The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

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All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

4501–4525 of 5111

  • SevereFDA (Devices)·Z-0018-2015·2014-10-15

    Cardinal Health Prefilled Buffered 10% Formalin Recalled for Concentration Issues

    Richard-Allan Scientific Company is recalling Cardinal Health Prefilled Buffered 10% Formalin because the formalin concentration may be outside specifications.

    Product
    Cardinal Health Prefilled Buffered 10% Formalin. Product Usage:10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0058-2015·2014-10-15

    Biomet Recalls Mamba Disposable Nitinol Needles Due to Breakage Risk

    Biomet is recalling 164 Mamba Disposable Nitinol Needles because high friction may cause the needles to break during use.

    Product
    Mamba Disposable Nitinol Needle. The Biomet Sports Medicine Mamba instruments are utilized to aid in passing suture through soft tissue. The Mamba Needle is designed for use with the Mamba Suture Passer. The needles are sterile, disposable, and for single-patient use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2707-2014·2014-10-01

    Spacelabs Patient Monitor Recall for Missing Audible Alarms in End Case Mode

    Spacelabs Healthcare is recalling 222 patient monitors because they may fail to provide audible alarms in End Case mode, a defect missed in a previous recall.

    Product
    Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Arrhythmia Detection or Alarms. The Models are 91367, 91369, 91370, 91387, and 91393 are sold with Perioperative Mode (option D), which includes Start case/End case functionality, Upgrade Kit 040-1548-00.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2702-2014·2014-10-01

    Vapotherm Precision Flow Disposable Patient Circuit Recalled for Water Leaks

    Vapotherm is recalling 387 Precision Flow Disposable Patient Circuits because they may allow water to leak into the center gas lumen.

    Product
    Vapotherm Precision Flow,Disposable Patient Circuit PFNODPC-High. For use with the Precision Flow system and Ikaria INOmax DSIR ¿ System. This DPC allows clinicians to administer nitric oxide non-invasively via high flow nasal cannula. In the Precision Flow High Flow Therapy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2622-2014·2014-10-01

    ICU Medical Recalls Stat 2 Flow Controllers Due to Flow Rate Issues

    ICU Medical is recalling specific IV administration sets because the Stat 2 flow controller may deliver a significantly higher flow rate than intended.

    Product
    98" (249 cm) Appx 12.3 ml, 60 Drop Primary Set w/Pre-Slit Port, STAT 2 Flow Controller, Rotating Luer, Item No. Z2648. Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2695-2014·2014-10-01

    PDG Fuze Manual Tilt Wheelchairs Recalled for Axle Plate Detachment Risk

    PDG Product Design Group is recalling Fuze T50, T20, and T50 Jr manual tilt wheelchairs because a hex bolt head might shear, causing the axle plate to detach and the wheels to collapse.

    Product
    Fuze Manual Tilt Wheelchair. Fuze T50, Fuze T20 and Fuze T50 Jr
    Category
    Medical Device
    Distribution
    17 states
  • SevereFDA (Devices)·Z-2685-2014·2014-10-01

    Nanosphere Verigene Enteric Pathogens Test Recalled for Processing Errors

    Nanosphere is recalling 220 units of the Verigene Enteric Pathogens Nucleic Acid Test due to increased processing errors caused by Tip Holder Assemblies.

    Product
    The Verigene Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria and genetic virulence markers from liquid or soft stool preserved in Cary-Blair media, collected from indiv
    Category
    Medical Device
    Distribution
    25 states
  • SevereFDA (Devices)·Z-2642-2014·2014-09-24

    EMG Technology Recalls Vac-Assist Suction Units Due to Occluded Ports

    EMG Technology is recalling 1,452 Vac-Assist Suction Units because the canister lids may have occluded ports, potentially preventing proper fluid removal.

    Product
    Vac-Assist Suction Units (SUA01 Suction Aspirator Unit w/800 cc Canister). The suction unit is intended for professional use to remove fluids from a patient's airway or respiratory support unit. The intended population for this device is s both adult and pediatric.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2627-2014·2014-09-17

    Stryker Recalls Aria Inserter Devices Due to Product Fracturing

    Stryker Spine is recalling 57 units of Aria Standard and Specialty Implant Inserters because of complaints that the instruments fractured.

    Product
    Specialty Aria Inserter, REF IS3021ARI, Non-Sterile, This instrument is part of the Aria product brand. It is used for Implant insertion into the disc space. The Aria Inserter PEEK Spacer System offers implants that are interbody fusion devices intended for use as an aid in
    Category
    Medical Device
    Distribution
    24 states
  • SevereFDA (Devices)·Z-2608-2014·2014-09-17

    Wright Medical Recalls CLAW II Straight Plates Due to Incorrect Raw Material

    Wright Medical Technology is recalling 50 units of CLAW II Straight Plates because they were manufactured from an incorrect raw material.

    Product
    CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 20mm x 25mm, REF 40242025, 1 EACH, Rx ONLY, NON STERILE Orthopedic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2626-2014·2014-09-17

    Stryker Recalls Aria Implant Inserters Due to Product Fracturing Complaints

    Stryker Spine is recalling 64 units of Aria Standard and Specialty Implant Inserters due to complaints of product fracturing. The devices are used for spinal fusion procedures.

    Product
    Stryker Aria Implant Inserter, REF 48758500, This instrument is part of the Aria product brand. It is used for Implant insertion into the disc space. The Aria Inserter PEEK Spacer System offers implants that are interbody fusion devices intended for use as an aid in spinal f
    Category
    Medical Device
    Distribution
    24 states
  • CriticalFDA (Devices)·Z-2529-2014·2014-09-10

    Customed Recalls EO Sterilized Surgical Gowns Due to Packaging Integrity Concerns

    Customed, Inc. is recalling EO sterilized surgical gowns because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    Gown Impervious , Code 900-3190, contains: GOWN IMPERVIOUS EXTRA LONG X-LARGE WITH TOWEL & WRAP Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2321-2014·2014-09-10

    Customed Recalls Major Lap Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling Major Lap Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    MAJOR LAP PACK - (1) TABLE COVER REINF. 50" X 90" 10) GUZE SPONGE 4" X 4" 16PLY XRD (1) DRAPE T LAPAROT 102" X 78" X 121" SMS (1) UTILITY BOWL 32oz (1) TUBE CONNECT. SUCTION W X 12' (1) CAUTERY TIP POLISHER (1) YANKAUER SUCTION TUBE W/0 VENT (4) DRAPE UTILITY WITH TAPE (2) L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2356-2014·2014-09-10

    Customed Recalls Arthroscopy Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 273 units of arthroscopy packs across 11 lots because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    ARTHROSCOPY PACK- (2) ABSORBENT TOWELS 15" x 20" LIF (1) TUBE SUCTION CONNECT Y.." X 12' LIF (1) ELASTIC BANDAGE 6" X 5yrd. UF (1) IMPERVIOUS STOCKINETTE 14" X 48" (1) HUCK CLOTH TOWEL WHITE (1) MAYO STAND COVER REINFORCED LIF (1) U DRAPE 60" X70" WITH TAPE SPLIT (4) STR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2453-2014·2014-09-10

    Customed Recalls Vaginal Procedure Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling vaginal procedure packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    VAGINAL PROCEDURE PACK CUSTOM ED CONTENTS: (1) DRAPE LITHOTOMY 110" X 63" W/LEGGINGS I POUCH FEN 3 X 6 SMS LIF (1) GOWN XL SMS IMPERV. REINFORCED LIF (1) COVER MAYO STAND REINFORCED LIF (1) BAG SUTURE FLORAL (1) COVER TABLE REINF 50" X 90" LIF (1) TUBE SUC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2427-2014·2014-09-10

    Customed Recalls O.B. Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling O.B. Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    O.B. PACK - ( I) PVP SCRUB 8" STICK SPONGES ( I) UNDERBUTTOCK DRAPE WITH POUCH (2) LEGGINS WITH 7" CUFF 30" x 42" ( I) DRAPE ABDOMINAL WITH TAPE LIF ( I) VAGINAL PACKING SPONGEXRD ( I) BOWL WITH LID PLASTIC 80oz ( I) RECEIVING BLANKET 100% COTTON (I) BABY BLANKET POLY AB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2340-2014·2014-09-10

    Customed Fanfold Drapes Recalled for Potential Packaging Integrity Compromise

    Customed, Inc. is recalling Fanfold Drapes due to potential packaging integrity issues that could compromise sterility and risk patient injury.

    Product
    FANFOLD DRAPE - CUSTOMED (1) DRAPE SHEET 42" X 57" SMS (1) WRAPPER 24" X 24" EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2422-2014·2014-09-10

    Customed Recalls Endoveneous Custom Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 12 lots of Endoveneous Custom Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    ENDOVENOUS CUSTOM PACK - CUSTOMED (1) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK L/F (1) Pr. GLOVE SYNTEGRA CR # 7.5 P/F LIF (2) Pr. GLOVE SYNTEGRA CR # 6.5 P/F LIF (20) GAUZE SPONGE 4" X 4" 12PL Y LIF (3) GOWN SMS X-LARGE STD NON REINFORCED ( 1) TABLE COVER 44" X 90" (4) DRAP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2446-2014·2014-09-10

    Customed Recalls Central Line Full Body Drapes Due to Packaging Integrity Concerns

    Customed, Inc. is recalling Central Line Full Body Drapes because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    CENTRAL LINE FULL BODY DRAPE CUSTOMED CONTENTS: (1) WRAPPER 30" X 30" (2) MASK SURGICAL W/ VISOR ANTI-FOG 160mm Hg (2) CAP NURSE 21" GREEN BOUFFANT (2) TOWELS ABSORBENT 15" X 20" (2) GOWN LARGE STANDARD SMS VELCRO/NECK (1) DRAPE SHEET 41" X 58" SMS (1) DRAPE BRACHIAL AN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2320-2014·2014-09-10

    Customed Recalls Cesarean Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 30 lots of EO sterilized Cesarean Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    CESAREAN PACK - - (7) TOWELS ABSORBENT 15" X 20" (2) SCALPEL WEIGHTED SAFETY #1 0 (1) BLANKET BABY 30" X 30" POLY ABS IMP (1) BOWL UTILITY QUART 32oz. (1) TUBE FEEDING 8Fr. 15" LONG (2) COUNTER NEEDLE/BLADE 10C MAG/CLEAR (1) BEANNIES BABY (2) PAD OBSTRETICAL XLGE ST.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2381-2014·2014-09-10

    Customed Recalls Premium Ophthalmic Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 720 units of Premium Ophthalmic Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    PREMIUM OPHTHALMIC PACK- CUSTOMED- (1) GOWN SMS X-LARGE STD RAGLAN (1) CUP MEDICINE 2oz (1) DRAPE OPHTHAL. WITH POUCH LIF (1 0) SPONGE EYE SPEAR MICRO (1) SHIELD EYE UNIVERSAL (6) COTTON TIP APPLICATION 6" WOOD LIF (1 0) GAUZE SPONGES 4"X 4" 12PL Y (2) TOWELS ABSORBENT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2391-2014·2014-09-10

    Customed Recalls Plastic Surgery Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling plastic surgery packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    PLASTIC SURGERY PACK - LABEL SAMPLE CONTENTS: (2) GOWN LGE SMS NON REINF T/WRAP L/F (1) MAYO STAND COVER REINF. LIF (10) GAUZE SPONGE 4" X 4" 16 PLY LIF (1) TABLE COVER 44" X 90" (1) DRAPE SHEET 70" X 100" LIF (2) SURGICAL BLADE #15 S/STEEL (1) DRAPE HEAD WIT APE 44" X 26"
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2304-2014·2014-09-10

    Customed Laparoscopy Convenience Packs Recalled for Packaging Integrity Concerns

    Customed, Inc. is recalling 30 lots of EO sterilized laparoscopy convenience packs because packaging integrity may be compromised, potentially leading to loss of sterility and patient injury.

    Product
    Customed Laparoscopy convenience pack include multiple components: gowns, table covers, needle and blade counter, bag suture, suture, sponges/gauzes, containers, syringes 20cc & 30cc w/o needle, needle, drape, tubing, towel, dressing island, and blade surgical SS. EO steriliz
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2481-2014·2014-09-10

    Customed Recalls Shoulder Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 114 units of Shoulder Packs (Code 900-2616) because packaging integrity may be compromised, posing a risk of product contamination or loss of sterility.

    Product
    Shoulder Pack, Code 900-2616, contains: (2) TUBE SUCTION CONNECT Y."X12' UF (1) SYRINGE 20CC W/0 NDL UL UF (2) DRAPE VIDEO CAMERA UF (1) COVER MAYO STAND REINF. UF (5) SPONGE LAP. PRE-WASH XRD UF (1) DRAPE U 60" X 70" WIT APE UF (1 0) GAUZE SPONGE 4" X 4" 16PL Y XRD UF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2486-2014·2014-09-10

    Customed Recalls Surgical Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling specific lots of EO-sterilized surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    Shoulder pack (I) (2), code 900-2515 (1) GOWN IMP. XTRA REINF. XL TOWEL WRAP LEVEL Ill (1) TOWEL ABSORBENT 15" X 20" (1) GOWN XXL SMS IMPERVIOUS REINFORCED (1) MAYO STAND COVER REINFORCED (2) STRIPS TAPE 24" X 4" (1) SUTURE BAG FLORAL (1) SHEET SPLIT W/ADHESIVE 1 08" X 77"
    Category
    Medical Device
    Distribution
    Distributed nationwide