compromising the sterility of the surgical gowns
FDA · DeviceCardinal HealthWorldwide distribution - US Nationwide and the countries of Chile, Thailand,…Official notice → - US
Mentor Texas, LP. recalls MENTOR Saline-Filled Breast Implants are constructed from room temperature vulcanized silicone elastomer, made of polydimethylsiloxane.…
Due to a manufacturing issue, Implant may have a potentially weakened area on the base patch portion of the implant which may cause leakage/deflation of the affected device.
FDA · DeviceMentor Texas, LP.Worldwide distribution - U.S. Nationwide distribution in the states of AK, AL,…Official notice → - US
Smith & Nephew, Inc. recalls smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM, REF 72573101
Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was incorporated in the released IFU 81110294 EVOS Large…
FDA · DeviceSmith & Nephew, Inc.US Nationwide distribution in the states of CO, FL, GA, MA, MN, MO, NC, NJ,…Official notice → - US
Medline Industries Inc recalls EVLP Convenience Pack/Kit
NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.
- US
Datascope Corp. recalls Cardiosave Rescue IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-75, 0998-UC-0800-75, 0998-00-0800-83, 0998-UC-0800-83,…
Firm is initiating a correction due to the possibility of fluid ingress. Fluid entering the device may short various electronic components thus leading to system shutdown, which could result in unsafe hemodynamic…
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