Medical device recalls
38685 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2022-12-14FDA-DeviceCaire, Inc.Class ICAIRE Liberator 45, MODEL 13261699, Liquid Oxygen System Unit
An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner bottle of the device on some of the units.
- 2022-12-14FDA-DeviceRemel IncClass IThermo SCIENTIFIC, Sensititre STP7F, Gram Negative IVD AST
An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam.
- 2022-12-14FDA-DeviceRemel IncClass IThermo SCIENTIFIC, Sensititre STP6F, Gram Negative IVD AST
An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam.
- 2022-12-14FDA-DeviceRemel IncClass IThermo SCIENTIFIC, Sensititre MDRGN3F, Gram Negative IVD AST
An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam.
- 2022-12-14FDA-DeviceRemel IncClass IThermo SCIENTIFIC, Sensititre CMC7AFLF, Gram Negative IVD AST
An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam.
- 2022-12-14FDA-DeviceRemel IncClass IThermo SCIENTIFIC, Sensititre CMC5VGNF, Gram Negative IVD AST
An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam.
- 2022-12-14FDA-DeviceRemel IncClass IThermo SCIENTIFIC, Sensititre HPB1, Gram Negative IVD AST
An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam.
- 2022-12-14FDA-DeviceRemel IncClass IThermo SCIENTIFIC, Sensititre GN7F, Gram Negative IVD AST
An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam.
- 2022-12-14FDA-DeviceRemel IncClass IThermo SCIENTIFIC, Sensititre GN6F, Gram Negative IVD AST
An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam.
- 2022-12-14FDA-DeviceRemel IncClass IThermo SCIENTIFIC Sensititre Plate, GN4F, Gram Negative IVD AST
An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam.
- 2022-12-14FDA-DeviceDEWEI MEDICAL EQUIPMENT CO LTDClass IDewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B
Products were distributed in the United States without FDA authorization or clearance.
- 2022-12-07FDA-DeviceAlcon Research, LLCClass IIAlcon Custom Pak Surgical Procedure Pack
Due to difficulty removing the liner on the adhesive components of the affected drapes and as a result may render the product unusable. In addition, the manufacturer of the drapes has observed an increase in reported adhesive related skin injuries for these affected lots.
- 2022-12-07FDA-DeviceCytocell Ltd.Class IICytoCell BCL11B Proximal in FITC Spectrum-LDT for investigation T-cell related malignancy. This device is an analyte specific reagent probe covering the 14q32.2 locus proximal to the BCL11B gene on chromosome 14. Ref: MPD39781
Device is mislabeled. The package insert for this ASR device contains a chromomap - an image showing the position the FISH probe maps to on the specific chromosome. For this device the chromomap in version 1 of the package insert is incorrect and doesn't not match the probe design or specification contained on the package insert
- 2022-12-07FDA-DevicePrimus Corporation dba Trinity BiotechClass IIITrinity Biotech HbA1c (GHb) Contorls Kit, 500uL (Levels I & II), REF 01-04-0020, Part number 05-01-0040B, A1c analysis
The Control Level I material value was showing results exceeding the upper limit of the acceptable range after a period of three (3) months. Additionally, per the firm, the unacceptable Control Level 1 value results in the Analyzer generating an error code which stops further testing and nullifies associated patient samples, resulting in a delay in patient results and a potential delay in therapeutic modifications.
- 2022-12-07FDA-DevicePrimus Corporation dba Trinity BiotechClass IIIA. MENARINI diagnostics Hb 9210 PREMIER, LEVEL1, LEVEL II, Hemoglobin A1c Controls for hemoglobin A1c Assay, REF 45052, part number 05-01-0926, A1c analysis
The Control Level I material value was showing results exceeding the upper limit of the acceptable range after a period of three (3) months. The unacceptable Control Level 1 value results in the Analyzer generating an error code which stops further testing and nullifies associated patient samples, resulting in a delay in patient results and a potential delay in therapeutic modifications.
- 2022-12-07FDA-DeviceGreer Laboratories, Inc.Class IIGREER DIA - KIT ANTIGEN M. FAENI, 2.0mL 20 MG/ML, Analyte Specific Reagent, Item: K62, HYPERSENSITIVITY PNEUMONITIS test system, gel diffusion kit for demonstrating precipitating antibodies.
The product was recalled because stability evaluation of the lots indicated a decrease in reactivity that could lead to a potential false-negative result interpretation. The issue was identified by the firm after failing to meet lot requirements for potency. The lot release error was discovered on October 08, 2021, after a failed potency test was determined during 6-month stability evaluation of retention material for the lots. The subsequent manufacturing investigation, which included a review of the lot release potency documentation, found that the initial lot release potency test for the lot was misinterpreted.
- 2022-12-07FDA-DeviceGreer Laboratories, Inc.Class IIGREER M. FAENI, 0.25 mL 20 MG/ML, Item: K6, Analyte Specific Reagent, HYPERSENSITIVITY PNEUMONITIS test system, gel diffusion kit for demonstrating precipitating antibodies.
The product was recalled because stability evaluation of the lots indicated a decrease in reactivity that could lead to a potential false-negative result interpretation. The issue was identified by the firm after failing to meet lot requirements for potency. The lot release error was discovered on October 08, 2021, after a failed potency test was determined during 6-month stability evaluation of retention material for the lots. The subsequent manufacturing investigation, which included a review of the lot release potency documentation, found that the initial lot release potency test for the lot was misinterpreted.
- 2022-12-07FDA-DeviceAccelerate Diagnostics IncClass IIAccelerate PhenoTest BC kit REF 10102018
Due improperly formulated and released bulk lot of fluorescence in situ hybridization (FISH) probes resulting in false positive identification results for Staphylococcus aureus and Streptococcus spp.
- 2022-12-07FDA-DeviceAccelerate Diagnostics IncClass IIAccelerate PhenoTest BC kit REF 10101018
Due improperly formulated and released bulk lot of fluorescence in situ hybridization (FISH) probes resulting in false positive identification results for Staphylococcus aureus and Streptococcus spp.
- 2022-12-07FDA-DeviceMobius Imaging, LLCClass IIMobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography (CT) system, software version 2.1.1
Stryker received a report of a battery fire involving an Airo TruCT unit previously subjected to bypass charging. The firm is notifying customers with units whose battery monitoring systems were bypassed to charge the batteries; the batteries in these units require replacing.
- 2022-12-07FDA-DeviceOwens & Minor Distribution, Inc.Class IIAero Blue Performance Surgical Gown, XL- Sterile surgical gown Code: 41734
Potential open seal pouches compromising sterility resulting in the use of a non-sterile product in surgery could lead to patient infection
- 2022-12-07FDA-DeviceBio-Rad Laboratories, Inc.Class IICMV IgM EIA, in vitro diagnostic.
Due to an unusual increase in the positivity rate with human IgM antibodies to cytomegalovirus (CMV) Enzyme Immunoassay (EIA).
- 2022-12-07FDA-DeviceCytocell Ltd.Class IICytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD39782
An error with the chromomap on version 1 of the package insert which is incorrect. The nucleotide locations specified in the insert are correct but the map has been created using the wrong coordinates.
- 2022-12-07FDA-DeviceIntuitive Surgical, Inc.Class IIINTUITIVE Da Vinci Xi 8mm SureForm 30 Curved-Tip Stapler Da Vinci Xi|X REF 488530 INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm Gray 4-Row 2.0 mm Xi|X REF 48230M INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm White 4-Row 2.5 mm Xi|X REF 48230W INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm Blue 4-Row 3.5 mm Xi|X REF 48230B
Potential staple deployment failure and device fragment generation
- 2022-12-07FDA-DeviceBusse Hospital Disposables, Inc.Class IIBusse SPINE INJECTION TRAY-Intended as a nerve block REF No. 8563R1
Kits containing 3M Steri-Drape Surgical Drapes recalled by 3M due to liner on the adhesive component is difficult to remove without damaging the product and may render the product unusable
- 2022-12-07FDA-DeviceBusse Hospital Disposables, Inc.Class IIBusse JOINT INJECTION TRAY -Intended as a nerve block REF No. 8561 R1
Kits containing 3M Steri-Drape Surgical Drapes recalled by 3M due to liner on the adhesive component is difficult to remove without damaging the product and may render the product unusable
- 2022-12-07FDA-DeviceGS Biomark LLCClass IICoViPoint COVID test kit (MultiPLEX/Direct) Kit Item Numbers: BC-DK0200; BM-AD4K0200 BM-ADK0200 BM-CDK0200 BM-CFDK0200 BM-D4K0200 BM-DK0200 BM-DK0600 BM-DK0800 BM-DK1200 BM-DK1400 BM-DK1800
Distribution of COVID Test Kits without FDA Approval, Clearance or Authorization.
- 2022-11-30FDA-DeviceROi CPS LLCClass IIregard SHOULDER ARTHROSCOPY, OR01103A, Item Number 880471001; ortho surgery convenience kit
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
- 2022-11-30FDA-DeviceROi CPS LLCClass IIregard SPINE, OR01100A, Item Number 880468001; ortho surgery convenience kit
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
- 2022-11-30FDA-DeviceROi CPS LLCClass IIregard HIP ARTHROSCOPY, OR01092B, Item Number 880462002; ortho surgery convenience kit
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
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